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

Korábbi kezelés

• Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion,
• Had previous and/or current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen [docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil]),
• 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.
• Had phytotherapy within 2 weeks before a week 1-14 intervention,
• Had photobiomodulation therapy sessions in the last month prior to inclusion (this therapy is not permitted during the study)

Más betegség

• 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.),
• 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,

Egyéb

• Patients is excluded if:
• Have limb edema of grade 3 (CTCAE v5),
• Are pregnant or breastfeeding,
• Are under the tutorship or guardianship of the state or in custody of the justice system.

• Patient is included if:
• Agree to participate in this study, voluntarily signing a written informed consent form,
• Aged ≥ 18 years,
• Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,
• Have histologically or cytologically confirmed gastro-intestinal solid tumors, previously treated with any oxaliplatin-based chemotherapy; a concomitant radio-chemotherapy course is allowed,
• Had the last oxaliplatin infusion > 2 weeks before inclusion,
• Present OIPN with a numerical rating score (NRS) ≥ 4/10 at inclusion,
• 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,
• Are able to understand/read French,
• Are registered in a national health care system (PUMa - Protection Universelle Maladie included),