Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05850130

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

Led by GERCOR - Multidisciplinary Oncology Cooperative Group · Updated on 2025-07-23

182

Participants Needed

5

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Written informed consent given voluntarily
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Histologically or cytologically confirmed gastro-intestinal solid tumors
  • Previously treated with oxaliplatin-based chemotherapy
  • Last oxaliplatin infusion more than 2 weeks before inclusion
  • Peripheral neuropathy with a numerical rating score of 4 or higher at inclusion
  • Currently receiving or recently completed chemotherapy excluding platinum salts and taxane-based regimens
  • Able to understand and read French
  • Registered in a national health care system (PUMa included)
Not Eligible

You will not qualify if you...

  • Received acupuncture for chemotherapy side effects within 3 months prior to inclusion
  • Previous or current chemotherapy with taxane-based regimens
  • Preexisting clinically significant peripheral neuropathy from causes other than chemotherapy
  • History of recent (within 4 weeks) abuse of alcohol, prescription, or illicit drugs or other conditions affecting study compliance
  • Any unstable condition that could affect safety or compliance during the study
  • Limb edema grade 3 (CTCAE v5)
  • Phytotherapy within 2 weeks before intervention
  • Pregnant or breastfeeding
  • Under tutorship, guardianship, or in custody of the justice system

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Centre intercommunal de Créteil

Créteil, France

Not Yet Recruiting

2

Hôpital Henri Mondor

Créteil, France

Actively Recruiting

3

Institu Daniel Hollard

Grenoble, France

Not Yet Recruiting

4

Hôpital Pitié Salpêtrière

Paris, France

Not Yet Recruiting

5

Hôpital Saint Antoine

Paris, France

Actively Recruiting

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Research Team

M

Marie Line GARCIA LARNICOL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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