Clinical trial NCT05850130: Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Liver Cancer
Gastric Cancer
Pancreas Cancer
Esophagus Cancer
Keywords: acupuncture
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, 2-cohort phase II study:

Cohort 1: randomization into Arm A = Experimental or Arm B = Control

Cohort 2: a single arm.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 2-point improvement in the global NRS
timeFrame: Week 7
Secondary outcomes:
measure: Numerical Rating Scale (NRS) score
timeFrame: Week 7
measure: Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire
timeFrame: Assess at baseline, at week 7, 14, and at 6 months
measure: Brief Pain Inventory (BPI) score
timeFrame: Assess at baseline, at week 7, 14, and at 6 months
measure: Peripheral sensory neuropathy grading scale
timeFrame: Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre intercommunal de Créteil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: Institu Daniel Hollard
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint Antoine
Study officials:
affiliation: Henri Mondor University Hospital
name: Emmanuelle Kempf, MD
role: PRINCIPAL_INVESTIGATOR
References: