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

RecruitingNAAges 18 Years - anyAllGERCOR - Multidisciplinary Oncology Cooperative G…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Acupuncture intervention
  • No acupuncture
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Where

15 sites
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

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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