Acupuncture For Oxaliplatin-induced Peripheral Neuropathy In Gastro-intestinal Cancer Patients

Study Overview

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

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.

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.

Colorectal Cancer
Liver Cancer
Gastric Cancer
Pancreas Cancer
Esophagus Cancer

OTHER: Acupuncture intervention
OTHER: No acupuncture

ACUPOX G-114

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-04-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-22
First Submitted that Met QC Criteria 2023-04-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-23
First Posted (ACTUAL) 2023-05-09	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 wit	OTHER: 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 incl
ACTIVE_COMPARATOR: 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 . *	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 ≥

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 wit

OTHER: 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 incl

ACTIVE_COMPARATOR: 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 . *

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 ≥

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Numerical Rating Scale (NRS) score	A success of acupuncture for the patient is defined by a 2-point improvement on the overall NRS between baseline and week 7 after the randomization of Cohort 1 and inclusion of Cohort 2.	Week 7
Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire	The EORTC QLQ-CIPN20 questionnaire consists of 20 items that are divided into 3 subscales: the items in CIPN20 have been divided into three subscales. The sensory subscale consists of items 1, 2, 3, 4, 5, 6, 9, 10, and 18; motor: items 7, 8, 11, 12, 13, 14, 15, and 19; and autonomic nerve-related: items 16, 17, and 20. Each subscale is summed and linearly transformed to a score that can range from 0 to 100, where higher scores represent greater CIPN symptom severity. Patients will rate their experience for each symptom during the previous week using scores from 1 (not at all) to 4 (very much).	Assess at baseline, at week 7, 14, and at 6 months
Brief Pain Inventory (BPI) score	This 9-item BPI self-reported questionnaire provides information on the intensity of pain and the degree to which pain interferes with function. Pain is rated over the prior week and the degree to which the pain interferes with activities using a 0 to 10-point scale.	Assess at baseline, at week 7, 14, and at 6 months
Peripheral sensory neuropathy grading scale	Severity of the peripheral sensory neuropathies will be classified using a 4-point scale ranging from grade 1 to grade 4 per criteria established in NCI CTCAE v. 5.0.	Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marie Line GARCIA LARNICOL

Phone Number: 0140298500

Email: regulatory.affairs@gecor.com.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Emmanuelle Kempf, MD, Henri Mondor University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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