UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000002932
Receipt No. R000003567
Scientific Title Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Date of disclosure of the study information 2010/01/01
Last modified on 2019/06/30 (Ver. 9)

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Basic information
Public title Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Acronym Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Scientific Title Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Scientific Title:Acronym Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Region
Japan

Condition
Condition Locally advanced or metastatic breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This randomized phase II trial evaluates pridoxine for preventing of hand-foot syndrome (HFS) compared with no pyridoxine in breast cancer patients treated with capacitabine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Time to the onset of HFS (Grade2 or 3)
Key secondary outcomes Incidence of HFS (any Grade)
Time to the onset of HFS (any Grade)
Incidence of HFS by chemotherapy type
Treatment duration and dosage of Capecitabine administration
Safety
Quality of life by Skindex29
Finger pressure by pinch meter

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 No prodpxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy
Interventions/Control_2 Pridoxine group: Patients receiving capecitabine mono therapy or capecitabine combination chemotherapy with pyridoxal 60mg po daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Diagnosis of advanced breast cancer
2. 20 years old or more
3. ECOG performance status 0-1
4. Can eat
5. Life expectancy more than 3 months
6. Written informed consents
7. Sufficient organ functions
Key exclusion criteria 1. History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency
2. Capecitabine used prior chemotherapy
3. History of drug hypersensitivity not suitable for this study
4. Uncontrolled serious complications
5. Multiple primary cancer within 5 years
6. Pregnant women or possibly pregnant women
7. Other conditions not suitable for this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Toyama
Organization Nagoya City University Hospital
Division name Breast Surgery
Zip code 467-8601
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
TEL 052-851-5511
Email toyamat-ncu@umin.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Ohmori
Organization Tokai Breast Cancer Clinical Research Group (TBCRG)
Division name Office
Zip code 464-8681
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan
TEL 052-762-6111
Homepage URL
Email hiwata@aichi-cc.jp

Sponsor
Institute Tokai Breast Cancer Clinical Research Group (TBCRG)
Institute
Department

Funding Source
Organization Comprehensive Support Project for Oncological Research (CSPOR)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya City University Hospital
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel 0528515511
Email toyamat-ncu@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 01 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/29948956
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29948956
Number of participants that the trial has enrolled 135
Results 
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.
Results date posted
2019 Year 06 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
Participant flow 
From July 2010 to December 2012, 135 patients were enrolled to the study: 67 were randomly assigned to the pyridoxine group, and 68 to the no pyridoxine group. Two patients did not start protocol treatment; 133 patients, therefore, constituted the full analysis set (Fig. 1). Median followup was 4.4 and 2.9 months for the pyridoxine and the no pyridoxine groups, respectively. The patient characteristics
are shown in Table 2. Baseline demographic characteristics were generally well balanced. The median age among groups with and without pyridoxine was 60 and 61 years, respectively. Approximately one-quarter of the patients in each group had received no previous chemotherapy for advanced or metastatic breast cancer, while one-third of the patients in each group had received the first-line chemotherapy. The rate of prior medication with taxanes, including adjuvant therapy, was 68% in the pyridoxine group and 73% in the no pyridoxine group. The rate of grade 0 and 1 HFS at randomization was 90.9% (60 patients) and 9.1% (6 patients) in the
pyridoxine group, respectively, and was 92.5% (62 patients) and 7.5% (5 patients) in the no pyridoxine group, respectively. Approximately 80% of patients received capecitabine monotherapy in each group.
Adverse events 
Leukopenia has not previously been reported
as an adverse event related to pyridoxine therapy. In this study, the median number of treatment cycles of capecitabine-containing chemotherapy was 5.5 and 4.0 in the pyridoxine and no pyridoxine groups, respectively. Therefore, the increased incidence of leukopenia in the pyridoxine group may be attributable to a longer exposure to chemotherapy.
Outcome measures 
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no
pyridoxine groups, respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 11 Month 09 Day
Date of IRB
2009 Year 10 Month 01 Day
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 22 Day
Last modified on
2019 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003567