Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQinghai Red Cross Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Mecobalamin
DrugOral 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.
Treatment groups
326 Participants
are divided into 2 treatment groupsGroup A: Mecobalamin ProphylaxisExperimental treatment 1 intervention
Group B: No Routine Mecobalamin ProphylaxisNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From randomization up to 24 weeks (maximum planned chemotherapy duration).Secondary outcomes
1
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).
Time frame
From randomization up to 24 weeks (maximum planned chemotherapy duration).2
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).
Time frame
From randomization up to 24 weeks (maximum planned chemotherapy duration).3
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).
Time frame
From randomization up to 24 weeks (maximum planned chemotherapy duration).4
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).
Time frame
From randomization up to 24 weeks (maximum planned chemotherapy duration).Other outcomes
1
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.
Time frame
Baseline and end of chemotherapy (up to 24 weeks).Sponsors and contacts
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Source ClinicalTrials.gov