UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057982 |
|---|---|
| Receipt number | R000066216 |
| Scientific Title | Efficacy of physical exercise on muscle mass and strength in prostate cancer patients receiving androgen deprivation therapy: A prospective study |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/27 15:39:20 |
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Basic information
Public title
Efficacy of physical exercise on muscle mass and strength in prostate cancer patients receiving androgen deprivation therapy
Acronym
Exercise in patients with prostate cancer
Scientific Title
Efficacy of physical exercise on muscle mass and strength in prostate cancer patients receiving androgen deprivation therapy: A prospective study
Scientific Title:Acronym
Efficacy of physical exercise in prostate cancer patients
Region
| Japan |
Condition
Condition
Prostate cancer patients receiving hormonal therapy (androgen deprivation therapy)
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hormone therapy (ADT) for prostate cancer rapidly reduces testosterone to castration levels, which may result in the incidence of lifestyle-related diseases such as obesity, dyslipidemia, and increased insulin resistance. Furthermore, ADT can lead to a significant reduction in muscle strength and bone mineral density, and then worsening the quality of life (QOL) among prostate cancer patients by increased risk of sarcopenia, falls, and fractures. Therefore, when ADT is administered for prostate cancer patients, it is important to prevent these serious conditions by improving diet and lifestyle habits, and appropriate exercise therapy.
The present study assesses an efficacy of a non-invasive and feasible exercise program in daily life on prevention of muscle weakness caused by ADT among
locally advanced prostate patients undergoing radical radiation therapy combined with hormone therapy (approximately 2 years of combined hormone therapy and radiation therapy) and the metastatic prostate cancer patients with ADT. This is a prospective observational study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in systemic muscle mass, Lower limb muscle mass, and grip power (items associated with sarcopenia) 3, 6, 9. 12, 18, 24, 30, and 36 months after initiation of ADT.
Key secondary outcomes
The following items before and after the start of treatment:
1. Height, weight, BMI, body fat percentage, and waist circumference
2. Locomotor syndrome test
3. Short Physical Performance Battery
4. Clinical Frailty Scale
5. Bone mineral content (evaluated at the femoral neck)
6. Skeletal muscle index at L3 level on CT (L3-SMI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
All participants are asked to perform physical exercise in their daily lives.
Physical excercise is performed as a home program. A home program includes excercises recommended by the Ministry of Health, Labor and Welfare and the Japan Orthopedic Association, as following;1.Walking of 8000 steps a day, three times per week, 2.Diary locomotor-training. All subjects were asked to keep a diary about how well they were able to perform these exercises.
Based on a diary and data of smart band, all participants are divided into three groups as following; patients who performed a lot of exercise therapy (80% or more), ones who performed it to a certain extent (40-80%), and the group who performed it very little (less than 40%). All data are compared in these three groups. Short-term efficacy (6 months) and long-term efficacy (36 months) of physical exercise are assessed.
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
Male
Key inclusion criteria
1. The patients with locally advanced prostate cancer receiving hormonal therapy and radical radiotherapy, or the patients with painless metastatic prostate cancer receiving hormonal therapy.
2. The patients with a written informed consent to attend the present study.
3. The patients aged over 20 years.
Key exclusion criteria
1. The prostate cancer therapy patients with metastatic prostate cancer and with a risk of bone fracture (bone scan index of more than 3.0% based on bone scan).
2. The patients with cardiovascular diseases, locomotor diseases, or neurologic disorders, which are not suitable for exercise therapy.
3. The patients who are deemed inappropriate by an attending doctor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Shigehara |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan
TEL
076-265-2393
kshigehara0415@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Shigehara |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1, Takaramachi. Kanazawa, Ishikawa, Japan
TEL
076-265-2393
Homepage URL
kshigehara0415@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Kanazawa University Hospital
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
Medical Ethics Committee of Kanazawa University
Address
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
Tel
076-265-2000
rinri@adm.kanazawa-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | 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
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066216
