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

NCT ID: NCT05850130

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2027-12-31

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.

Detailed Description

In this design, patients will be randomized into two-arm (2:1 allocation) Cohort 1: a comparative randomized design (Arm A = Experimental vs Arm B = Control) or included into Cohort 2: a single arm design.

The study follows the Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guideline.

All acupuncture interventions will be conducted by a physician acupuncturist. If the patient will be getting chemotherapy (that is optional treatment) during the study duration, acupuncture will be given at the same time.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A

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.

Group Type: EXPERIMENTAL

Acupuncture intervention

Intervention Type: 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 B

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,

Group Type: ACTIVE_COMPARATOR

No acupuncture

Intervention Type: 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).

Interventions

Acupuncture 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.

Intervention Type: OTHER

No 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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle Kempf, MD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

Centre intercommunal de Créteil

Créteil, , France

Site Status: NOT_YET_RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status: RECRUITING

Institu Daniel Hollard

Grenoble, , France

Site Status: NOT_YET_RECRUITING

Hôpital Pitié Salpêtrière

Paris, , France

Site Status: NOT_YET_RECRUITING

Hôpital Saint Antoine

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie Line GARCIA LARNICOL

Role: CONTACT

regulatory.affairs@gecor.com.fr

0140298500

Facility Contacts

Isabelle COJEAN ZELEK, MD

Role: primary

emmanuelle KEMPF, MD

Role: primary

Camille HERVE, MD

Role: primary

Jean Baptiste BACHET, MD

Role: primary

Hélène BOUSSION, MD

Role: primary

Other Identifiers

ACUPOX G-114

Identifier Type: -

Identifier Source: org_study_id