Acupuncture for treating nerve pain caused by chemotherapy in cancer patients
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 (ACUPOX)
This study is testing if acupuncture can help cancer patients with nerve pain caused by chemotherapy feel better after stopping their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 5 sites (Créteil and 4 other locations) |
| Trial ID | NCT05850130 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of acupuncture in alleviating oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who have stopped oxaliplatin-based chemotherapy. It is a multicenter, open-label study with two cohorts: one comparing acupuncture to a control group and another involving a single-arm design. The acupuncture treatments will be administered by trained physician acupuncturists, and patients may continue receiving other chemotherapy treatments during the study. The study adheres to strict guidelines for reporting acupuncture interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with gastrointestinal solid tumors who have experienced significant nerve pain after oxaliplatin treatment.
Not a fit: Patients who have not received oxaliplatin-based chemotherapy or those with a performance status above 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological option for managing chemotherapy-induced nerve pain in cancer patients.
How similar studies have performed: Previous studies have shown promising results for acupuncture in managing chemotherapy-induced neuropathy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Patient is included if: 1. Agree to participate in this study, voluntarily signing a written informed consent form, 2. Aged ≥ 18 years, 3. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2, 4. Have histologically or cytologically confirmed gastro-intestinal solid tumors, previously treated with any oxaliplatin-based chemotherapy; a concomitant radio-chemotherapy course is allowed, 5. Had the last oxaliplatin infusion \> 2 weeks before inclusion, 6. Present OIPN with a numerical rating score (NRS) ≥ 4/10 at inclusion, 7. Currently receiving or recently completed chemotherapy (adjuvant, neoadjuvant, or advanced stage). Patients may receive current chemotherapy treatment (e.g., with FOLFIRI, 5-fluorouracil, bevacizumab regimens), excluding platinum salts and taxane-based regimens during the study, 8. Are able to understand/read French, 9. Are registered in a national health care system (PUMa - Protection Universelle Maladie included), Exclusion Criteria Patients is excluded if: 1. Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion, 2. Had previous and/or current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen \[docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil\]), 3. Have a history of preexisting clinically-significant peripheral neuropathy due to any cause other than chemotherapy (borrelia infection, human immunodeficiency virus infection, hereditary factors, tumor compression, nutritional deprivation, alcohol, diabetes, etc.), 4. Have a recent history (within 4 weeks prior to start of acupuncture) of abusing alcohol, prescription, or illicit drugs (including cannabinoid), or medical, psychological, or social conditions that may interfere with the patient's compliance with the study intervention, NB: The patient should be informed that drinking alcohol should be avoided while on study. 5. Have any other condition that, in the opinion of the investigator, is unstable or could jeopardize the safety of the patient and her/his compliance during the study, 6. Have limb edema of grade 3 (CTCAE v5), 7. Had phytotherapy within 2 weeks before a week 1-14 intervention, 8. Are pregnant or breastfeeding, 9. Are under the tutorship or guardianship of the state or in custody of the justice system.
Where this trial is running
Créteil and 4 other locations
- Centre intercommunal de Créteil — Créteil, France (Not_yet_recruiting)
- Hôpital Henri Mondor — Créteil, France (Recruiting)
- Institu Daniel Hollard — Grenoble, France (Not_yet_recruiting)
- Hôpital Pitié Salpêtrière — Paris, France (Not_yet_recruiting)
- Hôpital Saint Antoine — Paris, France (Recruiting)
Study contacts
- Principal investigator: Emmanuelle Kempf, MD — Henri Mondor University Hospital
- Study coordinator: Marie Line GARCIA LARNICOL
- Email: regulatory.affairs@gecor.com.fr
- Phone: 0140298500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.