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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 18
- 主要终点
- 2-point improvement in the global NRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
排除标准
- •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.
- •Had photobiomodulation therapy sessions in the last month prior to inclusion (this therapy is not permitted during the study)
研究组 & 干预措施
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.
干预措施: Acupuncture intervention (Other)
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,
干预措施: No acupuncture (Other)
结局指标
主要结局
2-point improvement in the global NRS
时间窗: Week 7
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).
次要结局
- Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy twenty-item scale (QLQ-CIPN20) questionnaire(Assess at baseline, at week 7, 14, and at 6 months)
- Peripheral sensory neuropathy grading scale(Assess at baseline, at each intervention visit, at week 7, 14, and at 6 months)
- Brief Pain Inventory (BPI) score(Assess at baseline, at week 7, 14, and at 6 months)
- Numerical Rating Scale (NRS) score(Week 7)