Gynaecological, Urological or Rectal CancerAcuCINNCT06769061
The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy in Gynaecological Cancer Patients
A study testing Acupuncture in people with Gynaecological, Urological or Rectal Cancer and Chemotherapy-Induced Peripheral Neuropathy, run by Karen Kar Loen CHAN at 1 site in Hong Kong.
Trial summary
Objectives: To explore the feasibility and effectiveness of acupuncture on reducing Chemotherapy Induced Peripheral Neuropathy (CIPN) in gynaecological cancer patients who have received carboplatin and paclitaxel chemotherapy combination. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological, Urological or Rectal Cancer, Chemotherapy-Induced Peripheral Neuropathy, Acupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Feb 2025to Dec 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Diagnosis of uterine (endometrial) cancer, ovarian cancer and cervical cancer
- ECOG=0-2
- Life expectancy of > 6 months
- Completed at least 6 cycles of carboplatin or cisplatin chemotherapy together with paclitaxel at least 3 months before joining the study
- Able to read and understand the questionnaires
- PNQ score of C or above
Who cannot join
- Bleeding tendency
- Abnormal clotting profile
- Platelet lower than 50
- Received acupuncture in the past
- Currently receiving chemotherapy treatment
- Known neurological disorders or pre-existing neuropathy unrelated to chemotherapy
Show all 9Show fewer
- Routinely take aspirin or any anticoagulant drugs
- Having active skin infection
- With pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology
Hong Kong
Karen Kar Loen CHAN, MBBChir (Cantab); MD (HK), 852-22554265, kklchan@hku.hk
Tina WEI, PhD, 852-22554265, tinawei@hku.hk
About this study
Official title: The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial
Objectives:
To explore the feasibility and effectiveness of acupuncture on reducing Chemotherapy Induced Peripheral Neuropathy (CIPN) in gynaecological cancer patients who have received carboplatin and paclitaxel chemotherapy combination. Results of this pilot trial will provide preliminary information for a potential a larger scale multicentre study.
Read more
Hypothesis:
Acupuncture can significantly reduce CIPN in gynaecological cancer patients treated with chemotherapy
Design and subjects:
This is a pilot, prospective randomised controlled trial. This is an exploratory trial to evaluate the feasibility and effectiveness of acupuncture in reducing CIPN in gynaecological cancer patients. Eligible patients will be 1:1:1 randomised to three groups: electroacupuncture group, sham acupuncture group and waiting-list (usual care) control group. For electroacupuncture and sham acupuncture groups, the assessors and the patients will be blinded to the treatment given.
- Electroacupuncture group - patients will receive 6 weeks of electroacupuncture, 2 sessions per week, by a qualified Traditional Chinese Medicine practitioner from the School of Chinese Medicine.
- Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above.
- Waiting-list (usual care) control group - patients will not receive any treatment.
Main outcomes:
Acupuncture effects will be assessed at baseline and 3, 6,12 weeks post intervention by:
- Patient reported outcome measures: FACT/GOG-Ntx questionnaire for assessing CIPN symptoms and EORTC-QLQ-C30 and CIPN20 questionnaires for assessing quality of life symptom
- Clinician reported outcome measures: NCI-CTCAE grading for CIPN by clinicians and Semmes-Weinstein monofilament test as an objective measurement of CIPN.
Data analysis:
Intention to treat analysis will be carried out. Baseline demographics will be compared between the 3 groups. Change from baseline total score will be calculated and analysed using 2-sample t-test. 95% CI will be reported for treatment differences. Score for different subcategories will be analysed in a similar manner. Data collected at week 6 will be used for outcome analysis. P<0.05 will be considered as statistically significant. Acupuncture efficacy, effectiveness and placebo effect will be indicated by comparison of acupuncture vs. sham acupuncture, acupuncture vs. waiting-list, and sham acupuncture vs. waiting-list, respectively.
Expected results: Patients in the acupuncture arm will have reduced numbness and peripheral neuropathy and improved quality of life without any adverse event.
Read the detailed description
Subjects will be recruited by research assistant at the gynaecological oncology clinics at Queen Mary Hospital. All potential subjects will be required to fill in a screening questionnaire to assess the degree of neuropathy. Screening blood test (Complete blood picture) will be taken within 1 month of starting acupuncture. Eligible subjects will be enrolled into the study according to the inclusion and exclusion criteria. Any type of acupuncture or message in daily Traditional Chinese Medicine clinic will be prohibited during the trial once the subject is enrolled.
