NCT05850130 Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
| NCT ID | NCT05850130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2023-11-22 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ACUPOX is a multicenter, open label, 2-cohort based phase II clinical study evaluating the interest of a standardized protocol of verum acupuncture in treatment of Oxaliplatin-induced peripheral neuropathy in patients with gastro-intestinal solid tumors who discontinued oxaliplatin-containing chemotherapy.
Eligibility 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.
Contact & Investigator
Emmanuelle Kempf, MD
PRINCIPAL INVESTIGATOR
Henri Mondor University Hospital
Frequently Asked Questions
Who can join the NCT05850130 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05850130 currently recruiting?
Yes, NCT05850130 is actively recruiting participants. Contact the research team at regulatory.affairs@gecor.com.fr for enrollment information.
Where is the NCT05850130 trial being conducted?
This trial is being conducted at Créteil, France, Créteil, France, Grenoble, France, Paris, France and 1 additional location.
Who is sponsoring the NCT05850130 clinical trial?
NCT05850130 is sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. The principal investigator is Emmanuelle Kempf, MD at Henri Mondor University Hospital. The trial plans to enroll 182 participants.
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