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Insomnia, SecondaryBCINCT04144309

Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

A study testing Electroacupuncture (EA) and Auricular Acupressure (AA) in people with Insomnia, Secondary and Breast Cancer Female, run by The University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II)… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Electroacupuncture (EA) and Auricular Acupressure (AA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
2 sitesHong Kong
Study dates
18 Nov 2019to 30 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients between 18 and 75 years of age.
  • Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer.
  • Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months.
  • Insomnia onset after the diagnosis of breast cancer.
  • Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks.
  • Expected survival time of more than 6 months.
  • Ability to understand the nature of the study and willingness to give informed consent.
  • Ability to provide responses during outcome measurement.

Who cannot join

  • Other sleep disorder (e.g., obstructive sleep apnoea).
  • Shift work or irregular sleep pattern.
  • Severe visual, hearing or language defects.
  • Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL).
  • History of acupuncture use in the previous 3 months.
  • Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Department of Clinical Oncology, Queen Mary Hospital

    Hong Kong, 999077

  • Hong Kong Sanatorium & Hospital

    Hong Kong, 999077

Other trials in Hong Kong

About this study

Official title: The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial

The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.

Read the detailed description

Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments are lacking.

Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy.

Hypothesis: We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control.

Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment.

Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.

Being tested
Electroacupuncture (EA) and Auricular Acupressure (AA), Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)
Keywords
Acupuncture, Insomnia, Breast cancer, Chemotherapy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture (EA) and Auricular Acupressure (AA)Procedure or surgery

    EA: Ten points will be used, including GV24 (Shenting), GV20 (Baihui), EX-HN1 (Sishenchong), PC6 (Neiguan), CV12 (Zhongwan), CV4 (Guanyuan), ST25 (Tianshu), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi).

    AA: Vaccaria seeds will be embedded by acupuncturists on three auricular points (Shenmen, Sympathetic and Heart) and maintained between EA treatments.

  • Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)Procedure or surgery

    SE: The sham acupuncture treatment procedure, including the acupoint selection principle, sterilization procedure and treatment schedule, will be the same as in the acupuncture treatment group, except that sham points 1 to 2 cm exterior and inferior to the real points will be used, and no needle penetration or electric stimulation will be performed.

    SA: Three sham auricular points in the helix region (HX7, HX8, HX9) will be selected. Instead of Vaccaria seeds, soft Junci Medulla (1 to 2 mm in length, dyed black) will be used to mimic real AA with no pressure.

Study groups in NCT04144309
Study groupRoleWhat they receive
True acupuncture groupActive comparator12 sessions of acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
Receives: Procedure: Electroacupuncture (EA) and Auricular Acupressure (AA)
Sham acupuncture groupPlacebo comparator12 sessions of sham acupuncture treatment (SE+SA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
Receives: Procedure: Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity Index (ISI)

    The primary outcome will be the change of ISI score between the baseline and the end of the 6-week treatment. The ISI is a seven-item questionnaire devised to diagnose and assess the severity of insomnia.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

Secondary outcomes (7)

  1. Actiwatch

    The subjects will wear Actiwatch for 1 week at baseline period and the end of 6-week treatment.

    Measured: Baseline, 6 week.

  2. Sleep diary

    Subjects will be given daily sleep diary for 1 week at baseline period and the end of 6-week treatment.

    Measured: Baseline, 6 week.

  3. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a reliable and valid self-reported questionnaire that assesses sleep quality over 1 month.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

  4. Hospital Anxiety and Depression Scale (HADS)

    The HADS, a 14-item self-rated questionnaire, evaluates the severity of depressive and anxiety symptoms.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

  5. Brief Pain Inventory-Short Form (BPI-SF)

    The BFI is a brief screening tool designed to assess the severity and impact of cancer-related fatigue on daily functioning.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

  6. Brief Fatigue Inventory (BPI)

    The BPI is a self-administered questionnaire designed to assess cancer pain.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

  7. Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)

    The FACT-B is a patient-reported outcome measure used to assess health-related quality of life in breast cancer patients.

    Measured: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start18 Nov 2019
  3. Primary completion30 Jan 2022
  4. Study completion30 Jul 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144309
Sponsor's protocol ID
UW 19-045
Acronym
BCI
Status last verified
May 2024
First submitted
28 Oct 2019
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.

    PubMed 21825267

  • Savard J, Villa J, Ivers H, Simard S, Morin CM. Prevalence, natural course, and risk factors of insomnia comorbid with cancer over a 2-month period. J Clin Oncol. 2009 Nov 1;27(31):5233-9. doi: 10.1200/JCO.2008.21.6333. Epub 2009 Sep 8.

