The Use of Acupuncture to Reduce Chemotherapy Induced Peripheral Neuropathy in Gynaecological Cancer Patients
NCT ID: NCT06769061
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-01-31
2027-12-31
Brief Summary
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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. 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. 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.
Main outcomes:
Acupuncture effects will be assessed at baseline and 3, 6,12 weeks post intervention by:
1. 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
2. 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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Acupuncture
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.
Acupuncture
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 acupuncture
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.
sham acupuncture
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.
Waiting-list (usual care) control
Patients randomised to the waiting-list control group will receive standard of care managementf for CIPN.
No interventions assigned to this group
Interventions
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Acupuncture
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 acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Karen Kar Loen CHAN
OTHER
Responsible Party
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Karen Kar Loen CHAN
Department Chairperson and Clinical Professor
Principal Investigators
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Karen Kar Loen Prof CHAN, MBBChir (Cantab); MD (HK)
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynaecology, the University of Hong Kong
Locations
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Department of Obstetrics and Gynaecology
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Karen Kar Loen CHAN, MBBChir (Cantab); MD (HK)
Role: backup
Other Identifiers
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AcuCIN
Identifier Type: -
Identifier Source: org_study_id
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