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Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study

Primary Purpose

Localized Prostate Carcinoma, Prostate Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Dietary Intervention
Exercise Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Localized Prostate Carcinoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40-70 years
  • Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
  • Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
  • Physically able to undertake an exercise program

Exclusion Criteria:

  • Advanced, metastatic disease
  • Planning to join a commercial/structured diet change or fitness program
  • Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
  • Physician confirmed cognitive impairment or alcohol/narcotic abuse

Sites / Locations

  • Veterans Affairs Puget Sound Health Care System
  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (diet, physical activity)

Group II (standard lifestyle recommendations)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effects of the intervention on androgen deprivation therapy (ADT)-induced changes in Homeostatic Model Assessment for Insulin Resistance
Homeostatic model assessment of insulin resistance (HOMA-IR) will be computed from glucose and insulin concentrations. Compare change in HOMA-IR levels relative to baseline between intervention and control participants. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in body weight
Weight will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in waist circumference
Waist (1" above umbilicus) circumferences will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in lean mass
Lean mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.
Effects of the intervention on ADT-induced changes in fat mass
Fat mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2021
Last Updated
September 27, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04870515
Brief Title
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
Official Title
TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Prostate Carcinoma, Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (diet, physical activity)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (standard lifestyle recommendations)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard lifestyle recommendations
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Receive dietary instructions
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete aerobic and strength/resistance exercises
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Effects of the intervention on androgen deprivation therapy (ADT)-induced changes in Homeostatic Model Assessment for Insulin Resistance
Description
Homeostatic model assessment of insulin resistance (HOMA-IR) will be computed from glucose and insulin concentrations. Compare change in HOMA-IR levels relative to baseline between intervention and control participants. Will be evaluated using linear regression models.
Time Frame
Up to 6 months
Title
Effects of the intervention on ADT-induced changes in body weight
Description
Weight will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Time Frame
Up to 6 months
Title
Effects of the intervention on ADT-induced changes in waist circumference
Description
Waist (1" above umbilicus) circumferences will be measured at baseline and 6 months. Will be evaluated using linear regression models.
Time Frame
Up to 6 months
Title
Effects of the intervention on ADT-induced changes in lean mass
Description
Lean mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.
Time Frame
Up to 6 months
Title
Effects of the intervention on ADT-induced changes in fat mass
Description
Fat mass will be measured by dual-energy x-ray absorptiometry at baseline and 6 months. Will be evaluated using linear regression models.
Time Frame
Up to 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 40 years Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional) Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed Physically able to undertake an exercise program Exclusion Criteria: Advanced, metastatic disease Planning to join a commercial/structured diet change or fitness program Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months) Physician confirmed cognitive impairment or alcohol/narcotic abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marian L. Neuhouser
Phone
206-667-4797
Email
mneuhous@fredhutch.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan L. Wright
Phone
206-579-8922
Email
jlwright@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian L. Neuhouser
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Withdrawn
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian L. Neuhouser
Phone
206-667-4797
Email
mneuhous@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Jonathan L. Wright
Phone
206-579-8922
Email
jlwright@uw.edu
First Name & Middle Initial & Last Name & Degree
Marian L. Neuhouser

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study

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