Vitamin B12 trial aims to stop Chemo's painful side effect
NCT ID NCT07423390
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking mecobalamin (a form of vitamin B12) can prevent or reduce nerve damage caused by taxane chemotherapy. About 326 adults with various solid tumors will take mecobalamin tablets or receive no preventive treatment during their chemo. The goal is to see if fewer people develop numbness, tingling, or pain in their hands and feet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mecobalamin (a form of vitamin B12)
- What this could lead to
- If it works, this could provide a simple, low-cost way to prevent painful nerve damage during chemotherapy.
- What could go wrong
- This is a single-center trial, and the benefit may be modest or not confirmed. Mecobalamin is generally safe but may not prevent all nerve symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 326 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
NOT_YET_RECRUITINGJinan, Shandong, China
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Affiliated Hospital of Qinghai University
NOT_YET_RECRUITINGXining, Qinghai, China
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Beijing Chaoyang Sanhuan Cancer Hospital
RECRUITINGBeijing, China
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Qinghai Red Cross Hospital
RECRUITINGXining, Qinghai, China
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