RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group • ClinicalTrials.gov ID: NCT05850130

Registry updated: 2026-09-11

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Description

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.

Interventions

Acupuncture intervention (Other)
6 weeks of acupuncture once a week. The acupuncture intervention will consist of weekly session administered over a period of 6 weeks (± 4 days). A two-way verum acupuncture treatment protocol will employ 8 selected acupoints. After week 7, patients included in Arm A may receive an optional 6 weeks of acupuncture. This option of acupuncture continuation will be left to the patient choice in agreement with a physician acupuncturist.
No acupuncture (Other)
The patient in the Arm B will not receive acupuncture treatment for a period of 6 weeks after randomization (weeks 1-6) and during the following weeks 8-13 (acupuncture intervention) if its NRS score is \<4/10 at week 7. If the patient' NRS score is ≥ 4/10 at week 7, the patient in control Arm B will receive the same acupuncture intervention that the patient in the Arm A (6 weeks).

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. 10. Had photobiomodulation therapy sessions in the last month prior to inclusion (this therapy is not permitted during the study)

Conditions

Colorectal Cancer Liver Cancer Gastric Cancer Pancreas Cancer Esophagus Cancer

Locations

CH Amiens-Picardie — Amiens, France
CHU de Caen — Caen, France
Centre intercommunal de Créteil — Créteil, France
Hôpital Henri Mondor — Créteil, France
Ghm - Institut Daniel Hollard — Grenoble, France
CH Lille — Lille, France
Centre Hospitalier Universitaire de Nimes - Site de Caremeau — Nîmes, France
Hôpital Bichat — Paris, France
Hôpital Pitié Salpêtrière — Paris, France
Hôpital Saint Antoine — Paris, France
Institut Curie-Paris — Paris, France
Saint-Louis Hospital — Paris, France
Curie Saint-Cloud — Saint-Cloud, France
Bégin Military Teaching Hospital — Saint-Mandé, France
Paul Brousse Hospital — Villejuif, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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