The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy in Gynaecological Cancer Patients

NCT06769061 | Recruiting DMC

• 1 other identifier: AcuCIN
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

1. 1.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.
2. 2.Sham acupuncture group - patients will receive 6 weeks of sham acupuncture similar to the above.
3. 3.Waiting-list (usual care) control group - patients will not receive any treatment.
4. 4.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
5. 5.Clinician reported outcome measures: NCI-CTCAE grading for CIPN by clinicians and Semmes-Weinstein monofilament test as an objective measurement of CIPN.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Acupuncture; Gynaecological, Urological or Rectal Cancer

Keywords

Gynaecological Cancer; Acupuncture; Chemotherapy induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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

Study Arms (3)

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.

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.

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.

Interventions

Acupuncture PROCEDURE

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.

Acupuncture

sham acupuncture DEVICE

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.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Routinely take aspirin or any anticoagulant drugs
• Having active skin infection
• With pacemaker

Sponsors & Collaborators

• Karen Kar Loen CHAN: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK)

  Department of Obstetrics and Gynaecology, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Kar Loen CHAN, MBBChir (Cantab); MD (HK)

CONTACT

852-2255 4265; kklchan@hku.hk

Tina Na WEI, PhD

CONTACT

852-22554265; tinawei@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomised into three groups. 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. There is no blinding for waiting-list control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Chairperson and Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 10, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)