UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combined diet and exercise intervention among breast cancer survivors
Title of the study (Brief title)	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	Kiyoji Tanaka
Organization	University of Tsukuba
Division name	Faculty of Physical Education
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-2111
Email	tanaka@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Kiyoji Tanaka
Organization	University of Tsukuba
Division name	Faculty of Physical Education
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Combined exercise plus diet program may contribute to improvement in cardiorespiratory fitness, QoL, and body weight compared with control group.
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/icdr_e/ctr_view.cgi?recptno=R000029765