Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 4
- 主要终点
- Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN)
研究概览
简要总结
Some patients receiving taxane-based chemotherapy experience numbness, tingling, or pain in their hands and feet, known as chemotherapy-induced peripheral neuropathy (CIPN). This study aims to find out whether oral mecobalamin can prevent or reduce CIPN. Participants will be assigned to take mecobalamin or to receive no routine mecobalamin prevention during chemotherapy, and outcomes will be compared between groups.
详细描述
This is a prospective, multicenter, open-label randomized controlled trial to evaluate oral mecobalamin for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with solid tumors receiving taxane-based chemotherapy. Participants are assigned to receive prophylactic mecobalamin (0.5 mg orally three times daily, starting on the first day of taxane-based chemotherapy and continuing until chemotherapy completion) or no routine mecobalamin prophylaxis. The primary endpoint is the cumulative incidence of grade ≥2 CIPN (CTCAE v6.0) from randomization to the end of chemotherapy.
Secondary endpoints include measures of CIPN onset and severity, patient-reported outcomes (PROs), chemotherapy delivery, and safety. Study assessments are conducted at baseline and during each chemotherapy cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed solid tumors, including but not limited to breast cancer, lung cancer, gastric cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and melanoma;
- •Age ≥18 years;
- •Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (including paclitaxel, nab-paclitaxel, or docetaxel; as monotherapy or in combination) for early-stage disease, or has advanced disease with no prior chemotherapy;
- •Life expectancy ≥3 months;
- •ECOG performance status 0-2;
- •Adequate major organ function (cardiac, hepatic, renal, and bone marrow function);
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Severe impairment of major organ function such that the participant cannot tolerate standard-dose chemotherapy;
- •Pre-existing peripheral neuropathy or a history of peripheral neuropathy;
- •Skin conditions (e.g., severe palmoplantar keratoderma, active skin infection) that may interfere with assessment of CIPN symptoms;
- •Recent use of medications that may alleviate CIPN symptoms;
- •Inability to swallow, intestinal obstruction, or other conditions that may affect drug absorption;
- •Known hypersensitivity or allergy to mecobalamin;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
No Routine Mecobalamin Prophylaxis
Participants do not receive routine mecobalamin prophylaxis. Follow-up schedule, education, and outcome assessments are the same as in the mecobalamin group. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.
Mecobalamin Prophylaxis
Participants receive oral mecobalamin 0.5 mg three times daily (total 1.5 mg/day), starting on the first day of taxane chemotherapy and continuing until completion of chemotherapy. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.
干预措施: Mecobalamin (Drug)
结局指标
主要结局
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN)
时间窗: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Defined as the proportion of participants who experience grade ≥2 CIPN (assessed by CTCAE v6.0) at any time from randomization to the end of chemotherapy (or earlier discontinuation).
次要结局
- Cumulative incidence of any grade CIPN(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Median time to first occurrence of grade ≥2 CIPN(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Cumulative incidence of grade 2 CIPN(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Cumulative incidence of grade ≥3 CIPN(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Changes in EORTC QLQ-CIPN20 scores over time(Baseline; during each chemotherapy cycle; end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.)
- Changes in EQ-5D-5L scores over time(Baseline; mid-treatment (at the midpoint of planned chemotherapy cycles, up to 12 weeks), end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.)
- Proportion of participants with taxane chemotherapy dose modification due to CIPN(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Relative dose intensity (RDI) of taxane chemotherapy(From randomization up to 24 weeks (maximum planned chemotherapy duration).)
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(From randomization through 6 months after chemotherapy completion.)
研究者
Dongqiuxia
Clinical Professor
Qinghai Red Cross Hospital