SarcopeniaNCT04037488
Changes in Body Composition With Patients Under Androgen Deprivation Therapy
An observational study of Sarcopenia and Prostate Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Sarcopenia, Prostate Cancer
- What is being tested?
- Inbody 320
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2019to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with long-term (more than 2 year) androgen deprivation therapy for treatment of prostate cancer, without any other malignancy.
Who may be able to join
- Age over 20 year-old
- Patient with ECOG-PS 0 to 2
- Prostate cancer patients
- Considered Androgen deprivation therapy with any cause
- Patient agreed with informed consent of this study
Who cannot join
- History of previous ADT
- Planned intermittent treatment or short term ADT (less than 2 year)
- Contraindication of ADT
- Severe cognitive impairment, who cannot eligible for survey
- Secondary malignancy
- Patient cannot perform InBody test because of physical or underlying disease.
Trial locations and contacts
1 site in 1 country.
Chang Wook Jeong, MD. PHD. contact
About this study
Official title: Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy
This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT).
Read the detailed description
Sarcopenia, decrease lean body mass (LBM) is the well-known parameter which negatively related to physical activity, morbidity and patients survival. Aging and decreased blood androgen level are well known risk factors of sarcopenia in male population.
Androgen deprivation therapy (ADT) is commonly performed in advanced or recurred prostate cancer patient and lead to accelerating decreasing blood androgen level. The previous studies defined the sarcopenia after ADT by calculated the (muscle component area) / (total body area) on computed tomography (CT) scan. However, CT scan is not recommended for routine follow up examination of ADT patients thus this measurement of sarcopenia has limitation on clinical usage.
This study using Inbody 320 for measure body composition. Inbody 320 based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Inbody measurement show precision accuracy and safety on body composition measurement, thus it frequently used in studies of obesity, nutrition and sports fields.
We calculating the total skeletal muscle mass (SMM), skeletal muscle index(SMI), relative skeletal muscle mass index (RASM), fat body mass (FBM), body mass index (BMI), body fat percentage, body water content, and edema value by Inbody 320 in the patients who treated by ADT in prostate cancer patients. Enrolled patients check the body composition parameters at the baseline (before ADT) and after ADT 3,6,12,18,24 months.
We prospectively measuring the 2 years changes of body composition and sarcopenia after ADT treatment. Patients characteristics (Age, underlying disease), Prostate cancer status (PSA level, Gleason grade group, initial treatment), ADT methods characters (timing, type) and oncological outcome (Recurrence, Metastasis, Castration resistance) were measuring in the cohort population.
Post hoc analysis were performed in the timing (initial, salvage or adjuvant) or type (LHRH agonist, Antiandrogen or surgical castration) of ADT for development of sarcopenia. Sub-arm analysis were performed for assessing that effect of presence of sarcopenia on oncological outcome and functional outcomes after ADT.
- Conditions
- Sarcopenia, Prostate Cancer
- Being tested
- Inbody 320
- Keywords
- Androgen deprivation therapy, Prostate cancer, Body composition, Lean body mass
- Medical subject headings
- Sarcopenia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inbody 320Diagnostic test
Also called Body composition change
Total Skeletal muscle mass (SMM), Skeletal muscle index (SMI), Relative Skeletal muscle mass index (RASM), Fat body mass (FBM), Body mass index (BMI), Body fat percentage, Body water content, Edema Value were calculated by Inbody 320
| Study group | Role | What they receive |
|---|---|---|
| Cohort: ADT patients | All enrolled patient data entered in single group cohort. All patient who started androgen deprivation therapy for prostate cancer can included this cohort by following inclusion and exclusion criteria. We do not planned any intervention on this cohort. We measuring changes of body composition by Inbody 320 in the planned follow-up period.
We planned sub-group analysis for timing of intervention (Intervention 1) , ADT type(Intervention 2), LHRH agonist type(Intervention 3), patients age(Intervention 4), initial PSA level (Intervention 5) and Gleason Grade Group (Intervention 6). Receives: Diagnostic Test: Inbody 320 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition change-Skeletal muscle index (SMI)
Lean body mas (kg) / body weight (kg) x 100 (%)
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Body composition change-Body mass index (BMI)
{body weight (kg)} / {height (m)^2}
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Body composition change-Relative skeletal muscle index (RASM)
Sum of skeletal muscle mass in limbs (kg) / {height (m)^2}
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Body composition change - fat body mass (FBM)
fat body mass (FBM) calculated by Inbody 320
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Secondary outcomes (4)
Laboratory changes-PSA
PSA level changes
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Laboratory changes-Testosterone
Testosterone level changes
Measured: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Oncologic outcomes - recurrence
Any local or distance recurrence
Measured: Up to 24 weeks
Oncologic outcomes - survival
Any cause of death
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startAug 2019 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HanAll BioPharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chang Wook Jeong, MD. PHD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037488
- Sponsor's protocol ID
- SNUH-URO-2018-01
- Status last verified
- Sep 2018
- First submitted
- 29 Nov 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT04037488
- Acronym / sponsor ID
- SNUH-URO-2018-01
- Conditions
- Sarcopenia, Prostate Cancer
- Keywords
- Androgen deprivation therapy, Prostate cancer, Body composition, Lean body mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HanAll BioPharma Co., Ltd.
