UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025890 |
|---|---|
| Receipt number | R000029765 |
| Scientific Title | Combined diet and exercise intervention among breast cancer survivors |
| Date of disclosure of the study information | 2017/01/28 |
| Last modified on | 2017/07/31 15:02:13 |
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Basic information
Public title
Combined diet and exercise intervention among breast cancer survivors
Acronym
Combined diet and exercise intervention among breast cancer survivors
Scientific Title
Combined diet and exercise intervention among breast cancer survivors
Scientific Title:Acronym
Combined diet and exercise intervention among breast cancer survivors
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Weight gain associated risk of breast cancer and previous studies reported that there are some side effect of endocrine therapy.According to Merinda et al., combined diet-pogrom and exercise-program is effective to palliate side effect such as arthlalgia, weight-gain, physical deterioration. However, there are few study in Japan which research the effect of diet and exercise program.
This study aimed to examine that the effect of combined diet and exercise program for women during endocrine therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Body weight, body mass index, physical fitness, cancer-fatigue scale, fact-B,
Key secondary outcomes
Bone mineral density, triglyceride(TG), High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, Fasting plasma glucose, gamma-GTP, aspartate aminotransferase(AST),alanine aminotransferase (ALT), physical activity, Pain-Detect, Systolic blood pressure, Diastolic blood pressure, cognitive-function, locomotive-syndrome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
No intervention
Interventions/Control_2
This intervention consists 90 minutes nutrition education session in the hospital and 90 minutes exercise training in the sports gym.
These weekly interventions were held 12 times.
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
Female
Key inclusion criteria
These subject were breast cancer survivors with endocrine therapy
Key exclusion criteria
Patients with cognitive function
Less than 1 year after operation
in the middle of chemotherapy
metastatic breast cancer with symptoms
can't exercise because of doctors order
can't change the nutrition-balance because of doctors order
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Physical Education
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-2111
tanaka@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Physical Education
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-2111
Homepage URL
tanaka@taiiku.tsukuba.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Department of Breast Surgery
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 01 | Month | 28 | 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
Combined exercise plus diet program may contribute to improvement in cardiorespiratory fitness, QoL, and body weight compared with control group.
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
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029765
