CancerEASTNCT05283577
Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors
A study testing Electroacupuncture in people with Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a sham-controlled, patient and assessor-blinded pilot trial to evaluate the feasibility of administering EA as an intervention for symptom clusters in cancer patients and survivors, and to evaluate the degree that EA could reduce symptom clusters and the possible underlying mechanisms through examining its… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with cancer that have received anti-cancer treatment
- 16 years of age or older
- Life expectancy ≥ 6 months
- Complaints of one or more of the following symptoms: memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past 7 days
Who cannot join
- Presence of metastasis
- Severe needle phobia
- Severe psychiatric or medical disorders which would affect cognitive assessments
- Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
- Has pacemaker or other electronic metal implants
- Epilepsy
Show all 10Show fewer
- Already receiving acupuncture therapy or received acupuncture treatment in the past 3 months.
- Breastfeeding, pregnant or are planning get pregnant during the study period
- Additional exclusion criteria for optional neuroimaging procedure:
- Has any contraindications to fMRI including metal fragments/implants in the body, sever claustrophobia, and non-removable metal orthodontic braces, metallic retainers and oral wires.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Health Susan Samueli Integrative Health Institute
Irvine, California, 92697
About this study
Official title: Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors (EAST): A Feasibility Study
This is a sham-controlled, patient and assessor-blinded pilot trial to evaluate the feasibility of administering EA as an intervention for symptom clusters in cancer patients and survivors, and to evaluate the degree that EA could reduce symptom clusters and the possible underlying mechanisms through examining its influence on biomarkers that are linked with the symptoms.
Participants will be randomized to either the treatment arm (those who will receive EA) or the control arm (those who will receive sham-EA). The treatment period for both groups will be 10 weeks. There will be one study visit a week over the course of the 10-week treatment period, for a total of 10 study treatment visits. Participants in the treatment arm will receive EA at 13 standardized acu-points that have been chosen for their therapeutic effects. Participants in the control arm will receive electrical stimulation at non-disease acu-points. There will be four data collection time points for each participant: (1) baseline, (2) mid-treatment (5 weeks from baseline), (3) end of treatment (10 weeks from baseline), and (4) 4 weeks after end of treatment (14 weeks from baseline). At each of these timepoints, 10mL of peripheral blood will be collected for a biomarker analysis and participants will be asked to complete 4 questionnaires and a computerized cognitive test to evaluate their cognitive function, fatigue level, insomnia, psychological distress, and quality of life. An optional neuroimaging procedure will be available to all eligible participants. In total, study participation will last for 14 weeks.
Read the detailed description
The purpose of this study is to investigate the efficacy, safety, and feasibility of offering electroacupuncture as an intervention to improve cancer-related symptoms (cognitive impairment, fatigue, psychological distress and insomnia) and quality of life among cancer patients and survivors receiving care at UCI Health. In addition, changes in biomarkers (plasma BDNF, pro-inflammatory cytokines and mitochondrial DNA) known to be associated with cancer-related symptoms. We hypothesize that EA is an effective, safe, and feasible intervention for cancer patients and survivors.
Our specific aims are as follows:
- To compare the efficacy of EA versus sham-EA control in reducing cognitive toxicity, fatigue, psychological distress, insomnia, and to improve quality of life.
- To evaluate the impact of EA versus sham-EA control on biomarkers, including circulating BDNF, pro-inflammatory cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha), mitochondrial DNA (oxidative stress indicator).
- To compare the reduction of structural (brain gray matter) and functional connectivity at the prefrontal, medial temporal, and parietal brain regions pre- and post-EA treatment.
- To assess the safety and feasibility of administering EA to manage symptom clusters in cancer patients and survivors.
- As the UCI MINDS C2C registry (UCI IRB Approval #: HS# 2015-2494) will be leveraged to recruit some patients, we will quantify the characteristics associated with non-response to our study advertisement among C2C registrants using C2C-collected data.
