UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007314 |
|---|---|
| Receipt number | R000008625 |
| Scientific Title | The effect of pyridoxine for prevention of hand-foot syndrome in colon cancer patients with adjuvant chemotherapy using capecitabine: a randomized study |
| Date of disclosure of the study information | 2012/02/17 |
| Last modified on | 2012/02/16 19:59:37 |
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Basic information
Public title
The effect of pyridoxine for prevention of hand-foot syndrome in colon cancer patients with adjuvant chemotherapy using capecitabine: a randomized study
Acronym
The effect of pyridoxine for prevention of hand-foot syndrome
Scientific Title
The effect of pyridoxine for prevention of hand-foot syndrome in colon cancer patients with adjuvant chemotherapy using capecitabine: a randomized study
Scientific Title:Acronym
The effect of pyridoxine for prevention of hand-foot syndrome
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of the pyridoxine for prevention of hand- foot syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of at least grade 2 HFS when comparing the groups.
Key secondary outcomes
periods of safety profile (rate and severity of adverse events), cumulative incidence of HFS.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were prescribed pyridoxine 20 mg three times per day by closed envelope randomization.
Interventions/Control_2
no treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologicallyconfirmed colorectal cancer (adenocarcinoma). (15) Histological stage III colon cancer or rectosigmoid cancer resected with D2 or more lymph node dissection. (4) Age 20–75 years old. (5) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (6) No prior chemotherapy or radiotherapy for target disease. (7) Oral intake is possible. (8) Preservation of primary organ function [white blood cell (WBC) count ≥3,000/mm3 and <12,000/mm3, neutrophil count ≥1,500/mm3, haemoglobin ≥9.0 g/dL, platelet count ≥100,000/mm3, serum creatinine <1.5 mg/dl, serum total bilirubin <1.5 mg/dl, aspartate aminotransferase, alanine aminotransferase (ALT) <100 IU/L. (9) Able to start protocol treatment within 8 weeks of surgical procedure. (10) After basic screening, informed consent to participate in the study was obtained from patients.
Key exclusion criteria
(1) Pregnant or lactating, or planning to become pregnant. (15) History of hypersensitivity or severe adverse reaction to fluoropyrimidines. (3) Serious concurrent disease [including interstitial pneumonia, pulmonary fibrosis, intestinal paralysis, ileus, poorly controlled diabetes, liver cirrhosis or hepatitis (type B or C), history of myocardial infarction or unstable angina within past 6 months]. (4) Active multiple primary cancer (disease-free less than 5 years). (5) Concurrent infectious disease. (6) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Ota |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
81457872650
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University
Division name
Gastroenterological Surgery
Zip code
Address
TEL
045-787-2650
Homepage URL
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 16 | Day |
Last modified on
| 2012 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008625
