A Multidisciplinary Team-Based Approach to Mitigate the Impact of Androgen Deprivation Therapy in Prostate Cancer: A Randomized Phase 2
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)
研究概览
简要总结
This pilot partially-randomized phase II trial studies how well Supportive Therapy in Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side effects in patients with prostate cancer. Individualized counseling regarding exercise and dietary habits may help improve patient understanding, satisfaction, and overall lessen adverse impact on quality of life caused by androgen deprivation.
详细描述
PRIMARY OBJECTIVES:
I. To compare the mean percent change from baseline to 12 months in percentage body fat mass among men with prostate cancer receiving androgen deprivation therapy randomized to participate in the ?STAND? clinic versus (vs.) usual standard of care. (Randomized Cohort) II. To determine the feasibility of completing multi-disciplinary STAND clinic visits within context of concurrent chemohormonal therapy for prostate cancer. (Non-randomized Pilot Cohort)
SECONDARY OBJECTIVES:
I. To compare the mean percent change from baseline to 12 months and patterns of change over time during participation in the STAND clinic vs. usual standard of care with respect to: metabolic impact on diabetes and cardiovascular risk factors, bone health, and quality of life/psychosocial impact.
II. Among men randomized to receive usual standard of care that cross-over to participate in the STAND clinic after month 12 of the study: to measure the mean change from baseline at start of participation in the STAND clinic after 12 months of participation in: metabolic parameters including percentage body fat, fasting insulin/glucose, homeostatic model assessment insulin resistance (HOMA-IR), body weight/body mass index, waist circumference; bone health; quality of life; and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic confirmation of adenocarcinoma of the prostate
- •Receiving or planning to receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
- •Expected duration of ADT at least 12 months from date of study consent
- •Concurrent antiandrogen therapy allowed but not required
- •First dose of LHRH agonist or antagonist no more than 6 months prior to date of study content
- •Prior/concurrent radiation allowed
- •Other investigational agents in addition to LHRH agonist/antagonist are allowed (e.g. novel anti-androgens, androgen synthesis inhibitors)
- •Prior androgen deprivation therapy allowed, provided there is documented evidence of testosterone recovery to > 150 ng/dL and greater than 12 months duration between last ?effective? date of ADT and date of study consent
- •Randomized cohort only:
- •No prior chemotherapy within 12 months of start date of study
- •No planned chemotherapy at least 12 months from study entry
- •Non-randomized pilot cohort:
- •Concurrent chemotherapy (initiated within 3 months of study entry) or planned chemotherapy within 3 months of study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 ? 2
- •Ability to sign written informed consent
- •Willing to attend monthly clinic visits at University of California, San Francisco (UCSF)
排除标准
- •Physically unable or unwilling to participate in recommended exercise programs or travel to UCSF on a monthly basis
- •Presence of permanent pacemaker or implantable medical device
- •Artificial joint prostheses and venous filters are allowed
研究组 & 干预措施
Arm I (standard of care)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.
干预措施: Goserelin Acetate (Drug)
Arm I (standard of care)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (standard of care)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.
干预措施: Leuprolide Acetate (Drug)
Arm I (standard of care)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.
干预措施: Quality-of-Life Assessment (Other)
Arm I (standard of care)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.
干预措施: Triptorelin Pamoate (Drug)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Behavioral Dietary Intervention (Behavioral)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Counseling (Other)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Educational Intervention (Other)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Exercise Intervention (Behavioral)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Goserelin Acetate (Drug)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Leuprolide Acetate (Drug)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Quality-of-Life Assessment (Other)
Arm II (STAND clinic)
Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.
干预措施: Triptorelin Pamoate (Drug)
结局指标
主要结局
Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)
时间窗: Up to 12 months
The absolute change from baseline in percentage body fat after 12 months of study participation for participants in the randomized cohort was measured using a bioelectrical impedance analyzer and between group comparisons were performed using the Wilcoxon-rank-sum test.
Percentage of Participants in the Non-randomized, Pilot, Cohort Who Completed Clinic Visits
时间窗: Up to 12 months
The percentage of participants in the pilot, non-randomized cohort who completed clinic visits for Supportive Therapy in Androgen Deprivation (STAND) will be reported to assess feasibility.
次要结局
- Absolute Change in Blood Pressure (Randomized Cohort)(Up to 12 months)
- Absolute Change in Body Weight (Randomized Cohort)(Up to 12 months)
- Absolute Change in Percentage of Body Fat (Randomized Cohort)(Up to 12 months)
- Absolute Change in Waist Circumference (Randomized Cohort)(Up to 12 months)
- Absolute Change in Hemoglobin A1c (Randomized Cohort)(Up to 12 months)
- Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort)(Up to 12 months)
- Absolute Change in Average Moderate to Vigorous Physical Activity (MVPA) as Measured by an Ambulatory Accelerometer Assessment (Randomized Cohort)(Up to 12 months)
- Absolute Change in Hot Flash Related Daily Interference Scale Score (HFRDIS) (Randomized Cohort)(Up to 12 months)
- Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort)(Up to 12 months)
- Absolute Change in Insulin Resistance Score (Randomized Cohort)(Up to 12 months)
- Absolute Change in Fasting Lipids (Randomized Cohort)(Up to 12 months)
- Absolute Change in Bone Density T-score (Randomized Cohort)(Up to 12 months)
- Absolute Change in Patient Health Questionnaire-9 (PHQ-9) Scores (Randomized Cohort)(Up to 12 months)
- Absolute Change in Attention Function Index (AFI) Scores (Randomized Cohort)(Up to 12 months)
- Absolute Change in International Prostate Symptom Score (IPSS) (Randomized Cohort)(Up to 12 months)
- Absolute Change in Serum 25-(OH) Vitamin D (Randomized Cohort)(Up to 12 months)
- Absolute Change in Lee Fatigue Scale Scores (Randomized Cohort)(Up to 12 months)
- Absolute Change in the 12-item Short Form Survey (SF-12) Assessment Item Scores for Patients in the Randomized Cohort(Up to 12 months)
- Absolute Change in Last Question on International Prostate Symptom Score (IPSS) (Randomized Cohort)(Up to 12 months)