Prostate CancerNCT01909440
Resistance Training and Protein Supplementation for Prostate Cancer Survivors
A study testing exercise intervention, nutritional supplementation and quality-of-life assessment in people with Prostate Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- exercise intervention, nutritional supplementation and quality-of-life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2013to 7 Aug 2018
- Phase
- Interventional
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with prostate cancer
- Treatment with androgen deprivation therapy (ADT) (gonadotropin-releasing hormone [GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer
- Receiving ADT for a minimum of 12 weeks before enrollment into the study
- Planned ADT for the duration of the 12-week study period
- Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies
- No opioid-requiring cancer related pain
- Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living
- Permission from treating/study physician to participate in RT
Who cannot join
- No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry)
- History of allergic reactions to whey protein
- Milk protein intolerance/allergies (lactose intolerance is acceptable)
- Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
- Recovered from major surgery within the last 6 months
- Acute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina)
Show all 9Show fewer
- Stroke within the past 2 years
- Neurologic and/or orthopedic limitations that preclude the participation in the training program (e.g. bone metastases that may pose a high risk of pathologic fracture)
- Subjects currently participating in a RT program
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
This randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the effects of progressive, structured resistance training (RT) program , with and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence additional outcomes such as physical function, quality of life (QOL) and molecular pathways that regulate skeletal muscle.
SECONDARY OBJECTIVES:
- To examine the effects of a structured RT program, with and without PS, on muscle strength, physical function, and QOL in PCS on ADT .
TERTIARY OBJECTIVES:
- To examine the effects of a progressive, structured RT program, with and without PS, on anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.
II. To examine the effects of a progressive, structured RT program, with and without PS, on bone turnover markers and bone mineral density in PCS on ADT.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
ARM II: Patients undergo total body RT and stretching as in Arm I.
ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.
ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient may undergo total body RT as in Arm 1.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Prostate Cancer
- Being tested
- exercise intervention, nutritional supplementation, quality-of-life assessment, questionnaire administration, pharmacological study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Receive whole body RT
nutritional supplementationDietary supplement
Given whey protein supplementation PO
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RT + PS) | Experimental | Patients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks. Receives: Behavioral: exercise intervention; Dietary Supplement: nutritional supplementation; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm II (total body RT) | Experimental | Patients undergo total body RT and stretching as in Arm I. Receives: Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm III (protein supplementation) | Experimental | Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I. Receives: Dietary Supplement: nutritional supplementation; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm IV (attention control) | Active comparator | Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I. Receives: Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the resistance training program with at least 80% of the sessions attended
Measured: 12 weeks
Compliance with protein supplementation
Measured: 12 weeks
Change in lean body mass
Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Measured: Baseline up to 12 weeks
Change in strength
Intent-to-treat models will be computed using repeated measures ANOVA.
Measured: Baseline up to 12 weeks
Change in quality of life
Intent-to-treat models will be computed using repeated measures ANOVA.
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study start8 Jul 2013
- Primary completion10 Mar 2017
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- E. Todd Schroeder, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909440
- Sponsor's protocol ID
- 4P-13-2
- Other IDs
- NCI-2013-01360, HS-13-00315, P30CA014089
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2013
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dawson JK, Dorff TB, Tuzon C, Rice JC, Schroeder ET, Lane CJ, Gross ME, Dieli-Conwright CM. Effect of Periodized Resistance Training on Skeletal Muscle During Androgen Deprivation Therapy for Prostate Cancer: A Pilot Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211035442. doi: 10.1177/15347354211035442.
PubMed 34301165Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
PubMed 29614993Kiwata JL, Dorff TB, Todd Schroeder E, Salem GJ, Lane CJ, Rice JC, Gross ME, Dieli-Conwright CM. A pilot randomised controlled trial of a periodised resistance training and protein supplementation intervention in prostate cancer survivors on androgen deprivation therapy. BMJ Open. 2017 Jul 10;7(7):e016910. doi: 10.1136/bmjopen-2017-016910.
PubMed 28698349
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01909440
- Acronym / sponsor ID
- 4P-13-2
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2013 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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 randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.
Detailed description
PRIMARY OBJECTIVES:
- To examine the effects of progressive, structured resistance training (RT) program , with and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence additional outcomes such as physical function, quality of life (QOL) and molecular pathways that regulate skeletal muscle.
