Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00341 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 72118 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.
PRIMARY OBJECTIVES:
I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.
II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.
III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.
EXPLORATORY OBJECTIVES:
I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.
II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.
OUTLINE:
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (diet, exercise, education) | Experimental | Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Receive diet plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition | Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat. | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscle strength | Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB). | Baseline up to 6 months |
| Changes in functional capacity muscle strength |
| Measure | Description | Time Frame |
|---|---|---|
| Serum prostate specific antigen (PSA) and androgen levels | Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels. | Up to 6 months |
| Adherence to nutrition and exercise advice |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellis Levine, MD | Contact | 716-845-3159 | Ellis.Levine@Roswellpark.org |
| Name | Affiliation | Role |
|---|---|---|
| Ellis Levine, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Educational Intervention | Other | Attend educational meeting |
|
|
| Exercise Intervention | Behavioral | Complete exercise program |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Survey Administration | Other | Ancillary studies |
|
Improvement of muscle strenght |
| Baseline up to 6 months |
| Change in body composition | All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition | Baseline up to 6 months |
| myokines concentration | Will be assessed by serum biomarker levels. | Baseline up to 6 months |
| cytokines concentration | Will be assessed by serum biomarker levels. | Baseline up to 6 months |
| Health related quality of life Short Form | Will be used to assess quality of life . The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, Lower scores = more disability, higher scores = less disability | Up to 6 months |
| Changes in dietary intake | Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey. | Baseline up to 6 months |
| Changes in physical activity | Will be assessed by Godin Leisure Time survey and Fitbit activity report. Will be summarized by time point using the observed sample size, mean, and standard deviation. Will be evaluated using a two-sided permutation paired t-test. Additionally, the mean change in each outcome will be estimated using a 95% confidence interval. As exploratory analyses, the association between the change in each outcome and demographic/clinical factors may be evaluated using general linear models. The change in outcome will be modeled as a function of baseline levels and each demographic/clinical factor in a one-at-a-time manner. | Baseline up to 6 months |
| Change in fatigue | Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey. | Baseline up to 6 months |
| Change in Respiratory Muscle Strength | Mouth pressure device | Baseline up to 6 months |
Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.
| Up to 6 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
Not provided
Not provided