- Conditions
- Cancer
- Being tested
- Electroacupuncture, Sham-Electroacupuncture
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
EA at 13 standardized acu-points that were chosen for their therapeutic effects: Shenting (GV24), Baihui (DU20), Sinshencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6) bilateral, Shenmen (HT7) bilateral, Zusanli (ST36) bilateral, Sanyinjiao (SP6) bilateral, Taixi (KI3) bilateral, Zhaohai (KI6) bilateral, Hegu (LI4) bilateral, Taichong (LIV3) bilateral
Sham-ElectroacupunctureOther
Non-disease related points with electrical stimulation: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Fuyang (BL59) bilateral, Kunlun (BL60) bilateral, Sanyangluo (TE8), Sidu (TE9) bilateral, Daheng (SP15) bilateral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Each participant will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 13 standardized acu-points that were chosen for their therapeutic effects. Receives: Other: Electroacupuncture |
| Control Arm | Sham comparator | Each participant in the control arm will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Participants in the control arm will receive electrical stimulation at non-disease related acu-points for approximately 1 hour per session. Receives: Other: Sham-Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive Function (FACT-Cog version 3)
All subjects will complete the FACT-Cog version 3 questionnaire to assess self-perceived subjective cognitive function. FACT-Cog is a validated questionnaire containing 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning.
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Secondary outcomes (25)
Objective Cognitive Function (CANTAB®,)
All subjects will complete Cambridge Neuropsychological Test Automated Battery (CANTAB®), to assess objective cognitive functions. CANTAB® is a computerized cognitive testing software to assess various cognitive domains. Both subjective and objective assessments are recommended by the International Cognition and Cancer Task Force (ICCTF).
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Fatigue (MFSI-SF)
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a validated questionnaire that comprises of 30 items and contains 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The total score is obtained by subtracting the vigour subscale from the sum of all the dimensions (total score range from 24 to 96), with a higher score indicating higher fatigue level.
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Psychological Distress and Insomnia (RSCL)
The Rotterdam Symptom Checklist (RSCL) will be used to measure the psychological symptoms (anxiety and depression) and insomnia. Psychological distress is indicated by a score of >16 in the psychological domain (range 7 to 28). Insomnia is measured by a single item in the checklist (not at all, a little, quite a bit, very much).
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Quality of Life (EORTC QLQ-30)
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) is a validated questionnaire developed to assess cancer patients' health-related quality of life. It incorporates 5 functional scales (cognitive, emotional, physical, role, and social), symptom scales (e.g. pain, fatigue, insomnia), and a global health scale. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale. Higher scores represent a better global health status and better degree of functioning while lower symptom scores indicate less severe symptoms.
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Quality of Life (EQ-5D-5L)
EQ-5D comprises a visual analog scale of general health status ranging from 0 (worst imaginable) to 100 (best imaginable) and a descriptive system based on five dimensions of health status: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D descriptive index responses were mapped into a single dimension health utility index (UI) ranging from death (0) to full health (1), with health states worse than death being possible (<0), by using utility weights for the US population.
Measured: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Safety Monitoring
Participants will be monitored for adverse events such as bruising, pain or discomfort, bleeding and possible infections. Severity are graded according to the Common Terminology Criteria for Adverse Events V5.
Measured: Through study completion, an average of 14 weeks per participant.
Biomarkers - Plasma BDNF (pg/ml)
Plasma brain-derived neurotropic factor (BDNF) levels at each time point, and changes from baseline
Measured: BDNF levels will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
Plasma cytokine levels at each time point, and changes from baseline
Measured: Cytokine levels will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Mitochondrial DNA content
Mitochondrial DNA (mtDNA) content at each time point, and changes from baseline
Measured: mtDNA content will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Gray matter volume
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - White matter volume
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Mean diffusivity
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Fractional anisotropy
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Radial diffusivities
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Axial diffusivities
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Resting state functional connectivities
Neuroimaging scans (rsfMRI, FLAIR, diffusion weighed, T1-weighted and T2-weighted sequences)
Measured: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Feasibility - Recruitment (number of participants recruited)
The number of participants recruited (% of target recruitment)
Measured: Through study completion, approximately 2 years.
Feasibility - Recruitment (rate of recruitment)
Number of patients recruited per month
Measured: Through study completion, approximately 2 years.
Feasibility - Recruitment (reasons for declining participation)
Reasons for declining participation will be documented.
Measured: Through study completion, approximately 2 years.
Feasibility - Recruitment (time spent on recruitment)
Time spent on recruitment, in minutes, wil be documented to assess recruitment productivity.
Measured: Through study completion, approximately 2 years.
