TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group I (diet, physical activity)
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.
干预措施: Dietary Intervention (Other)
Group I (diet, physical activity)
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.
干预措施: Exercise Intervention (Other)
Group I (diet, physical activity)
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.
干预措施: Quality-of-Life Assessment (Other)
Group I (diet, physical activity)
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.
干预措施: Questionnaire Administration (Other)
Group II (standard lifestyle recommendations)
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.
干预措施: Best Practice (Other)
Group II (standard lifestyle recommendations)
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.
干预措施: Quality-of-Life Assessment (Other)
Group II (standard lifestyle recommendations)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
时间窗: 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
时间窗: 0 months, 6 months
Change in body weight from baseline.
Effects of the Intervention on ADT-induced Changes in Waist Circumference
时间窗: 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
时间窗: 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
时间窗: 0 months, 6 months
Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
次要结局
未报告次要终点
研究者
Marian Neuhouser
Professor
Fred Hutchinson Cancer Center