Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07423390

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

Led by Qinghai Red Cross Hospital · Updated on 2026-04-30

326

Participants Needed

4

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed solid tumors, including breast, lung, gastric, cervical, endometrial, ovarian, pancreatic cancers, or melanoma
  • Age 18 years or older
  • Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (paclitaxel, nab-paclitaxel, or docetaxel) for early disease, or advanced disease with no prior chemotherapy
  • Life expectancy of at least 3 months
  • ECOG performance status of 0 to 2
  • Adequate function of major organs including heart, liver, kidneys, and bone marrow
  • Willing and able to provide written informed consent and follow study procedures
Not Eligible

You will not qualify if you...

  • Severe major organ dysfunction preventing standard-dose chemotherapy
  • Existing peripheral neuropathy or history of peripheral neuropathy
  • Skin conditions that could interfere with CIPN symptom assessment, such as severe palmoplantar keratoderma or active skin infection
  • Recent use of medications that relieve CIPN symptoms
  • Difficulty swallowing, intestinal blockage, or conditions affecting drug absorption
  • Known allergy or hypersensitivity to mecobalamin
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Not Yet Recruiting

2

Qinghai Red Cross Hospital

Xining, Qinghai, China

Actively Recruiting

3

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

Jinan, Shandong, China

Not Yet Recruiting

4

Beijing Chaoyang Sanhuan Cancer Hospital

Beijing, China

Actively Recruiting

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Research Team

J

Jiuda Zhao, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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