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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02762 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P50CA097186 | U.S. NIH Grant/Contract | View source | |
| 10669 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.
OUTLINE:
Patients are randomized to 1 of 2 groups.
GROUP I (DIET AND PHYSICAL ACTIVITY): Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instructions on a modified DASH diet. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
GROUP II (CONTROL): Patients attend a single in-person or virtual session with a registered dietitian to receive standard lifestyle recommendations based on the United States (US) dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (diet, physical activity) | Experimental | Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on healthy dietary pattern. Patients also attend 2 one-on-one sessions with an exercise physiologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. |
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| Group II (standard lifestyle recommendations) | Active Comparator | Patients attend a single session with a dietitian to review healthy lifestyle recommendations, including US dietary guidelines and 30 minutes of physical activity 5 days/week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard lifestyle recommendations |
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| Measure | Description | Time Frame |
|---|---|---|
| Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405. | 0 months, 6 months |
| Effects of the Intervention on ADT-induced Changes in Body Weight | Change in body weight from baseline. | 0 months, 6 months |
| Effects of the Intervention on ADT-induced Changes in Waist Circumference | Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus. | 0 months, 6 months |
| Effects of the Intervention on ADT-induced Changes in Lean Mass | Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). | 0 months, 6 months |
| Effects of the Intervention on ADT-induced Changes in Fat Mass | Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). | 0 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marian L. Neuhouser | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Diet, Physical Activity) | Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on following a healthy diet pattern. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. Dietary Intervention: Receive dietary instructions Exercise Intervention: Complete aerobic and strength/resistance exercises Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2024 |
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| Dietary Intervention | Other | Receive dietary instructions |
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| Exercise Intervention | Other | Complete aerobic and strength/resistance exercises |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| FG001 | Group II (Standard Lifestyle Recommendations) | Patients receive standard lifestyle recommendations and attend a single individual session with a dietitian to review the US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week. |
| COMPLETED |
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| NOT COMPLETED |
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Participants randomized to the intervention or control arms
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Diet, Physical Activity) | Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. Dietary Intervention: Receive dietary instructions Exercise Intervention: Complete aerobic and strength/resistance exercises Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | Group II (Standard Lifestyle Recommendations) | Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss. Best Practice: Receive standard lifestyle recommendations Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405. | Posted | Mean | Standard Deviation | percentage change | 0 months, 6 months |
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| Primary | Effects of the Intervention on ADT-induced Changes in Body Weight | Change in body weight from baseline. | Posted | Mean | Standard Deviation | kg | 0 months, 6 months |
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| Primary | Effects of the Intervention on ADT-induced Changes in Waist Circumference | Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus. | Posted | Mean | Standard Deviation | cm | 0 months, 6 months |
| |||||||||||||||||||||||||||||||
| Primary | Effects of the Intervention on ADT-induced Changes in Lean Mass | Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). | Posted | Mean | Standard Deviation | g | 0 months, 6 months |
| |||||||||||||||||||||||||||||||
| Primary | Effects of the Intervention on ADT-induced Changes in Fat Mass | Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). | Posted | Mean | Standard Deviation | g | 0 months, 6 months |
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up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Diet, Physical Activity) | Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. Dietary Intervention: Receive dietary instructions Exercise Intervention: Complete aerobic and strength/resistance exercises Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 9 | 0 | 9 | 5 | 9 |
| EG001 | Group II (Standard Lifestyle Recommendations) | Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss. Best Practice: Receive standard lifestyle recommendations Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 11 | 0 | 11 | 0 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Hip and back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| elevated liver function tests | Hepatobiliary disorders | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Presyncope | Cardiac disorders | Non-systematic Assessment |
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This is a pilot feasibility study with a sample size of 20 participants. Results should be interpreted accordingly.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian L. Neuhouser, PhD | Fred Hutch Cancer Center | 206-667-4797 | mneuhous@fredhutch.org |
| Dec 8, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2022 | Jan 23, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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