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Tests treatment safety and results for Peripheral Neuropathy Due to Chemotherapy
Official title Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07423390
What this study is testing
What is Mecobalamin?
Mecobalamin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral neuropathy due to chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed solid tumors, including but not limited to breast cancer, lung cancer, gastric cancer, cervical cancer...
- Age ≥18 years;
- Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (including paclitaxel, nab-paclitaxel, or docetaxel; as monotherapy or in...
- Life expectancy ≥3 months;
- ECOG performance status 0-2;
You likely can't join 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;
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xining, Qinghai, China
- Jinan, Shandong, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xining, Qinghai, China; Jinan, Shandong, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.