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

Launched by GERCOR - MULTIDISCIPLINARY ONCOLOGY COOPERATIVE GROUP · Apr 28, 2023

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: Acupuncture for Oxaliplatin-Induced Peripheral Neuropathy**

This clinical trial, known as ACUPOX, is exploring whether acupuncture can help reduce nerve pain caused by a chemotherapy drug called oxaliplatin in patients with certain types of gastrointestinal cancers, such as colorectal, liver, gastric, pancreas, and esophagus cancer. The study is currently recruiting participants aged 18 and older who have experienced significant nerve pain (rated 4 or higher on a scale of 0 to 10) after receiving oxaliplatin treatment. To qualify, patients must have stopped their oxaliplatin chemotherapy for at least two weeks and should be able to understand French.

Participants in this trial can expect to receive acupuncture treatments over a set period. The goal is to see if this therapy can help alleviate their nerve pain and improve their quality of life. It's important to note that individuals with certain conditions or who have recently undergone other specific treatments may not be eligible. If you're interested in participating, it’s a good idea to discuss this trial with your healthcare provider to see if it could be a suitable option for you.

Gender

ALL

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.