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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status: Enrolling

Conditions: Esophagus Cancer; Gastric Cancer; Pancreas Cancer; Liver Cancer; Colorectal Cancer

Treatments: Other: No acupuncture; Other: Acupuncture intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05850130

ACUPOX G-114

Details and patient eligibility

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.

Full 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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Other: Acupuncture intervention

Arm B

Active Comparator group

Description:

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,

Treatment:

Other: No acupuncture