Health TrialsbyHealthPanel

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

ConditionsGynaecological, Urological or Rectal CancerChemotherapy-Induced Peripheral NeuropathyAcupuncture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKaren Kar Loen CHAN

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or above

Diagnosis of uterine (endometrial) cancer, ovarian cancer and cervical cancer

ECOG=0-2

Life expectancy of > 6 months

Disqualifiers

Bleeding tendency

Abnormal clotting profile

Platelet lower than 50

Received acupuncture in the past

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Procedure/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 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: AcupunctureExperimental treatment 1 intervention
Group B: Sham acupunctureSham comparator 1 intervention
Group C: Waiting-list (usual care) controlNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

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
2

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

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
3

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.

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
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karen Kar Loen CHAN

Lead sponsor

The University of Hong Kong

Sponsor institution

Source ClinicalTrials.gov
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