Feasibility - Compliance (number of acupuncture sessions successfully completed)
Number of acupuncture sessions successfully completed in total
Measured: Through study completion, approximately 2 years.
Feasibility - Compliance (proportion of participants completing the scheduled acupuncture sessions)
Proportion of participants completing all the scheduled acupuncture sessions
Measured: Through study completion, approximately 2 years.
Feasibility - Acceptability
Study participants will complete a questionnaire evaluating their perceptions towards the EA treatment at the end of treatment.
Measured: Upon completion of treatment, at 10 weeks from baseline.
Feasibility - Satisfaction
Participants will be asked if they are satisfied and benefited from the treatment, and whether they would consider undergoing treatment again outside of a trial setting.
Measured: Upon completion of treatment, at 10 weeks from baseline.
Feasibility - Blinding assessment
Participants will be asked whether they believe that they have received EA or sham-EA at the end of treatment.
Measured: Upon completion of treatment, at 10 weeks from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized sham-controlled, patient and assessor-blinded pilot trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Chan, University of California, Irvine
- Investigators
- Alexandre Chan, PharmD, Principal investigator, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283577
- Sponsor's protocol ID
- 20216732
- Acronym
- EAST
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
PubMed 28029304Ng T, Dorajoo SR, Cheung YT, Lam YC, Yeo HL, Shwe M, Gan YX, Foo KM, Loh WK, Koo SL, Jain A, Lee GE, Dent R, Yap YS, Ng R, Chan A. Distinct and heterogeneous trajectories of self-perceived cognitive impairment among Asian breast cancer survivors. Psychooncology. 2018 Apr;27(4):1185-1192. doi: 10.1002/pon.4635. Epub 2018 Feb 1.
PubMed 29315963Cheung YT, Ng T, Shwe M, Ho HK, Foo KM, Cham MT, Lee JA, Fan G, Tan YP, Yong WS, Madhukumar P, Loo SK, Ang SF, Wong M, Chay WY, Ooi WS, Dent RA, Yap YS, Ng R, Chan A. Association of proinflammatory cytokines and chemotherapy-associated cognitive impairment in breast cancer patients: a multi-centered, prospective, cohort study. Ann Oncol. 2015 Jul;26(7):1446-51. doi: 10.1093/annonc/mdv206. Epub 2015 Apr 28.
PubMed 25922060Toh YL, Tan CJ, Yeo AHL, Shwe M, Ho HK, Gan YX, Foo KM, Chu P, Olson K, Chan A. Association of plasma leptin, pro-inflammatory adipokines and cancer-related fatigue in early-stage breast cancer patients: A prospective cohort study. J Cell Mol Med. 2019 Jun;23(6):4281-4289. doi: 10.1111/jcmm.14319. Epub 2019 Apr 23.
PubMed 31016867Cheung YT, Shwe M, Chui WK, Chay WY, Ang SF, Dent RA, Yap YS, Lo SK, Ng RC, Chan A. Effects of chemotherapy and psychosocial distress on perceived cognitive disturbances in Asian breast cancer patients. Ann Pharmacother. 2012 Dec;46(12):1645-55. doi: 10.1345/aph.1R408. Epub 2012 Dec 18.
PubMed 23249868Liou KT, Root JC, Garland SN, Green J, Li Y, Li QS, Kantoff PW, Ahles TA, Mao JJ. Effects of acupuncture versus cognitive behavioral therapy on cognitive function in cancer survivors with insomnia: A secondary analysis of a randomized clinical trial. Cancer. 2020 Jul 1;126(13):3042-3052. doi: 10.1002/cncr.32847. Epub 2020 Apr 22.
PubMed 32320061Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
PubMed 32305573Tong T, Pei C, Chen J, Lv Q, Zhang F, Cheng Z. Efficacy of Acupuncture Therapy for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients. Med Sci Monit. 2018 May 8;24:2919-2927. doi: 10.12659/MSM.909712.
PubMed 29735975Zeng Y, Cheng ASK, Song T, Sheng X, Wang S, Xie J, Chan CCH. Effects of Acupuncture on Cancer-Related Cognitive Impairment in Chinese Gynecological Cancer Patients: A Pilot Cohort Study. Integr Cancer Ther. 2018 Sep;17(3):737-746. doi: 10.1177/1534735418777109. Epub 2018 May 26.
