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

NCT05850130 | Recruiting

• 1 other identifier: ACUPOX G-114
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Colorectal Cancer; Liver Cancer; Gastric Cancer; Pancreas Cancer; Esophagus Cancer

Keywords

acupuncture

Outcome Measures

Primary Outcomes (1)

• 2-point improvement in the global NRS

  The primary endpoint is a 2-point improvement in the global numeric rating scale (NRS) score from randomization/inclusion defined by the patient at week 7. The 11-point NRS range from 0 to 10 (0 = no symptom, 1-3 = mild, 4-6 = moderate, 7-10 = severe).

  Week 7

Secondary Outcomes (4)

• Numerical Rating Scale (NRS) score

  Week 7

• Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire

  Assess at baseline, at week 7, 14, and at 6 months

• Brief Pain Inventory (BPI) score

  Assess at baseline, at week 7, 14, and at 6 months

• Peripheral sensory neuropathy grading scale

  Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months

Study Arms (2)

Arm A

EXPERIMENTAL

6 weeks of acupuncture once a week. At week 7, patients will be assessed for the primary endpoint Then ,the patient 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.

Other: Acupuncture intervention

Arm B

ACTIVE COMPARATOR

6 weeks without acupuncture. At week 7, patients will be assessed for the primary endpoint. Then, the patient will receive or not acupuncture intervention: * A mandatory acupuncture once a week if the patient' NRS global score at week 7 is ≥ 4 . * No acupuncture if the patient' NRS global score at week 7 is \<4,

Other: No acupuncture

Interventions

Acupuncture intervention OTHER

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.

Arm A

No acupuncture OTHER

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).

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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),

You may not qualify if:

• Patients is excluded if:
• Had previous and/or current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen \[docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil\]),
• 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 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.
• 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,
• Have limb edema of grade 3 (CTCAE v5),
• Had phytotherapy within 2 weeks before a week 1-14 intervention,
• Are pregnant or breastfeeding,
• Are under the tutorship or guardianship of the state or in custody of the justice system.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (5)

Centre intercommunal de Créteil

Créteil, France

NOT YET RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Institu Daniel Hollard

Grenoble, France

NOT YET RECRUITING

Hôpital Pitié Salpêtrière

Paris, France

NOT YET RECRUITING

Hôpital Saint Antoine

Paris, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Emmanuelle Kempf, MD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Line GARCIA LARNICOL

CONTACT

0140298500; regulatory.affairs@gecor.com.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, 2-cohort phase II study: Cohort 1: randomization into Arm A = Experimental or Arm B = Control Cohort 2: a single arm.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

FR (5)