UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052008 |
|---|---|
| Receipt number | R000059363 |
| Scientific Title | Exercise support efforts for Japanese breast cancer survivors: accumulation of evidence on effects of home-based exercise interventions. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/02/25 12:18:18 |
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Basic information
Public title
Effects of exercise on treatment-related adverse effects in breast cancer patients receiving adjuvant hormonal therapy.
Acronym
Randomized controlled trial for the effects of exercise in breast cancer patients.
Scientific Title
Exercise support efforts for Japanese breast cancer survivors: accumulation of evidence on effects of home-based exercise interventions.
Scientific Title:Acronym
Exercise support efforts for Japanese breast cancer survivors: accumulation of evidence on effects of home-based exercise interventions.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study conducts a randomized controlled the effects of home-based exercise on treatment-related adverse effects in breast cancer patients receiving adjuvant hormonal therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer-related fatigue score (EORTC QLQ-FA12)
Key secondary outcomes
QOL assessment, physical fitness, body composition, bone mineral density
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interventions: Aerobic exercise (Nordic walking), resistance exercise (body mass based squat and rubber band training), inpact loading exercise (exercise to increase bone mineral density)
Interventions/Control_2
Control: No exercise (usual care only)
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
Patients who receive adjuvant hormonal therapy for over one year at Sagara Hospital, Kagoshima University Hospital and Kaneko Clinic.
Patients who gave written informed consent.
Key exclusion criteria
The patients who is:
1. prohibited from exercise by a physician
2. with severe lymphedema
3. with bone metastatic disease
4. with osteoporosis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Fujita |
Organization
National Institute of Fitness and Sports in KANOYA
Division name
Faculty of Sports and Life Science
Zip code
8912393
Address
1 Shiromizu-cho, Kanoya city, Kagoshima, Japan
TEL
0994-46-5014
fujita@nifs-k.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Fujita |
Organization
National Institute of Fitness and Sports in KANOYA
Division name
Faculty of Sports and Life Science
Zip code
8912393
Address
1 Shiromizu-cho, Kanoya city, Kagoshima, Japan
TEL
0994-46-5014
Homepage URL
fujita@nifs-k.ac.jp
Sponsor or person
Institute
National Institute of Fitness and Sports in KANOYA
Institute
Department
Personal name
Eiji Fujita
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital Clinical Research Management Center
Address
8-35-1 Sakuragaoka, Kagoshima city, Kagoshima, Japan
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.ac.jp
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
相良病院（鹿児島県）、鹿児島大学病院（鹿児島県）、かねこクリニック（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ongoing
Management information
Registered date
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059363
