UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002932 |
|---|---|
| Receipt number | 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 09:58:24 |
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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
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
hiwata@aichi-cc.jp
Sponsor or person
Institute
Tokai Breast Cancer Clinical Research Group (TBCRG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003567
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