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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy Due to Chemotherapy; Peripheral Neuropathy, Chemotherapy-induced
• Intervention / Treatment: Drug: Mecobalamin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 326
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jiuda Zhao, Dr; Phone Number: 869716230893; Email: jiudazhao@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Chaoyang Sanhuan Cancer Hospital
    • Contact: Huachao Feng; Phone Number: (010)67475557-890; Email: sytfhc870116@126.com
  • Qinghai
    • Xining, Qinghai, China
      • Recruiting
      • Qinghai Red Cross Hospital
      • Contact: Qiuxia Dong; Phone Number: 0971-8212924; Email: 2816278916@qq.com
    • Xining, Qinghai, China
      • Not yet recruiting
      • Affiliated Hospital of Qinghai University
      • Contact: Jiuda Zhao; Phone Number: 0971-6162000; Email: jiudazhao@126.com
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
      • Contact: Huihui Li; Phone Number: 0531-67626929; Email: huihuili82@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ≥18 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 ≥3 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 provide standard symptomatic treatment in accordance with current clinical guidelines.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN)	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).	From randomization up to 24 weeks (maximum planned chemotherapy duration).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of any grade CIPN	Defined as the proportion of participants who experience CIPN of any grade (assessed by CTCAE v6.0) at any time from randomization to the end of chemotherapy (or earlier discontinuation).	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Median time to first occurrence of grade ≥2 CIPN	Defined as the median time from randomization to the first occurrence of grade ≥2 CIPN (assessed by CTCAE v6.0). Participants without grade ≥2 CIPN will be censored at the end of chemotherapy (or earlier discontinuation).	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Cumulative incidence of grade 2 CIPN	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).	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Cumulative incidence of grade ≥3 CIPN	Defined as the proportion of participants who experience grade ≥3 CIPN (assessed by CTCAE v6.0) at any time from randomization to the end of chemotherapy (or earlier discontinuation).	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Changes in EORTC QLQ-CIPN20 scores over time	The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20-item questionnaire (EORTC QLQ-CIPN20) is a validated patient-reported outcome instrument assessing CIPN-related symptoms and functional impairment. It includes 20 items covering sensory, motor, and autonomic symptoms, each rated on a 4-point Likert scale. Raw scores are linearly transformed to 0 to 100 points according to the EORTC scoring manual; higher scores indicate worse symptom burden and functional limitations. The questionnaire will be administered at multiple time points to characterize the trajectory of CIPN during and after chemotherapy.	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	The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized instrument for measuring health-related quality of life. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five levels. EQ-5D-5L responses will be converted to a single utility index score using the China EQ-5D-5L value set (1 = full health; 0 = dead; values may be < 0); higher index scores indicate better health. The EQ-5D-5L also includes a vertical visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health); higher VAS scores indicate better self-rated health. Both the index score and VAS score will be assessed at multiple time points to evaluate changes in health-related quality of life during and after chemotherapy.	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	Defined as the proportion of participants who have taxane dose reduction, dose delay, or treatment discontinuation attributable to CIPN during the taxane chemotherapy period.	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Relative dose intensity (RDI) of taxane chemotherapy	Defined as the relative dose intensity of taxane chemotherapy over the planned treatment period (actual dose intensity relative to the protocol/planned dose intensity), summarized for each participant.	From randomization up to 24 weeks (maximum planned chemotherapy duration).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Incidence and severity of AEs and SAEs occurring during the study.	From randomization through 6 months after chemotherapy completion.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower-limb sensory nerve conduction velocity (SNCV) assessed by nerve conduction studies (NCS)	Change in lower-limb SNCV (m/s) assessed by NCS. NCS will be performed on the sural sensory nerve using standard surface stimulation and recording electrodes, following harmonized procedures across sites where NCS is performed. SNCV will be calculated from sensory nerve latency (ms) and the stimulation-to-recording distance; sensory nerve action potential (SNAP) amplitude (μV) and latency (ms) will also be recorded. Testing is optional and will be performed in a subset of participants at selected sites where NCS equipment and trained personnel are available.	Baseline and end of chemotherapy (up to 24 weeks).

Collaborators and Investigators

• Sponsor: Qinghai Red Cross Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; Taxane; Mecobalamin; Chemotherapy induced peripheral neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; mecobalamin
• Other Study ID Numbers: KY-2025-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie the results reported in publications will be shared with qualified researchers upon reasonable request. Shared IPD will include participant-level data on baseline characteristics, treatment exposure, primary and secondary outcome measures, and safety outcomes. Requests must include a scientifically sound research proposal and analysis plan. Access will be granted after approval by the study steering committee and completion of a data use agreement.
• IPD Sharing Time Frame: Beginning after publication of the primary results and available for 3 years.
• IPD Sharing Access Criteria: De-identified IPD and supporting documents will be made available to qualified researchers upon submission of a scientifically valid research proposal to the corresponding author. Access requires approval by the study steering committee and the completion of a data use agreement to ensure appropriate data use and participant confidentiality.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No