PubMed 29806502Ng DQ, Heshmatipour M, Trudeau J, Sridhar A, Pluimer B, Drayson OGG, Lavasani SM, Parajuli R, Lee S, Agrawal A, Acharya MM, Limoli CL, Harris RE, Xie L, Malik S, Chan A. Electroacupuncture improves cognitive function and neuropsychiatric symptoms in breast cancer survivors: a pilot randomized controlled trial. J Natl Cancer Inst. 2026 Apr 2:djag096. doi: 10.1093/jnci/djag096. Online ahead of print.
PubMed 41926740Xie L, Ng DQ, Heshmatipour M, Acharya M, Coluzzi P, Guerrero N, Lee S, Malik S, Parajuli R, Stark C, Tain R, Zabokrtsky K, Torno L, Chan A. Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST). BMC Complement Med Ther. 2023 Mar 27;23(1):92. doi: 10.1186/s12906-023-03926-9.
PubMed 36973688
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for the Management of Symptom Clusters in Cancer Patients and Survivors (EAST): A Feasibility Study
- ClinicalTrials.gov ID
- NCT05283577
- Acronym / sponsor ID
- EAST / 20216732
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a sham-controlled, patient and assessor-blinded pilot trial to evaluate the feasibility of administering EA as an intervention for symptom clusters in cancer patients and survivors, and to evaluate the degree that EA could reduce symptom clusters and the possible underlying mechanisms through examining its influence on biomarkers that are linked with the symptoms.
Participants will be randomized to either the treatment arm (those who will receive EA) or the control arm (those who will receive sham-EA). The treatment period for both groups will be 10 weeks. There will be one study visit a week over the course of the 10-week treatment period, for a total of 10 study treatment visits. Participants in the treatment arm will receive EA at 13 standardized acu-points that have been chosen for their therapeutic effects. Participants in the control arm will receive electrical stimulation at non-disease acu-points. There will be four data collection time points for each participant: (1) baseline, (2) mid-treatment (5 weeks from baseline), (3) end of treatment (10 weeks from baseline), and (4) 4 weeks after end of treatment (14 weeks from baseline). At each of these timepoints, 10mL of peripheral blood will be collected for a biomarker analysis and participants will be asked to complete 4 questionnaires and a computerized cognitive test to evaluate their cognitive function, fatigue level, insomnia, psychological distress, and quality of life. An optional neuroimaging procedure will be available to all eligible participants. In total, study participation will last for 14 weeks.
Detailed description
The purpose of this study is to investigate the efficacy, safety, and feasibility of offering electroacupuncture as an intervention to improve cancer-related symptoms (cognitive impairment, fatigue, psychological distress and insomnia) and quality of life among cancer patients and survivors receiving care at UCI Health. In addition, changes in biomarkers (plasma BDNF, pro-inflammatory cytokines and mitochondrial DNA) known to be associated with cancer-related symptoms. We hypothesize that EA is an effective, safe, and feasible intervention for cancer patients and survivors.
Our specific aims are as follows:
- To compare the efficacy of EA versus sham-EA control in reducing cognitive toxicity, fatigue, psychological distress, insomnia, and to improve quality of life.
- To evaluate the impact of EA versus sham-EA control on biomarkers, including circulating BDNF, pro-inflammatory cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha), mitochondrial DNA (oxidative stress indicator).
- To compare the reduction of structural (brain gray matter) and functional connectivity at the prefrontal, medial temporal, and parietal brain regions pre- and post-EA treatment.
- To assess the safety and feasibility of administering EA to manage symptom clusters in cancer patients and survivors.
