DOI: 10.5061/dryad.gmsbcc31k
title: Data from: Effect of methylcobalamin on capecitabine-induced hand-foot syndrome in patients with HER2-negative early breast cancer: A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

description: Our objective was to evaluate whether methylcobalamin could effectively
 and safely prevent hand-foot syndrome (HFS) in human epidermal growth
 factor receptor 2 (HER2)-negative early breast cancer (EBC) patients
 receiving adjuvant capecitabine treatment. We conducted a multicentre,
 double-blind, randomised, placebo-controlled, phase 3 trial. The trials
 were conducted across seven hospitals in China between January 2022 and
 February 2024. Study participants were women aged 18 to 75 years with
 pathologically confirmed HER2-negative EBC who were scheduled to receive
 adjuvant capecitabine therapy. Eligible patients were randomly assigned in
 a 1:1 ratio to receive methylcobalamin at a dose of 0.5mg orally, three
 times daily, or a placebo for a maximum of 24 weeks. The primary endpoint
 was the incidence of grade ≥2 HFS at any time of the first occurrence
 during capecitabine treatment in the intention-to-treat analysis. 234
 patients were randomly assigned to receive methylcobalamin (n=117) or
 placebo (n=117), who were included in the intention-to-treat analysis and
 safety analysis. The grade ≥2 HFS occurred in 17 (14.5%) of 117 patients
 with methylcobalamin versus 34 (29.1%) of 117 patients with placebo (risk
 difference −14.5%, 95% confidence interval −24.9% to −4.1%; one-side
 P=0.003). The rate of HFS-related reduction or discontinuation of
 capecitabine was 7.7% (9 of 117) in the methylcobalamin group and 13.7%
 (16 of 117) in the placebo group (risk difference −6.0%, 95% confidence
 interval −13.9% to 1.9%). Two groups showed similar incidence of any other
 adverse events (88 [75.2%] in the methylcobalamin group and 95 [81.2%] in
 the placebo group). No methylcobalamin-specific adverse events were
 observed. Oral methylcobalamin, compared to placebo, significantly lowered
 the severity of HFS by reducing the incidence of grade ≥2 HFS without
 unexpected safety concerns in women with HER2-negative EBC receiving
 adjuvant capecitabine treatment. The findings support the use of
 methylcobalamin to prevent capecitabine-associated severe HFS in this
 patient population. Trial is registered with ClinicalTrials.gov as
 NCT05165069.
description: # Data from: Effect of methylcobalamin on capecitabine-induced hand-foot
 syndrome in patients with HER2-negative early breast cancer: A
 multicentre, double-blind, randomised, placebo-controlled, phase 3 trial
 Dataset DOI: [10.5061/dryad.gmsbcc31k](10.5061/dryad.gmsbcc31k) ##
 Description of the data and file structure This dataset is the raw data
 for the Glorious trial, which aimed to verify the efficacy and safety of
 methylcobalamin in preventing grade 2 or 3 HFS as compared with placebo
 among patients with HER2-negative EBC receiving adjuvant capecitabine
 treatment. Assessment through the phase 3, multicentre,
 placebo-controlled, double-blind, randomized design, and corresponds to
 the paper entitled "Effect of methylcobalamin on capecitabine-induced
 hand-foot syndrome in patients with HER2-negative early breast cancer: a
 multicentre, double-blind, randomised, placebo-controlled, phase 3
 trial". ### Files and variables #### File: Anonymised_data.xlsx
 **Description:** Raw data for the Glorious study ##### Variables * ID:
 Identification number of the participants (anonymized code) * outcome: HFS
 grade (0=grade 0-1; 1=grade 2-3) * site: Identification number of the
 study centres (anonymized code) * treatment: 0=placebo; 1=methylcobalamin
 * ages: participants’ age * age: 0=less than 60 years; 1=≥60 years * men:
 participants’ menopausal status (0=pre; 1=post) * tnm: participants’ TNM
 stage of breast cancer (1=stage-I; 2=stage-II; 3=stage-III) * hr:
 participants’ hormone receptor status of breast cancer (0=negative;
 1=positive) * chemo: participants’ previously receiving with chemotherapy
 (0=without; 1=anthracycline and taxane; 2=taxane) *
 Capecitabine_start_dosage: participants’ capecitabine start dosage
 (mg/day) * cap: participants’ capecitabine start dosage, mg/day (0=≤3000;
 1=&gt;3000) * HFS_grade_by_doctor1: the highest grade evaluated by one
 experienced dermatologists according the NCI-CTCAE version 5.0 *
 HFS_grade_by_doctor2: the highest grade evaluated by another experienced
 dermatologists according the NCI-CTCAE version 5.0 * Final_HFS_grade: the
 highest grade comprehensively evaluated by two experienced dermatologists
 according the NCI-CTCAE version 5.0 * HFS_grade_at_cycle1: the highest
