UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011772 |
|---|---|
| Receipt number | R000012453 |
| Scientific Title | Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) in patients of metastatic breast cancer |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2013/09/15 01:01:00 |
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Basic information
Public title
Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) in patients of metastatic breast cancer
Acronym
Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) induced by capecitabine in patients of metastatic breast cancer
Scientific Title
Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) in patients of metastatic breast cancer
Scientific Title:Acronym
Clinical trial to assess the efficacy of adapalene for hand-foot syndrome (HFS) induced by capecitabine in patients of metastatic breast cancer
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of topical application of adapalene for hand-foot syndrome (HFS) induced by capecitabine in patients of metastatic breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Inhibition ratio of HFS on the applied hand and foot of adapalene to the opposite sides
Inhibiton ratio of HFS: number of cases which have successful treatment with adapalene / number of cases with HFS induced by capecitabine
Key secondary outcomes
Percentage of patients with hand-foot syndrome on the applied hand and foot of adapalene or on the opposite side
Time to the onset of hand-foot syndrome according to grade of HFS
Progression-free Survival (PFS)
Overall Response Rate (ORR)
Incidence of an adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adapalene is applied to the unilateral of hand and foot daily during capecitabine administration.
Interventions/Control_2
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
Scheduled for capecitabine therapy and satisfy the following criteria:
1)Signed informed consent of the patient for the registration.
2)Histological confirmed invasive breast cancer
3)Age: At least 20 years of age
4)ECOG performance status 0 – 2
5)Adequate oral intake
6)Patients without pervious hypersensitive reactions to medicines for external application
7)Expected to survival time: more than 3 months
8)Not received prior chemotherapy with capecitabine
9)Adequate major organ function in the 21 days before entry
WBC count 3,000 / mm3 or more( or granulocyte count 1,500 / mm3 or more
Platelet 75,000/mm3 or more
Hb 9.0g/dl or more
AST(GOT) , ALT(GPT),and ALP less than 2.5-times the upper limit of normal
(If a patient have liver metastasis, AST(GOT) , ALT(GPT),and ALP less than 5-times the upper limit of normal)
Total-bilirubin 1.5 mg/dL or less
serum creatinine 1.5 mg/dL or less
Key exclusion criteria
1)Past history of allergic reaction
2)Active secondary malignancies
3)Pregnancy or suspected pregnancy
4)Uncontralled severe infection
5)severe complications (uncontrolled hypertension, angina pectoris, congestive heart disease, liver failure, prior myocardial infarction in less than a year, arrhythmia requiring treatment, or bleeding tendency)
6)Dyspnea requiring oxygen therapy because of interstitial pneumonia or pulmonary fibrosis
7)Symptomatic brain metastasis
8)Uncontrolled diabetes mellitus
9)Severe pleural effusion or ascites
10)Physician judged improper to entry this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Inokuchi |
Organization
Kanazawa University
Division name
Department of gastroenterologic and breast surgery
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2362
inokuchi@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Inokuchi |
Organization
Kanazawa University
Division name
Department of gastroenterologic and breast surgery
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2362
Homepage URL
inokuchi@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of gastroenterologic and breast surgery
Kanazawa University,School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of gastroenterologic and breast surgery
Kanazawa University,School of Medicine
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
| 2013 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2013 | Year | 09 | Month | 15 | Day |
Last modified on
| 2013 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012453
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| Registered date | File name |
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