Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Mecobalamin
  Oral mecobalamin tablets, 0.5 mg three times daily (total 1.5 mg/day), starting on Day 1 of taxane-based chemotherapy and continuing until completion of chemotherapy, administered as prophylaxis for chemotherapy-induced peripheral neuropathy. Participants in both groups are not permitted to use any other medications or supplements specifically for the prophylaxis of CIPN during the study period. However, if CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provid

Первичные конечные точки

• Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN) [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]

Вторичные конечные точки (9)

• Cumulative incidence of any grade CIPN [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Median time to first occurrence of grade ≥2 CIPN [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Cumulative incidence of grade 2 CIPN [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Cumulative incidence of grade ≥3 CIPN [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Changes in EORTC QLQ-CIPN20 scores over time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Relative dose intensity (RDI) of taxane chemotherapy [Срок оценки: From randomization up to 24 weeks (maximum planned chemotherapy duration).]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: From randomization through 6 months after chemotherapy completion.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 4 центра

• Affiliated Hospital of Qinghai University — Xining
• Qinghai Red Cross Hospital — Xining
• Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital) — Цзинань
• Beijing Chaoyang Sanhuan Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07423390 · KY-2025-214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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