- As the UCI MINDS C2C registry (UCI IRB Approval #: HS# 2015-2494) will be leveraged to recruit some patients, we will quantify the characteristics associated with non-response to our study advertisement among C2C registrants using C2C-collected data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized sham-controlled, patient and assessor-blinded pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: ElectroacupunctureEach participant will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Each EA session will be approximately 1 hour. Participants in the treatment arm will receive EA at 13 standardized acu-points that were chosen for their therapeutic effects. |
| Control Arm | Sham comparator | Other: Sham-ElectroacupunctureEach participant in the control arm will attend a total of 10 treatment visits (one visit per week), over the course of 10 weeks. Participants in the control arm will receive electrical stimulation at non-disease related acu-points for approximately 1 hour per session. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with cancer that have received anti-cancer treatment
- 16 years of age or older
- Life expectancy ≥ 6 months
- Complaints of one or more of the following symptoms: memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past 7 days
Key exclusion criteria (10 listed)
- Presence of metastasis
- Severe needle phobia
- Severe psychiatric or medical disorders which would affect cognitive assessments
- Known bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
- Has pacemaker or other electronic metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureEA at 13 standardized acu-points that were chosen for their therapeutic effects: Shenting (GV24), Baihui (DU20), Sinshencong (EX-HN1), Zhongwan (CV12), Guanyuan (CV4), Neiguan (PC6) bilateral, Shenmen (HT7) bilateral, Zusanli (ST36) bilateral, Sanyinjiao (SP6) bilateral, Taixi (KI3) bilateral, Zhaohai (KI6) bilateral, Hegu (LI4) bilateral, Taichong (LIV3) bilateral | Other | Treatment Arm |
| Sham-ElectroacupunctureNon-disease related points with electrical stimulation: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Fuyang (BL59) bilateral, Kunlun (BL60) bilateral, Sanyangluo (TE8), Sidu (TE9) bilateral, Daheng (SP15) bilateral | Other | Control Arm |
Primary outcome
Subjective Cognitive Function (FACT-Cog version 3)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
All subjects will complete the FACT-Cog version 3 questionnaire to assess self-perceived subjective cognitive function. FACT-Cog is a validated questionnaire containing 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning.
25 secondary outcomes
Objective Cognitive Function (CANTAB®,)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Fatigue (MFSI-SF)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Psychological Distress and Insomnia (RSCL)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Quality of Life (EORTC QLQ-30)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Quality of Life (EQ-5D-5L)
Time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Safety Monitoring
Time frame: Through study completion, an average of 14 weeks per participant.
Biomarkers - Plasma BDNF (pg/ml)
Time frame: BDNF levels will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Plasma cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-alpha, pg/mL)
Time frame: Cytokine levels will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Mitochondrial DNA content
Time frame: mtDNA content will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.
Biomarkers - Gray matter volume
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - White matter volume
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Mean diffusivity
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Fractional anisotropy
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Radial diffusivities
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Axial diffusivities
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Biomarkers - Resting state functional connectivities
Time frame: Neuroimaging measures will be compared before acupuncture and 10 weeks after baseline for EA and sham-EA control groups. The changes will also be compared between the EA and sham-EA control groups at 10 weeks after baseline.
Feasibility - Recruitment (number of participants recruited)
Time frame: Through study completion, approximately 2 years.
Feasibility - Recruitment (rate of recruitment)
Time frame: Through study completion, approximately 2 years.
Feasibility - Recruitment (reasons for declining participation)
Time frame: Through study completion, approximately 2 years.
Feasibility - Recruitment (time spent on recruitment)
Time frame: Through study completion, approximately 2 years.
Feasibility - Compliance (number of acupuncture sessions successfully completed)
Time frame: Through study completion, approximately 2 years.
Feasibility - Compliance (proportion of participants completing the scheduled acupuncture sessions)
Time frame: Through study completion, approximately 2 years.
Feasibility - Acceptability
Time frame: Upon completion of treatment, at 10 weeks from baseline.
Feasibility - Satisfaction
Time frame: Upon completion of treatment, at 10 weeks from baseline.
Feasibility - Blinding assessment
Time frame: Upon completion of treatment, at 10 weeks from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 28029304Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
- Background: PubMed 29315963Ng T, Dorajoo SR, Cheung YT, Lam YC, Yeo HL, Shwe M, Gan YX, Foo KM, Loh WK, Koo SL, Jain A, Lee GE, Dent R, Yap YS, Ng R, Chan A. Distinct and heterogeneous trajectories of self-perceived cognitive impairment among Asian breast cancer survivors. Psychooncology. 2018 Apr;27(4):1185-1192. doi: 10.1002/pon.4635. Epub 2018 Feb 1.