Subjects will be allocated to the 3 groups through computer generated randomization: acupuncture, sham acupuncture or the waiting-list (usual care) control group on a 1:1:1 ratio. Allocations will be kept within sealed opaque envelopes. Once a patient has been enrolled, an envelope is opened and the patient is then offered the allocated treatment regimen. Both the subjects (acupuncture and sham acupuncture group) and the gynaecological clinical research team responsible for the clinical care and neuropathy assessments will be blinded to the results.
Patients who are randomised to sham acupuncture or waiting-list control group will be offered the option of receiving 12 acupuncture treatments when they finish all study procedures.
- Conditions
- Gynaecological, Urological or Rectal Cancer, Chemotherapy-Induced Peripheral Neuropathy, Acupuncture
- Being tested
- Acupuncture, sham acupuncture
- Keywords
- Gynaecological Cancer, Acupuncture, Chemotherapy induced peripheral neuropathy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Patients will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session Stainless steel, single-use, sterile, and disposable needles will be used. We will use the bilateral acupoints LI4 (He-Gu), TE5 (Wai-Guan), LI11 (Qu-Chi), and LU5 (Chi-Ze) for upper limbs. For lower limb numbness, we will use the bilateral acupoints of LV3 (Tai-Chong), ST41 (Jie-Xi), SP6 (San-Yin-Jiao), and GB34 (Yang-Ling-Quan) for the numbness of back of feet, or the bilateral acupoints of KI1 (Yong-Quan), KI3 (Tai-Xi), SP6 (San-Yin-Jiao), and GB34 (Yang-Ling-Quan). After skin disinfection, sterile adhesive pads will be placed on bilateral LI4 (Hegu), TE5 (Waiguan), LI11 (Quchi), and LU5 (Chize). Following each needle insertion, acupuncturists will perform equal manipulations of twirling, lifting, and thrusting on the needle by acupuncturists to achieve the de qi sensation. These 4 acupoints (He-Gu, Qu-Chi, San-Yin-Jiao, Yang-Ling-Quan) will be electrically stimulated for 30 min.
sham acupunctureDevice
Patients will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session. The Streitberger sham acupuncture needle designed specifically for sham acupuncture trials will be used. Patients will feel the needle on the skin, but the needle actually will not puncture the skin. These 4 acupoints (He-Gu, Qu-Chi, San-Yin-Jiao, Yang-Ling-Quan) will be connected to the electrical stimulation device KWD-808I MULTI-PURPOSE Health device (Great Wall Company), but not stimulated. The needle will remain for 30 minutes. without stimulating the acupoints. The sham acupuncture will be used within the trocar. The trocar will be fixed by a base on the skin with sticker. The trocar-base-sticker will be used for both acupuncture group and sham acupuncture control group, so they are exactly the same in appearance. Patients cannot see if there is acupuncture or sham acupuncture within the trocar.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Patients randomised to this arm will receive intervention of electroacupuncture. They will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session. Receives: Procedure: Acupuncture |
| Sham acupuncture | Sham comparator | Patients randomised to this arm will receive sham comparator, sham acupuncture. They will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session. Receives: Device: sham acupuncture |
| Waiting-list (usual care) control | No intervention | Patients randomised to the waiting-list control group will receive standard of care managementf for CIPN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Induced Peripheral Neuropathy associated quality of life measured by Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-NTX) total score
This questionnaire provides a targeted assessment of peripheral neuropathy symptoms. It consists of a total of 38 items on physical, social, emotional and functioning well-being with 11 questions focusing on neurotoxicity. This instrument is validated and has been used in Phase 3 clinical trials. The higher the score, the better the quality of life.
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
Secondary outcomes (8)
The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-C30 (EORTC-QLQ-C30) questionnaires
Quality of life will be assessed by patient reported EORTC-QLQ-C30 questionnaires): C30 is a well validated instrument to assess quality of life in cancer patients. It consists of 30 items encompassing physical, emotional, social and functional aspects. Higher scores indicate better quality of life
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN20) questionnaires
Quality of life will be assessed by patient reported EORTC-QLQ-CIPN20 questionnaires: CIPN20 is a 20 items additional module to EORTC-QLQ-C30 focusing on Chemotherapy Induced Peripheral Neuropathy symptoms. Higher scores indicate better quality of life
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the changes in light touch sensation by Semmes-Weinstein filaments test
For assessment the light touch sensation, the research assistant will perform Semmes-Weinstein filaments (SWM) test at the same time points as the patient's questionnaires (Baseline, Week 3, 6, 12). Each monofilament will be used for three consecutive times on the same point, and the participants are asked to provide information about their sense of touch with their eyes closed. The testing session starts using the thinnest monofilament, moving to a thicker one if the participant does not feel a monofilament.
