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Recruiting NCT05850130

Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients

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Trial Parameters

Condition Colorectal Cancer
Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Study Type INTERVENTIONAL
Phase N/A
Enrollment 182
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-22
Completion 2026-10
Interventions
Acupuncture interventionNo acupuncture

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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), Exclus

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