    PubMed 19738124

  • Savard J, Ivers H, Savard MH, Morin CM. Cancer treatments and their side effects are associated with aggravation of insomnia: Results of a longitudinal study. Cancer. 2015 May 15;121(10):1703-11. doi: 10.1002/cncr.29244. Epub 2015 Feb 11.

    PubMed 25677509

  • Fakih R, Rahal M, Hilal L, Hamieh L, Dany M, Karam S, Shehab L, El Saghir NS, Tfayli A, Salem Z, Assi H, Temraz S, Shamseddine A, Mukherji D. Prevalence and Severity of Sleep Disturbances among Patients with Early Breast Cancer. Indian J Palliat Care. 2018 Jan-Mar;24(1):35-38. doi: 10.4103/IJPC.IJPC_137_17.

    PubMed 29440804

  • Dahiya S, Ahluwalia MS, Walia HK. Sleep disturbances in cancer patients: underrecognized and undertreated. Cleve Clin J Med. 2013 Nov;80(11):722-32. doi: 10.3949/ccjm.80a.12170.

    PubMed 24186891

  • Cash E, Sephton SE, Chagpar AB, Spiegel D, Rebholz WN, Zimmaro LA, Tillie JM, Dhabhar FS. Circadian disruption and biomarkers of tumor progression in breast cancer patients awaiting surgery. Brain Behav Immun. 2015 Aug;48:102-14. doi: 10.1016/j.bbi.2015.02.017. Epub 2015 Feb 26.

    PubMed 25728235

  • Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895.

    PubMed 11157043

  • Krystal AD. The changing perspective on chronic insomnia management. J Clin Psychiatry. 2004;65 Suppl 8:20-5.

    PubMed 15153064

  • Leung GM, Thach TQ, Lam TH, Hedley AJ, Foo W, Fielding R, Yip PS, Lau EM, Wong CM. Trends in breast cancer incidence in Hong Kong between 1973 and 1999: an age-period-cohort analysis. Br J Cancer. 2002 Oct 21;87(9):982-8. doi: 10.1038/sj.bjc.6600583.

    PubMed 12434289

  • Bergdahl L, Broman JE, Berman AH, Haglund K, von Knorring L, Markstrom A. Sleep patterns in a randomized controlled trial of auricular acupuncture and cognitive behavioral therapy for insomnia. Complement Ther Clin Pract. 2017 Aug;28:220-226. doi: 10.1016/j.ctcp.2017.06.006. Epub 2017 Jun 30.

    PubMed 28779933

  • Zia FZ, Olaku O, Bao T, Berger A, Deng G, Fan AY, Garcia MK, Herman PM, Kaptchuk TJ, Ladas EJ, Langevin HM, Lao L, Lu W, Napadow V, Niemtzow RC, Vickers AJ, Shelley Wang X, Witt CM, Mao JJ. The National Cancer Institute's Conference on Acupuncture for Symptom Management in Oncology: State of the Science, Evidence, and Research Gaps. J Natl Cancer Inst Monogr. 2017 Nov 1;2017(52):lgx005. doi: 10.1093/jncimonographs/lgx005.

    PubMed 29140486

  • Garland SN, Gehrman P, Barg FK, Xie SX, Mao JJ. CHoosing Options for Insomnia in Cancer Effectively (CHOICE): Design of a patient centered comparative effectiveness trial of acupuncture and cognitive behavior therapy for insomnia. Contemp Clin Trials. 2016 Mar;47:349-55. doi: 10.1016/j.cct.2016.02.010. Epub 2016 Mar 5.

    PubMed 26956541

  • Bao T, Goloubeva O, Pelser C, Porter N, Primrose J, Hester L, Sadowska M, Lapidus R, Medeiros M, Lao L, Dorsey SG, Badros AZ. A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integr Cancer Ther. 2014 Sep;13(5):396-404. doi: 10.1177/1534735414534729. Epub 2014 May 26.

    PubMed 24867959

  • Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009 Aug;32(8):1039-47. doi: 10.1093/sleep/32.8.1039.

    PubMed 19725255

  • Yeung WF, Chung KF, Leung YK, Zhang SP, Law AC. Traditional needle acupuncture treatment for insomnia: a systematic review of randomized controlled trials. Sleep Med. 2009 Aug;10(7):694-704. doi: 10.1016/j.sleep.2008.08.012. Epub 2009 Mar 19.

    PubMed 19303356

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture (EA) and Auricular Acupressure (AA) in people with Insomnia, Secondary and Breast Cancer Female, run by The University of Hong Kong at 2 sites in Hong Kong.

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 8 inclusion and 6 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: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Insomnia Severity Index (ISI) (time frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.). 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 NCT04144309, which also lists 23 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 17 May 2024.

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