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the safety by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading
Any adverse effects and their severity during treatment procedures including dizziness, nausea, vomiting, pain, discomfort, sweating, palpitations, bleeding and bruising will be assessed by CTCAE. The intervention will be discontinued if patients suffer from any serious adverse events (AEs). AE will be managed according to standard of care procedures.
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the chemotherapy induced peripheral pain in numeric rating scale
Numeric rating scale represents a key element for measuring pain intensity and symptomatology. It ranges from 0 to 10. 0 means no pain and 10 means maximum pain.
Measured: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
Explore the acupuncture expectancy by Acupuncture expectancy scale (for acupuncture and sham acupuncture group)
In order to control the bias from placebo effect of acupuncture, acupuncture expectance scale will be used to measure the patients' expectations of positive outcomes from the treatment. It is a validated measurement with four items, with score ranging from 4 to 20
Measured: At baseline and week 3 (after receiving treatment for 3 weeks)
Explore the acupuncture credibility by Acupuncture credibility questionnaire (for acupuncture and sham acupuncture group)
Acupuncture credibility questionnaire is a questionnaire to control the bias from different patients' credibility of acupuncture practitioners. It is a validated assessment including 4 questions with score ranging from 0 to 6. 0 means minimum and 6 means maximum agreement of the item
Measured: At week 3 (after receiving treatment for 3 weeks)
Changes in inflammatory biomarkers
Changes in inflammatory biomarkers after acupuncture will be explored. The BD cytometric Bead Array system (CBA) will be used to quantify the level of inflammation panel (IL10, IL12-p70, IL1β, IL6), Th1/Th2 panel (IL2, IL4, IL5, TNF, IFNγ), B cell activation panel (CD79b, BLNK, Btk, Syk, PLCγ), T cell activation panel (TCRz, SLP-76, ZAP70, Pyk2, Itk), and the Complements panel (C4a, C3a, C5a). The plasma level of CRP will be determined by ELISA assay. Fecal samples will be sent for fecal sequencing and profiling to explore the potential mechanisms of acupuncture effects.
Measured: From enrollment to end of treatment including: baseline at enrollment, after 6 weeks of treatment (end of treatment)/ enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start12 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological, Urological or Rectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be 1:1:1 randomised to three groups: electroacupuncture group, sham acupuncture group and waiting-list (usual care) control group. For electroacupuncture and sham acupuncture groups, the assessors and the patients will be blinded to the treatment given. 1. Electroacupuncture group - patients will receive 6 weeks of electroacupuncture, 2 sessions per week, by a qualified TCM practitioner from the School of Chinese Medicine. 2. Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above. 3. Waiting-list (usual care) control group - patients will not receive any treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen Kar Loen CHAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Kar Loen CHAN, The University of Hong Kong
- Investigators
- Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK), Principal investigator, Department of Obstetrics and Gynaecology, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769061
- Sponsor's protocol ID
- AcuCIN
- Acronym
- AcuCIN
- Status last verified
- Feb 2026
- First submitted
- 20 Dec 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy (CIPN) in Gynaecological Cancer Patients - A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06769061
- Acronym / sponsor ID
- AcuCIN / AcuCIN
- Conditions
- Gynaecological, Urological or Rectal Cancer, Chemotherapy-Induced Peripheral Neuropathy, Acupuncture
- Keywords
- Gynaecological Cancer, Acupuncture, Chemotherapy induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Karen Kar Loen CHANUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
Objectives:
To explore the feasibility and effectiveness of acupuncture on reducing Chemotherapy Induced Peripheral Neuropathy (CIPN) in gynaecological cancer patients who have received carboplatin and paclitaxel chemotherapy combination. Results of this pilot trial will provide preliminary information for a potential a larger scale multicentre study.
