Actively Recruiting
A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy
Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-07-23
182
Participants Needed
5
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a standardized acupuncture protocol on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal solid tumors who have stopped oxaliplatin-containing chemotherapy. This phase II, multicenter, open-label study includes two cohorts: one randomized into two groups and one single-arm group. The study follows acupuncture treatment guidelines to ensure consistent delivery by trained physician acupuncturists. Participants in the randomized cohort are assigned to either receive weekly acupuncture for six weeks or no acupuncture for six weeks. Those receiving acupuncture get sessions targeting eight specific acupoints each week. At week 7, outcomes are assessed, and patients in the acupuncture group may choose to continue treatment for another six weeks. In the non-acupuncture group, patients with higher symptom scores at week 7 receive acupuncture for six weeks, while others do not. Throughout the study, participants undergo evaluations including symptom rating scales, quality of life questionnaires related to chemotherapy-induced neuropathy, pain inventories, and neuropathy grading at several points up to six months. Researchers monitor symptoms to measure improvement and track safety. The total involvement includes regular acupuncture sessions, assessments at baseline, weeks 7, 14, and follow-up at six months to observe lasting effects.
CONDITIONS
Brief Title
Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate in this study by signing a written informed consent form
- Aged 18 years or older
- Have an Eastern Cooperative Oncology Group performance status of 0 to 2
- Have histologically or cytologically confirmed gastro-intestinal solid tumors previously treated with oxaliplatin-based chemotherapy
- Last oxaliplatin infusion was more than 2 weeks before inclusion
- Present oxaliplatin-induced peripheral neuropathy with a numerical rating score of 4 or higher at inclusion
- Currently receiving or recently completed chemotherapy excluding platinum salts and taxane-based regimens
- Able to understand and read French
- Registered in a national health care system (Protection Universelle Maladie included)
You will not qualify if you...
- Had acupuncture sessions for chemotherapy side effect prevention in the last 3 months before inclusion
- Previous or current chemotherapy treatments with taxane-based regimens
- History of clinically significant peripheral neuropathy from causes other than chemotherapy
- Recent history of alcohol, drug abuse, or medical, psychological, or social conditions interfering with study compliance
- Any unstable condition that could jeopardize safety or compliance during the study
- Limb edema of grade 3 (CTCAE v5)
- Had phytotherapy within 2 weeks before week 1 to 14 intervention
- Pregnant or breastfeeding
- Under tutorship, guardianship, or custody of the justice system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks, with an optional additional 6 weeks
Participants receive acupuncture once a week for 6 weeks. At week 7, participants are assessed for their symptom improvement. Depending on their score and agreement with the physician acupuncturist, they may choose to continue acupuncture for an additional 6 weeks.
Weekly visits for up to 6 weeks, with optional weekly visits for an additional 6 weeks
Duration - 6 months
Participants are assessed for symptom and quality of life changes at weeks 7, 14, and 6 months after starting treatment.
3 visits (weeks 7, 14, and 6 months)
Trial Site Locations
Total: 5 locations
1
Centre intercommunal de Créteil
Créteil, France
Not Yet Recruiting
2
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
3
Institu Daniel Hollard
Grenoble, France
Not Yet Recruiting
4
Hôpital Pitié Salpêtrière
Paris, France
Not Yet Recruiting
5
Hôpital Saint Antoine
Paris, France
Actively Recruiting
Research Team
M
Marie Line GARCIA LARNICOL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here