NCT07423390

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
34mo left

Started Feb 2026

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026May 2029

First Submitted

Initial submission to the registry

February 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 24, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

April 30, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

February 12, 2026

Last Update Submit

April 25, 2026

Conditions

Peripheral Neuropathy Due to ChemotherapyPeripheral Neuropathy, Chemotherapy-induced

Keywords

Chemotherapy induced peripheral neuropathyMecobalaminTaxanePrevention

Outcome Measures

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).

    From randomization up to 24 weeks (maximum planned chemotherapy duration).

Secondary Outcomes (9)

  • 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.

  • +4 more secondary outcomes

Other Outcomes (1)

  • Change in lower-limb sensory nerve conduction velocity (SNCV) assessed by nerve conduction studies (NCS)

    Baseline and end of chemotherapy (up to 24 weeks).

Study Arms (2)

Mecobalamin Prophylaxis

EXPERIMENTAL

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

No Routine Mecobalamin Prophylaxis

NO INTERVENTION

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.

Interventions

MecobalaminDRUG

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.

Mecobalamin Prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

NOT YET RECRUITING

Qinghai Red Cross Hospital

Xining, Qinghai, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)

Jinan, Shandong, China

NOT YET RECRUITING

Beijing Chaoyang Sanhuan Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Central Study Contacts

Jiuda Zhao, Dr

CONTACT

869716230893jiudazhao@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 20, 2026

Study Start

February 24, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

April 30, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning after publication of the primary results and available for 3 years.
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.

Locations

CN(4)