Hypothesis:
Acupuncture can significantly reduce CIPN in gynaecological cancer patients treated with chemotherapy
Design and subjects:
This is a pilot, prospective randomised controlled trial. This is an exploratory trial to evaluate the feasibility and effectiveness of acupuncture in reducing CIPN in gynaecological cancer patients. Eligible patients will be 1:1:1 randomised to three groups: electroacupuncture group, sham acupuncture group and waiting-list (usual care) control group. For electroacupuncture and sham acupuncture groups, the assessors and the patients will be blinded to the treatment given.
- Electroacupuncture group - patients will receive 6 weeks of electroacupuncture, 2 sessions per week, by a qualified Traditional Chinese Medicine practitioner from the School of Chinese Medicine.
- Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above.
- Waiting-list (usual care) control group - patients will not receive any treatment.
Main outcomes:
Acupuncture effects will be assessed at baseline and 3, 6,12 weeks post intervention by:
- Patient reported outcome measures: FACT/GOG-Ntx questionnaire for assessing CIPN symptoms and EORTC-QLQ-C30 and CIPN20 questionnaires for assessing quality of life symptom
- Clinician reported outcome measures: NCI-CTCAE grading for CIPN by clinicians and Semmes-Weinstein monofilament test as an objective measurement of CIPN.
Data analysis:
Intention to treat analysis will be carried out. Baseline demographics will be compared between the 3 groups. Change from baseline total score will be calculated and analysed using 2-sample t-test. 95% CI will be reported for treatment differences. Score for different subcategories will be analysed in a similar manner. Data collected at week 6 will be used for outcome analysis. P<0.05 will be considered as statistically significant. Acupuncture efficacy, effectiveness and placebo effect will be indicated by comparison of acupuncture vs. sham acupuncture, acupuncture vs. waiting-list, and sham acupuncture vs. waiting-list, respectively.
Expected results: Patients in the acupuncture arm will have reduced numbness and peripheral neuropathy and improved quality of life without any adverse event.
Detailed description
Subjects will be recruited by research assistant at the gynaecological oncology clinics at Queen Mary Hospital. All potential subjects will be required to fill in a screening questionnaire to assess the degree of neuropathy. Screening blood test (Complete blood picture) will be taken within 1 month of starting acupuncture. Eligible subjects will be enrolled into the study according to the inclusion and exclusion criteria. Any type of acupuncture or message in daily Traditional Chinese Medicine clinic will be prohibited during the trial once the subject is enrolled.
Subjects will be allocated to the 3 groups through computer generated randomization: acupuncture, sham acupuncture or the waiting-list (usual care) control group on a 1:1:1 ratio. Allocations will be kept within sealed opaque envelopes. Once a patient has been enrolled, an envelope is opened and the patient is then offered the allocated treatment regimen. Both the subjects (acupuncture and sham acupuncture group) and the gynaecological clinical research team responsible for the clinical care and neuropathy assessments will be blinded to the results.
Patients who are randomised to sham acupuncture or waiting-list control group will be offered the option of receiving 12 acupuncture treatments when they finish all study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible patients will be 1:1:1 randomised to three groups: electroacupuncture group, sham acupuncture group and waiting-list (usual care) control group. For electroacupuncture and sham acupuncture groups, the assessors and the patients will be blinded to the treatment given. 1. Electroacupuncture group - patients will receive 6 weeks of electroacupuncture, 2 sessions per week, by a qualified TCM practitioner from the School of Chinese Medicine. 2. Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above. 3. Waiting-list (usual care) control group - patients will not receive any treatment.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupuncturePatients randomised to this arm will receive intervention of electroacupuncture. They will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session. |
| Sham acupuncture | Sham comparator | Device: sham acupuncturePatients randomised to this arm will receive sham comparator, sham acupuncture. They will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session. |
| Waiting-list (usual care) control | No intervention | –Patients randomised to the waiting-list control group will receive standard of care managementf for CIPN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or above
- Diagnosis of uterine (endometrial) cancer, ovarian cancer and cervical cancer
- ECOG=0-2
- Life expectancy of > 6 months
- Completed at least 6 cycles of carboplatin or cisplatin chemotherapy together with paclitaxel at least 3 months before joining the study
Key exclusion criteria (9 listed)
- Bleeding tendency
- Abnormal clotting profile
- Platelet lower than 50
- Received acupuncture in the past
