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NCT05850130Recruiting

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)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
182 (estimated)
First submitted
28 Apr 2023
Start date
22 Nov 2023
Primary completion date
Oct 2026
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
NCT number
NCT05850130

What you commit to

  • Study type: Interventional
  • Planned participants: 182
  • From 22 Nov 2023 to the primary completion date, Oct 2026
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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,

Other

  • 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.

Who the study is looking for

  • 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),

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH Amiens-Picardie
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
CHU de CAEN
Coordinator of this site? Confirm its status
CaenFranceNot yet recruiting
Hopital Henri Mondor
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
Centre intercommunal de Créteil
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
Ghm - Institut Daniel Hollard
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
CH Lille
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
Centre Hospitalier Universitaire de Nimes - Site de Caremeau
Coordinator of this site? Confirm its status
NîmesFranceRecruiting
Hopital Pitie-Salpetriere
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Institut Curie Paris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Bichat
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ParisFranceNot yet recruiting
Saint Louis Hospital
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ParisFranceNot yet recruiting
Curie Saint-Cloud
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Saint-CloudFranceNot yet recruiting
Bégin Military Teaching Hospital
Coordinator of this site? Confirm its status
Saint-MandéFranceNot yet recruiting
Paul Brousse Hospital
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.