Nutrition and Exercise Advice for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Roswell Park Cancer Institute
Must be taking: Androgen deprivation therapy
Disqualifiers: COPD, Heart disease, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Nutrition and Exercise Advice for Prostate Cancer?
Research shows that diet and exercise interventions can help men with prostate cancer lose weight and improve their quality of life. A systematic review found that diet, alone or combined with exercise, led to significant weight loss, which is important for better health outcomes.
12345Is the Nutrition and Exercise Advice for Prostate Cancer treatment safe for humans?
The studies show that nutrition and exercise interventions for prostate cancer patients, including those undergoing androgen deprivation therapy, are generally safe and well-tolerated. Participants in these studies did not experience serious adverse events, indicating that these interventions are safe for humans.
35678How does the Nutrition and Exercise Advice treatment for prostate cancer differ from other treatments?
This treatment is unique because it combines dietary changes, exercise, and education to help manage prostate cancer, focusing on improving quality of life and potentially reducing cancer progression by maintaining a healthy weight. Unlike traditional treatments that may focus solely on medication or surgery, this approach emphasizes lifestyle changes to support overall health and well-being.
13459Eligibility Criteria
This trial is for prostate cancer survivors who are overweight or obese and have been on androgen deprivation therapy for less than 5 years. They must be able to walk, have normal liver function, not be receiving other cancer treatments like chemo, and can't have severe heart or lung conditions.Inclusion Criteria
Creatinine < 1.5 x upper limit of normal (ULN), AST or ALT <2 x ULN within 6 months prior to enrollment
You have a high body mass index (BMI), indicating that you are overweight or obese.
I have been on hormone therapy for less than 5 years.
+7 more
Exclusion Criteria
You have certain orthopedic, musculoskeletal or psychological conditions that may limit your participation (decided by the doctor).
Your doctor thinks that you are too weak or frail to participate in the study.
Unwilling or unable to follow protocol requirements
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive an individualized diet plan and complete a home-based exercise program for 6 months, including aerobic and resistance exercises, and attend monthly educational meetings.
6 months
Monthly educational meetings
Follow-up
Participants are monitored for changes in body composition, muscle strength, and other health metrics after the intervention.
4-8 weeks
Participant Groups
The study tests if personalized nutrition advice and exercise programs can reduce obesity-related weakness in men treated with hormone therapy for prostate cancer. It also looks at changes in blood levels of muscle-related proteins (myokines).
1Treatment groups
Experimental Treatment
Group I: Supportive care (diet, exercise, education)Experimental Treatment5 Interventions
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who Is Running the Clinical Trial?
Roswell Park Cancer InstituteLead Sponsor
References
Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. [2021]Diet and exercise may be associated with quality of life and survival in men with prostate cancer.
Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study. [2023]Healthy diet and exercise can improve quality of life and prognosis among men with prostate cancer. Understanding the perceived barriers to lifestyle change and patient preferences in a diverse cohort of men with prostate cancer is necessary to inform mobile health (mHealth) lifestyle interventions and increase health equity.
Nutrition Education Seminars for Prostate Cancer-Diet and Prostate Program: Evaluation and Recommendations (DAPPER Study). [2022]Nutrition is important for prostate cancer (PCa) care as it may influence PCa progression and risk of comorbid diseases. The aim of this pilot study was to assess changes in knowledge and satisfaction in men with PCa following attendance at a nutrition education seminar. Fifty-two men with PCa attended nutrition education seminars instructed by a Registered Dietitian. Participants completed the Revised General Nutrition Knowledge Questionnaire (GNKQ-R) preseminar and 2 weeks postseminar, along with a satisfaction survey. Increased nutrition knowledge was observed through a significant (P = 0.023) improvement in mean scores of 71.6% (P < 0.005) preseminar compared with 79.3% (P < 0.005) postseminar on the GNKQ-R. Participants reported the seminar as a satisfactory method for meeting their diet information needs. Using thematic analysis 3 themes emerged: importance of diet information, desire for an integrative approach, and the value of group learning. This pilot study found that a group nutrition education seminar may be an effective and satisfactory approach to fulfilling the dietary information needs of this population. Group education may be an economically sustainable approach with potential application in other tumour sites or health conditions.
The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. [2022]Prostate cancer prognosis may therefore be improved by maintaining healthy weight through diet and physical activity. This systematic review looked at the effect of diet and exercise interventions on body weight among men treated for prostate cancer. MEDLINE, EMBASE, CINAHL, and Cochrane Library databases were searched from the earliest record to August 2013. Randomized controlled trials of diet and exercise interventions in prostate cancer patients that reported body weight or body composition changes were included. A total of 20 trials were included in the review. Because of the heterogeneity of intervention components, a narrative review was conducted. Interventions were categorized as diet (n = 6), exercise (n = 8), or a combination of both diet and exercise (n = 6). The sample size ranged from 8 to 155 and the duration from 3 wk to 4 yr. Four diet interventions and 1 combined diet and exercise intervention achieved significant weight loss with mean values ranging from 0.8 kg to 6.1 kg (median 4.5 kg). Exercise alone did not lead to weight loss, though most of these trials aimed to increase fitness and quality of life rather than decrease body weight. Diet intervention, alone or in combination with exercise, can lead to weight loss in men treated for prostate cancer.
Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). [2023]Nutrition and physical activity are associated with prostate cancer recurrence and mortality. Few randomized controlled trials (RCT) have examined the effects of long-term exercise and diet changes on prostate cancer clinical, biological, and patient-reported outcomes.
Nutrition services during prostate cancer androgen deprivation therapy. [2023]Dietary interventions are effective strategies to mitigate multiple side effects from androgen deprivation therapy (ADT) in prostate cancer, however the perception of, and access to, nutrition services is relatively unknown.
Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial). [2022]Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer.
Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). [2021]Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.
Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]To assess the use of diet and the use of exercise for prostate cancer (and/or its treatments' side effects) by long-term survivors and whether such use is associated with selected socio-demographic, clinical, health-related quality-of-life (HRQOL) and psychological factors.