- Background: PubMed 25922060Cheung YT, Ng T, Shwe M, Ho HK, Foo KM, Cham MT, Lee JA, Fan G, Tan YP, Yong WS, Madhukumar P, Loo SK, Ang SF, Wong M, Chay WY, Ooi WS, Dent RA, Yap YS, Ng R, Chan A. Association of proinflammatory cytokines and chemotherapy-associated cognitive impairment in breast cancer patients: a multi-centered, prospective, cohort study. Ann Oncol. 2015 Jul;26(7):1446-51. doi: 10.1093/annonc/mdv206. Epub 2015 Apr 28.
- Background: PubMed 31016867Toh YL, Tan CJ, Yeo AHL, Shwe M, Ho HK, Gan YX, Foo KM, Chu P, Olson K, Chan A. Association of plasma leptin, pro-inflammatory adipokines and cancer-related fatigue in early-stage breast cancer patients: A prospective cohort study. J Cell Mol Med. 2019 Jun;23(6):4281-4289. doi: 10.1111/jcmm.14319. Epub 2019 Apr 23.
- Background: PubMed 23249868Cheung YT, Shwe M, Chui WK, Chay WY, Ang SF, Dent RA, Yap YS, Lo SK, Ng RC, Chan A. Effects of chemotherapy and psychosocial distress on perceived cognitive disturbances in Asian breast cancer patients. Ann Pharmacother. 2012 Dec;46(12):1645-55. doi: 10.1345/aph.1R408. Epub 2012 Dec 18.
- Background: PubMed 32320061Liou KT, Root JC, Garland SN, Green J, Li Y, Li QS, Kantoff PW, Ahles TA, Mao JJ. Effects of acupuncture versus cognitive behavioral therapy on cognitive function in cancer survivors with insomnia: A secondary analysis of a randomized clinical trial. Cancer. 2020 Jul 1;126(13):3042-3052. doi: 10.1002/cncr.32847. Epub 2020 Apr 22.
- Background: PubMed 32305573Zhang ZJ, Man SC, Yam LL, Yiu CY, Leung RC, Qin ZS, Chan KS, Lee VHF, Kwong A, Yeung WF, So WKW, Ho LM, Dong YY. Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Brain Behav Immun. 2020 Aug;88:88-96. doi: 10.1016/j.bbi.2020.04.035. Epub 2020 Apr 16.
- Background: PubMed 29735975Tong T, Pei C, Chen J, Lv Q, Zhang F, Cheng Z. Efficacy of Acupuncture Therapy for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients. Med Sci Monit. 2018 May 8;24:2919-2927. doi: 10.12659/MSM.909712.
- Background: PubMed 29806502Zeng Y, Cheng ASK, Song T, Sheng X, Wang S, Xie J, Chan CCH. Effects of Acupuncture on Cancer-Related Cognitive Impairment in Chinese Gynecological Cancer Patients: A Pilot Cohort Study. Integr Cancer Ther. 2018 Sep;17(3):737-746. doi: 10.1177/1534735418777109. Epub 2018 May 26.
- Derived from this study: PubMed 41926740Ng DQ, Heshmatipour M, Trudeau J, Sridhar A, Pluimer B, Drayson OGG, Lavasani SM, Parajuli R, Lee S, Agrawal A, Acharya MM, Limoli CL, Harris RE, Xie L, Malik S, Chan A. Electroacupuncture improves cognitive function and neuropsychiatric symptoms in breast cancer survivors: a pilot randomized controlled trial. J Natl Cancer Inst. 2026 Apr 2:djag096. doi: 10.1093/jnci/djag096. Online ahead of print.
- Derived from this study: PubMed 36973688Xie L, Ng DQ, Heshmatipour M, Acharya M, Coluzzi P, Guerrero N, Lee S, Malik S, Parajuli R, Stark C, Tain R, Zabokrtsky K, Torno L, Chan A. Electroacupuncture for the management of symptom clusters in cancer patients and survivors (EAST). BMC Complement Med Ther. 2023 Mar 27;23(1):92. doi: 10.1186/s12906-023-03926-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Chan, PharmD principal investigator
UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive Function (FACT-Cog version 3) (time frame: All the mean scores will be compared before acupuncture and 5, 10 and 14 weeks after baseline for EA and sham-EA control groups. The mean score changes will also be compared between the EA and sham-EA control groups at 5, 10 and 14 weeks after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283577, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.