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โ† Trials
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Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy

RecruitingPhase 3Ages 18 Years - anyAllQinghai Red Cross Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 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; 2. Age โ‰ฅ18 years; 3. 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; 4. Life expectancy โ‰ฅ3 months; 5. ECOG performance status 0-2; 6. Adequate major organ function (cardiac, hepatic, renal, and bone marrow function); 7. Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: 1. Severe impairment of major organ function such that the participant cannot tolerate standard-dose chemotherapy; 2. Pre-existing peripheral neuropathy or a history of peripheral neuropathy; 3. Skin conditions (e.g., severe palmoplantar keratoderma, active skin infection) that may interfere with assessment of CIPN symptoms; 4. Recent use of medications that may alleviate CIPN symptoms; 5. Inability to swallow, intestinal obstruction, or other conditions that may affect drug absorption; 6. Known hypersensitivity or allergy to mecobalamin; 7. Pregnant or breastfeeding women.
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What it tests

  • Mecobalamin
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Where

4 sites
Affiliated Hospital of Qinghai University
Xining, China
Qinghai Red Cross Hospital
Xining, China
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
Jinan, China
Beijing Chaoyang Sanhuan Cancer Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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