SECONDARY OBJECTIVES:
- To examine the effects of a structured RT program, with and without PS, on muscle strength, physical function, and QOL in PCS on ADT .
TERTIARY OBJECTIVES:
- To examine the effects of a progressive, structured RT program, with and without PS, on anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.
II. To examine the effects of a progressive, structured RT program, with and without PS, on bone turnover markers and bone mineral density in PCS on ADT.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks.
ARM II: Patients undergo total body RT and stretching as in Arm I.
ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.
ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient may undergo total body RT as in Arm 1.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (RT + PS) | Experimental | Behavioral: exercise intervention, Dietary Supplement: nutritional supplementation, Procedure: quality-of-life assessment, Other: questionnaire administration, Other: pharmacological study, Other: laboratory biomarker analysisPatients undergo total body high-intensity RT thrice weekly and perform static stretching exercises after each session. Exercises progress from low intensity and high volume to higher intensity and lower volume over the course of the 12-week program. Patients also receive whey protein supplementation orally twice a day for 12 weeks. |
| Arm II (total body RT) | Experimental | Behavioral: exercise intervention, Procedure: quality-of-life assessment, Other: questionnaire administration, Other: pharmacological study, Other: laboratory biomarker analysisPatients undergo total body RT and stretching as in Arm I. |
| Arm III (protein supplementation) | Experimental | Dietary Supplement: nutritional supplementation, Procedure: quality-of-life assessment, Other: questionnaire administration, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive whey protein supplementation as in Arm I. Patients also undergo a home flexibility program 3 times per week, consisting of the same static stretching exercises performed after RT. After 12 weeks, patients may undergo the RT program as in Arm I. |
| Arm IV (attention control) | Active comparator | Procedure: quality-of-life assessment, Other: questionnaire administration, Other: pharmacological study, Other: laboratory biomarker analysisPatients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with prostate cancer
- Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies
- Permission from treating/study physician to participate in RT
Key exclusion criteria (9 listed)
- No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry)
- History of allergic reactions to whey protein
- Milk protein intolerance/allergies (lactose intolerance is acceptable)
- Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
- Recovered from major surgery within the last 6 months
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 |
|---|---|---|
| exercise interventionReceive whole body RT | Behavioural | Arm I (RT + PS), Arm II (total body RT) |
| nutritional supplementationGiven whey protein supplementation PO | Dietary supplement | Arm I (RT + PS), Arm III (protein supplementation) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (RT + PS), Arm II (total body RT), Arm III (protein supplementation), Arm IV (attention control) |
| questionnaire administrationAncillary studies | Other | Arm I (RT + PS), Arm II (total body RT), Arm III (protein supplementation), Arm IV (attention control) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (RT + PS), Arm II (total body RT), Arm III (protein supplementation), Arm IV (attention control) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (RT + PS), Arm II (total body RT), Arm III (protein supplementation), Arm IV (attention control) |
Primary outcome
Completion of the resistance training program with at least 80% of the sessions attended
Time frame: 12 weeks
Compliance with protein supplementation
Time frame: 12 weeks
Change in lean body mass
Time frame: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Change in strength
Time frame: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
Change in quality of life
Time frame: Baseline up to 12 weeks
Intent-to-treat models will be computed using repeated measures ANOVA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 34301165Dawson JK, Dorff TB, Tuzon C, Rice JC, Schroeder ET, Lane CJ, Gross ME, Dieli-Conwright CM. Effect of Periodized Resistance Training on Skeletal Muscle During Androgen Deprivation Therapy for Prostate Cancer: A Pilot Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211035442. doi: 10.1177/15347354211035442.
- Derived from this study: PubMed 29614993Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
- Derived from this study: PubMed 28698349Kiwata JL, Dorff TB, Todd Schroeder E, Salem GJ, Lane CJ, Rice JC, Gross ME, Dieli-Conwright CM. A pilot randomised controlled trial of a periodised resistance training and protein supplementation intervention in prostate cancer survivors on androgen deprivation therapy. BMJ Open. 2017 Jul 10;7(7):e016910. doi: 10.1136/bmjopen-2017-016910.
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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.
E. Todd Schroeder principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, nutritional supplementation and quality-of-life assessment in people with Prostate Cancer, run by University of Southern California at 1 site in United States.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 19 Jun 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the resistance training program with at least 80% of the sessions attended (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909440, which also lists 3 linked publications.
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 19 Jun 2019.