 grade according the NCI-CTCAE version 5.0 * HFS_grade_at_cycle2: the
 highest grade according the NCI-CTCAE version 5.0 * HFS_grade_at_cycle3:
 the highest grade according the NCI-CTCAE version 5.0 *
 HFS_grade_at_cycle4: the highest grade according the NCI-CTCAE version 5.0
 * HFS_grade_at_cycle5: the highest grade according the NCI-CTCAE version
 5.0 * HFS_grade_at_cycle6: the highest grade according the NCI-CTCAE
 version 5.0 * HFS_grade_at_cycle7: the highest grade according the
 NCI-CTCAE version 5.0 * HFS_grade_at_cycle8: the highest grade according
 the NCI-CTCAE version 5.0 *
 HFS_related_reduction_or_discontinuation_of_capecitabine: NA=no; 25=dose
 reduction of 25%; 50=dose reduction of 50%; 100=dose discontinuation *
 Non_HFS_related_reduction_or_discontinuation_of_capecitabine: NA=no;
 25=dose reduction of 25%; 50=dose reduction of 50%; 100=dose
 discontinuation * Initiation_day_of_grade_2_and_3_HFS: the initiation of
 grade 2 or 3 HFS of participants (days); Note: NA= not applicable as no
 grade 2 or 3 HFS occured * Compliance_of_methylcobalamin_or_placebo:
 number of tablets taken/expected number of tablets to be taken×100% *
 Randomization_time: the time of randomization of participants *
 DFS_follow_up_time: the time of recurrence, death from any cause, or last
 follow-up time of participants * OS_follow_up_time: the time of death from
 any cause or last follow-up time of participants *
 Recurrence_or_death_status: 0=no; 1=yes * Death_status: 0=no; 1=yes *
 HF_QoL_at_baseline: the total scores evaluated by the HF-QoL daily
 activity questionnaire; Note: NA= not available as the patient not
 completing the questionnaire * QLQ_C30_at_baseline: the total scores
 evaluated by the QLQ_C30 questionnaire; Note: NA= not available as the
 patient not completing the questionnaire * QLQ_BR23_at_baseline: the total
 scores evaluated by the QLQ_BR23 questionnaire; Note: NA= not available as
 the patient not completing the questionnaire *
 HF_QoL_at_the_end_of_cycle_4_of_capecitabine_treatment: the total scores
 evaluated by the HF-QoL daily activity questionnaire; Note: NA= not
 available as the patient not completing the questionnaire *
 QLQ_C30_at_the_end_of_cycle_4_of_capecitabine_treatment: the total scores
 evaluated by the QLQ_C30 questionnaire; Note: NA= not available as the
 patient not completing the questionnaire *
 QLQ_BR23_at_the_end_of_cycle_4_of_capecitabine_treatment: the total scores
 evaluated by the QLQ_BR23 questionnaire; Note: NA= not available as the
 patient not completing the questionnaire *
 HF_QoL_at_the_end_of_capecitabine_treatment: the total scores evaluated by
 the HF-QoL daily activity questionnaire; Note: NA= not available as the
 patient not completing the questionnaire *
 QLQ_C30_at_the_end_of_capecitabine_treatment: the total scores evaluated
 by the QLQ_C30 questionnaire; Note: NA= not available as the patient not
 completing the questionnaire *
 QLQ_BR23_at_the_end_of_capecitabine_treatment: the total scores evaluated
 by the QLQ_BR23 questionnaire; Note: NA= not available as the patient not
 completing the questionnaire * Diarrhoea: the highest grade according the
 National Cancer Institute Common Terminology Criteria for Adverse Events
 (NCI-CTCAE) version 5.0 * Nausea: the highest grade according the
 NCI-CTCAE version 5.0 * Fatigue: the highest grade according the NCI-CTCAE
 version 5.0 * Stomatitis: the highest grade according the NCI-CTCAE
 version 5.0 * Vomiting: the highest grade according the NCI-CTCAE version
 5.0 * Leukopenia: the highest grade according the NCI-CTCAE version 5.0 *
 Neutropenia: the highest grade according the NCI-CTCAE version 5.0 *
 Anaemia: the highest grade according the NCI-CTCAE version 5.0 * Platelet
 count decreased: the highest grade according the NCI-CTCAE version 5.0 *
 Lymphopenia: the highest grade according the NCI-CTCAE version 5.0 * AST
 increased: the highest grade according the NCI-CTCAE version 5.0 * ALT
 increased: the highest grade according the NCI-CTCAE version 5.0 *
 Bilirubin level increased: the highest grade according the NCI-CTCAE
 version 5.0 * ALP increased: the highest grade according the NCI-CTCAE
 version 5.0 * Creatinine increased: the highest grade according the
 NCI-CTCAE version 5.0 ## Code/software R studio software (version 4.2.2 or
 later) ## Human subjects data Ethics approval was obtained from the ethics
 committee of each hospital and all participants signed written informed
 consent. The study was conducted in accordance with the Declaration of
 Helsinki. All information that might disclose the identity of the subjects
 has been removed.