Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Chemotherapy-induced
Conditions
Keywords
Chemotherapy induced peripheral neuropathy, Mecobalamin, Taxane, Prevention
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.
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.
Interventions
DRUGMecobalamin
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.
Sponsors
Qinghai Red Cross Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 to 80 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of any grade CIPN | From randomization up to 24 weeks (maximum planned chemotherapy duration). | 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). |
| Median time to first occurrence of grade ≥2 CIPN | From randomization up to 24 weeks (maximum planned chemotherapy duration). | 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). |
| Cumulative incidence of grade 2 CIPN | 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). |
| Cumulative incidence of grade ≥3 CIPN | From randomization up to 24 weeks (maximum planned chemotherapy duration). | 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). |
| 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. | 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. |
| Changes in EQ-5D-5L scores over time | 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. | 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. |
| Proportion of participants with taxane chemotherapy dose modification due to CIPN | From randomization up to 24 weeks (maximum planned chemotherapy duration). | Defined as the proportion of participants who have taxane dose reduction, dose delay, or treatment discontinuation attributable to CIPN during the taxane chemotherapy period. |
| Relative dose intensity (RDI) of taxane chemotherapy | From randomization up to 24 weeks (maximum planned chemotherapy duration). | 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. |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From randomization through 6 months after chemotherapy completion. | Incidence and severity of AEs and SAEs occurring during the study. |
Countries
China
Contacts
CONTACTJiuda Zhao, Dr
Outcome results
None listed