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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011772
Receipt No. 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

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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 &#8211; 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
Email 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
Email inokuchi@staff.kanazawa-u.ac.jp

Sponsor
Institute Department of gastroenterologic and breast surgery
Kanazawa University,School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012453

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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