Localized Prostate Carcinoma, Prostate Adenocarcinoma
Conditions
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.
Interventions
OTHERBest Practice
Receive standard lifestyle recommendations
OTHERDietary Intervention
Receive dietary instructions
OTHERExercise Intervention
Complete aerobic and strength/resistance exercises
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 0 months, 6 months | 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. |
| Effects of the Intervention on ADT-induced Changes in Body Weight | 0 months, 6 months | Change in body weight from baseline. |
| Effects of the Intervention on ADT-induced Changes in Waist Circumference | 0 months, 6 months | Change in waist circumference from baseline. Waist circumference was measured at 1 above umbilicus. |
| Effects of the Intervention on ADT-induced Changes in Lean Mass | 0 months, 6 months | Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). |
| Effects of the Intervention on ADT-induced Changes in Fat Mass | 0 months, 6 months | Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 11 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
| Overall Study | Withdrawal due to complications with standard of care treatment | 2 | 0 |
Baseline characteristics
| Characteristic | Group I (Diet, Physical Activity) | Group II (Standard Lifestyle Recommendations) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 11 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Continuous | 71.0 years STANDARD_DEVIATION 5.7 | 73.6 years STANDARD_DEVIATION 4.5 | 72.43 years STANDARD_DEVIATION 5.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 11 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 5 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Effects of the Intervention on ADT-induced Changes in Body Weight
Change in body weight from baseline.
Time frame: 0 months, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Diet, Physical Activity) | Effects of the Intervention on ADT-induced Changes in Body Weight | -1.24 kg | Standard Deviation 2.6 |
| Group II (Standard Lifestyle Recommendations) | Effects of the Intervention on ADT-induced Changes in Body Weight | 1.01 kg | Standard Deviation 1.9 |
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).
Time frame: 0 months, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Diet, Physical Activity) | Effects of the Intervention on ADT-induced Changes in Fat Mass | 1307 g | Standard Deviation 2984 |
| Group II (Standard Lifestyle Recommendations) | Effects of the Intervention on ADT-induced Changes in Fat Mass | 2491 g | Standard Deviation 1189 |
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.
Time frame: 0 months, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Diet, Physical Activity) | Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 4.5 percentage change | Standard Deviation 52.1 |
| Group II (Standard Lifestyle Recommendations) | Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 42.7 percentage change | Standard Deviation 28.1 |
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).
Time frame: 0 months, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Diet, Physical Activity) | Effects of the Intervention on ADT-induced Changes in Lean Mass | -998 g | Standard Deviation 1604 |
| Group II (Standard Lifestyle Recommendations) | Effects of the Intervention on ADT-induced Changes in Lean Mass | -1129 g | Standard Deviation 1423 |
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.
Time frame: 0 months, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Diet, Physical Activity) | Effects of the Intervention on ADT-induced Changes in Waist Circumference | 3.4 cm | Standard Deviation 1.5 |
| Group II (Standard Lifestyle Recommendations) | Effects of the Intervention on ADT-induced Changes in Waist Circumference | 1.8 cm | Standard Deviation 7.3 |