RecruitingNot ApplicableNCT05850130

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

A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy (ACUPOX)


Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Enrollment

182 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether acupuncture can reduce nerve pain and tingling in the hands and feet (called peripheral neuropathy) caused by oxaliplatin — a chemotherapy drug commonly used to treat bowel and other gastrointestinal cancers. Nerve damage from oxaliplatin can be lasting and significantly affect quality of life. **You may be eligible if...** - You are 18 or older - You have a confirmed gastrointestinal cancer and have previously received oxaliplatin-based chemotherapy - You are experiencing persistent nerve symptoms (pain, numbness, or tingling) in your hands or feet - You are in reasonably good health and able to participate **You may NOT be eligible if...** - You have a pre-existing nerve condition unrelated to chemotherapy - You are currently receiving oxaliplatin chemotherapy (you must have completed it) - You have a bleeding disorder or are on blood thinners that would make acupuncture unsafe - You are pregnant - You have had prior acupuncture treatment for this specific problem during the same period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAcupuncture intervention

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.

OTHERNo acupuncture

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).


Locations(5)

Centre intercommunal de Créteil

Créteil, France

Hôpital Henri Mondor

Créteil, France

Institu Daniel Hollard

Grenoble, France

Hôpital Pitié Salpêtrière

Paris, France

Hôpital Saint Antoine

Paris, France

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NCT05850130