- Study start
- Aug 2019 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT).
Detailed description
Sarcopenia, decrease lean body mass (LBM) is the well-known parameter which negatively related to physical activity, morbidity and patients survival. Aging and decreased blood androgen level are well known risk factors of sarcopenia in male population.
Androgen deprivation therapy (ADT) is commonly performed in advanced or recurred prostate cancer patient and lead to accelerating decreasing blood androgen level. The previous studies defined the sarcopenia after ADT by calculated the (muscle component area) / (total body area) on computed tomography (CT) scan. However, CT scan is not recommended for routine follow up examination of ADT patients thus this measurement of sarcopenia has limitation on clinical usage.
This study using Inbody 320 for measure body composition. Inbody 320 based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Inbody measurement show precision accuracy and safety on body composition measurement, thus it frequently used in studies of obesity, nutrition and sports fields.
We calculating the total skeletal muscle mass (SMM), skeletal muscle index(SMI), relative skeletal muscle mass index (RASM), fat body mass (FBM), body mass index (BMI), body fat percentage, body water content, and edema value by Inbody 320 in the patients who treated by ADT in prostate cancer patients. Enrolled patients check the body composition parameters at the baseline (before ADT) and after ADT 3,6,12,18,24 months.
We prospectively measuring the 2 years changes of body composition and sarcopenia after ADT treatment. Patients characteristics (Age, underlying disease), Prostate cancer status (PSA level, Gleason grade group, initial treatment), ADT methods characters (timing, type) and oncological outcome (Recurrence, Metastasis, Castration resistance) were measuring in the cohort population.
Post hoc analysis were performed in the timing (initial, salvage or adjuvant) or type (LHRH agonist, Antiandrogen or surgical castration) of ADT for development of sarcopenia. Sub-arm analysis were performed for assessing that effect of presence of sarcopenia on oncological outcome and functional outcomes after ADT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort: ADT patients | – | Diagnostic Test: Inbody 320All enrolled patient data entered in single group cohort. All patient who started androgen deprivation therapy for prostate cancer can included this cohort by following inclusion and exclusion criteria. We do not planned any intervention on this cohort. We measuring changes of body composition by Inbody 320 in the planned follow-up period. We planned sub-group analysis for timing of intervention (Intervention 1) , ADT type(Intervention 2), LHRH agonist type(Intervention 3), patients age(Intervention 4), initial PSA level (Intervention 5) and Gleason Grade Group (Intervention 6). |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with long-term (more than 2 year) androgen deprivation therapy for treatment of prostate cancer, without any other malignancy.
Key inclusion criteria (5 listed)
- Age over 20 year-old
- Patient with ECOG-PS 0 to 2
- Prostate cancer patients
- Considered Androgen deprivation therapy with any cause
- Patient agreed with informed consent of this study
Key exclusion criteria (6 listed)
- History of previous ADT
- Planned intermittent treatment or short term ADT (less than 2 year)
- Contraindication of ADT
- Severe cognitive impairment, who cannot eligible for survey
- Secondary malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inbody 320Also: Body composition changeTotal Skeletal muscle mass (SMM), Skeletal muscle index (SMI), Relative Skeletal muscle mass index (RASM), Fat body mass (FBM), Body mass index (BMI), Body fat percentage, Body water content, Edema Value were calculated by Inbody 320 | Diagnostic test | Cohort: ADT patients |
Primary outcome
Body composition change-Skeletal muscle index (SMI)
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Lean body mas (kg) / body weight (kg) x 100 (%)
Body composition change-Body mass index (BMI)
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
{body weight (kg)} / {height (m)^2}
Body composition change-Relative skeletal muscle index (RASM)
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Sum of skeletal muscle mass in limbs (kg) / {height (m)^2}
Body composition change - fat body mass (FBM)
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
fat body mass (FBM) calculated by Inbody 320
4 secondary outcomes
Laboratory changes-PSA
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Laboratory changes-Testosterone
Time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Oncologic outcomes - recurrence
Time frame: Up to 24 weeks
Oncologic outcomes - survival
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Related trials for Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Wook Jeong, MD. PHD. contact
Chang Wook Jeong, MD. PHD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Prostate Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jungyo Suh, MD. (+82-10-5190-8098, crazyslime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition change-Skeletal muscle index (SMI) (time frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.