Acupuncture for treating nerve pain caused by chemotherapy in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of acupuncture in alleviating oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who have stopped oxaliplatin-based chemotherapy. It is a multicenter, open-label study with two cohorts: one comparing acupuncture to a control group and another involving a single-arm design. The acupuncture treatments will be administered by trained physician acupuncturists, and patients may continue receiving other chemotherapy treatments during the study. The study adheres to strict guidelines for reporting acupuncture interventions.

Why it matters

Who can join: the full rules

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)

Where it's running

• CH Amiens-Picardie
  Amiens, France Recruiting
• Centre intercommunal de Créteil
  Créteil, France Recruiting
• Hôpital Henri Mondor
  Créteil, France Recruiting
• Ghm - Institut Daniel Hollard
  Grenoble, France Recruiting
• Centre Hospitalier Universitaire de Nimes - Site de Caremeau
  Nîmes, France Recruiting
• Hôpital Pitié Salpêtrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Emmanuelle Kempf, MD — Henri Mondor University Hospital
• Study coordinator: Marie Line GARCIA LARNICOL
• Email: regulatory.affairs@gecor.com.fr
• Phone: 0140298500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.