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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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).

Первичные конечные точки

• 2-point improvement in the global NRS [Срок оценки: Week 7]

Вторичные конечные точки (4)

• Numerical Rating Scale (NRS) score [Срок оценки: Week 7]
• Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire [Срок оценки: Assess at baseline, at week 7, 14, and at 6 months]
• Brief Pain Inventory (BPI) score [Срок оценки: Assess at baseline, at week 7, 14, and at 6 months]
• Peripheral sensory neuropathy grading scale [Срок оценки: Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months]

Критерии участия

Критерии включения

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,
• Had the last oxaliplatin infusion > 2 weeks before inclusion,
• Present OIPN with a numerical rating score (NRS) ≥ 4/10 at inclusion,
• 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),

Критерии исключения

Patients is excluded if:

• Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion,
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 5 центров

• Centre intercommunal de Créteil — Créteil
• Hôpital Henri Mondor — Créteil
• Institu Daniel Hollard — Grenoble
• Hôpital Pitié Salpêtrière — Paris
• Hôpital Saint Antoine — Paris

Идентификаторы

NCT: NCT05850130 · ACUPOX G-114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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