Peripheral Neuropathy Due to ChemotherapyPhase 3NCT07423390
Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
A Phase 3 study testing Mecobalamin in people with Peripheral Neuropathy Due to Chemotherapy and Peripheral Neuropathy, Chemotherapy-induced, run by Qinghai Red Cross Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Chemotherapy-induced
- What is being tested?
- Mecobalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 4 sitesChina
- Study dates
- 24 Feb 2026to 31 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Chaoyang Sanhuan Cancer Hospital
Beijing
Huachao Feng, (010)67475557-890, sytfhc870116@126.com
- Not yet recruiting
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
Jinan, Shandong
Huihui Li, 0531-67626929, huihuili82@163.com
- Not yet recruiting
Affiliated Hospital of Qinghai University
Xining, Qinghai
Jiuda Zhao, 0971-6162000, jiudazhao@126.com
- Recruiting
Qinghai Red Cross Hospital
Xining, Qinghai
Qiuxia Dong, 0971-8212924, 2816278916@qq.com
About this study
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.
Read the detailed description
This is a prospective, multicenter, open-label randomized controlled trial to evaluate oral mecobalamin for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with solid tumors receiving taxane-based chemotherapy. Participants are assigned to receive prophylactic mecobalamin (0.5 mg orally three times daily, starting on the first day of taxane-based chemotherapy and continuing until chemotherapy completion) or no routine mecobalamin prophylaxis. The primary endpoint is the cumulative incidence of grade ≥2 CIPN (CTCAE v6.0) from randomization to the end of chemotherapy.
Secondary endpoints include measures of CIPN onset and severity, patient-reported outcomes (PROs), chemotherapy delivery, and safety. Study assessments are conducted at baseline and during each chemotherapy cycle.
- Being tested
- Mecobalamin
- Keywords
- Chemotherapy induced peripheral neuropathy, Mecobalamin, Taxane, Prevention
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Secondary outcomes (9)
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).
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
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).
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
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).
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
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).
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Changes in EORTC QLQ-CIPN20 scores over time
The European Organisation for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20-item questionnaire (EORTC QLQ-CIPN20) is a validated patient-reported outcome instrument assessing CIPN-related symptoms and functional impairment. It includes 20 items covering sensory, motor, and autonomic symptoms, each rated on a 4-point Likert scale. Raw scores are linearly transformed to 0 to 100 points according to the EORTC scoring manual; higher scores indicate worse symptom burden and functional limitations. The questionnaire will be administered at multiple time points to characterize the trajectory of CIPN during and after chemotherapy.
Measured: Baseline; during each chemotherapy cycle; end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.
Changes in EQ-5D-5L scores over time
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized instrument for measuring health-related quality of life. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five levels. EQ-5D-5L responses will be converted to a single utility index score using the China EQ-5D-5L value set (1 = full health; 0 = dead; values may be < 0); higher index scores indicate better health. The EQ-5D-5L also includes a vertical visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health); higher VAS scores indicate better self-rated health. Both the index score and VAS score will be assessed at multiple time points to evaluate changes in health-related quality of life during and after chemotherapy.
Measured: Baseline; mid-treatment (at the midpoint of planned chemotherapy cycles, up to 12 weeks), end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.
Proportion of participants with taxane chemotherapy dose modification due to CIPN
Defined as the proportion of participants who have taxane dose reduction, dose delay, or treatment discontinuation attributable to CIPN during the taxane chemotherapy period.
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Relative dose intensity (RDI) of taxane chemotherapy
Defined as the relative dose intensity of taxane chemotherapy over the planned treatment period (actual dose intensity relative to the protocol/planned dose intensity), summarized for each participant.
Measured: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of AEs and SAEs occurring during the study.
Measured: From randomization through 6 months after chemotherapy completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Feb 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghai Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongqiuxia, Qinghai Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423390
- Sponsor's protocol ID
- KY-2025-214
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07423390
- Acronym / sponsor ID
- KY-2025-214
- Keywords
- Chemotherapy induced peripheral neuropathy, Mecobalamin, Taxane, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Qinghai Red Cross HospitalUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter, open-label randomized controlled trial to evaluate oral mecobalamin for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with solid tumors receiving taxane-based chemotherapy. Participants are assigned to receive prophylactic mecobalamin (0.5 mg orally three times daily, starting on the first day of taxane-based chemotherapy and continuing until chemotherapy completion) or no routine mecobalamin prophylaxis. The primary endpoint is the cumulative incidence of grade ≥2 CIPN (CTCAE v6.0) from randomization to the end of chemotherapy.
Secondary endpoints include measures of CIPN onset and severity, patient-reported outcomes (PROs), chemotherapy delivery, and safety. Study assessments are conducted at baseline and during each chemotherapy cycle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mecobalamin Prophylaxis | Experimental | Drug: MecobalaminParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MecobalaminOral 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. | Drug | Mecobalamin Prophylaxis |
Primary outcome
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN)
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
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).
9 secondary outcomes
Cumulative incidence of any grade CIPN
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Median time to first occurrence of grade ≥2 CIPN
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Cumulative incidence of grade 2 CIPN
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Cumulative incidence of grade ≥3 CIPN
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Changes in EORTC QLQ-CIPN20 scores over time
Time frame: Baseline; during each chemotherapy cycle; end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.
Changes in EQ-5D-5L scores over time
Time frame: Baseline; mid-treatment (at the midpoint of planned chemotherapy cycles, up to 12 weeks), end of chemotherapy (up to 24 weeks); and 1 week, 1 month, and 6 months after chemotherapy completion.
Proportion of participants with taxane chemotherapy dose modification due to CIPN
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Relative dose intensity (RDI) of taxane chemotherapy
Time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From randomization through 6 months after chemotherapy completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mecobalamin in people with Peripheral Neuropathy Due to Chemotherapy and Peripheral Neuropathy, Chemotherapy-induced, run by Qinghai Red Cross Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao, Dr (869716230893, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN) (time frame: From randomization up to 24 weeks (maximum planned chemotherapy duration).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.