- Currently receiving chemotherapy treatment
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 |
|---|---|---|
| AcupuncturePatients will receive 6 weeks of electroacupuncture, 2 sessions per week, 30 min per session Stainless steel, single-use, sterile, and disposable needles will be used. We will use the bilateral acupoints LI4 (He-Gu), TE5 (Wai-Guan), LI11 (Qu-Chi), and LU5 (Chi-Ze) for upper limbs. For lower limb numbness, we will use the bilateral acupoints of LV3 (Tai-Chong), ST41 (Jie-Xi), SP6 (San-Yin-Jiao), and GB34 (Yang-Ling-Quan) for the numbness of back of feet, or the bilateral acupoints of KI1 (Yong-Quan), KI3 (Tai-Xi), SP6 (San-Yin-Jiao), and GB34 (Yang-Ling-Quan). After skin disinfection, sterile adhesive pads will be placed on bilateral LI4 (Hegu), TE5 (Waiguan), LI11 (Quchi), and LU5 (Chize). Following each needle insertion, acupuncturists will perform equal manipulations of twirling, lifting, and thrusting on the needle by acupuncturists to achieve the de qi sensation. These 4 acupoints (He-Gu, Qu-Chi, San-Yin-Jiao, Yang-Ling-Quan) will be electrically stimulated for 30 min. | Procedure or surgery | Acupuncture |
| sham acupuncturePatients will receive 6 weeks of sham acupuncture, 2 sessions per week, 30 min per session. The Streitberger sham acupuncture needle designed specifically for sham acupuncture trials will be used. Patients will feel the needle on the skin, but the needle actually will not puncture the skin. These 4 acupoints (He-Gu, Qu-Chi, San-Yin-Jiao, Yang-Ling-Quan) will be connected to the electrical stimulation device KWD-808I MULTI-PURPOSE Health device (Great Wall Company), but not stimulated. The needle will remain for 30 minutes. without stimulating the acupoints. The sham acupuncture will be used within the trocar. The trocar will be fixed by a base on the skin with sticker. The trocar-base-sticker will be used for both acupuncture group and sham acupuncture control group, so they are exactly the same in appearance. Patients cannot see if there is acupuncture or sham acupuncture within the trocar. | Device | Sham acupuncture |
Primary outcome
Chemotherapy Induced Peripheral Neuropathy associated quality of life measured by Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-NTX) total score
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
This questionnaire provides a targeted assessment of peripheral neuropathy symptoms. It consists of a total of 38 items on physical, social, emotional and functioning well-being with 11 questions focusing on neurotoxicity. This instrument is validated and has been used in Phase 3 clinical trials. The higher the score, the better the quality of life.
8 secondary outcomes
The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-C30 (EORTC-QLQ-C30) questionnaires
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
The changes in quality of life assessed by European Organisation For Research And Treatment Of Cancer-Quality of Life-Chemotherapy Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN20) questionnaires
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the changes in light touch sensation by Semmes-Weinstein filaments test
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the safety by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
assess the chemotherapy induced peripheral pain in numeric rating scale
Time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment
Explore the acupuncture expectancy by Acupuncture expectancy scale (for acupuncture and sham acupuncture group)
Time frame: At baseline and week 3 (after receiving treatment for 3 weeks)
Explore the acupuncture credibility by Acupuncture credibility questionnaire (for acupuncture and sham acupuncture group)
Time frame: At week 3 (after receiving treatment for 3 weeks)
Changes in inflammatory biomarkers
Time frame: From enrollment to end of treatment including: baseline at enrollment, after 6 weeks of treatment (end of treatment)/ enrollment
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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.
Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK) principal investigator
Department of Obstetrics and Gynaecology, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Gynaecological, Urological or Rectal Cancer and Chemotherapy-Induced Peripheral Neuropathy, run by Karen Kar Loen CHAN at 1 site 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Feb 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 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?
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?
Contact Karen Kar Loen CHAN, MBBChir (Cantab); MD (HK) (852-2255 4265, kklchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy Induced Peripheral Neuropathy associated quality of life measured by Functional Assessment of Cancer Therapy / Gynecologic Oncology Group - Neurotoxicity subscale (FACT/GOG-NTX) total score (time frame: From enrollment to 6 weeks after end of treatment including: baseline at enrollment, after 3 weeks of treatment/enrollment, after 6 weeks of treatment (end of treatment)/ enrollment, and 6 weeks after end of treatment /12 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.