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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025890
Receipt No. 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

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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
Email 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
Email tanaka@taiiku.tsukuba.ac.jp

Sponsor
Institute St. Luke's International Hospital
Department of Breast Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029765

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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