Time-Restricted Eating for Prostate Cancer Survivorship
(ADRIAN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Maryland, Baltimore
Must be taking: Hormone therapy
Disqualifiers: Chemotherapy, Radiation, Underweight, Surgery, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Frailty is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withstand stress on the physiological scale, or a reduced physiological reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will improve the body's ability to predict energy supply and demand, and therefore enable the body to allocate more resources to anabolic processes and promote resilience to cancer treatment, thereby preventing the progression of frailty. A total of 30 individuals over 55 years old undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a novel set of five physiological responsiveness measures will be used to assess physiological responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait speed. These data will allow assessment of 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and physiological responsiveness.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have any contraindications to the nutrition intervention due to medication requirements, you may not be eligible to participate.
What data supports the effectiveness of the treatment Time-restricted eating for prostate cancer survivorship?
Research on mice suggests that intermittent fasting, a form of time-restricted eating, may help manage prostate cancer by potentially prolonging survival, although results are not definitive. Additionally, combining fasting with other therapies has shown promise in improving treatment outcomes for other types of cancer.
12345Is time-restricted eating safe for humans?
Research on time-restricted eating (TRE) and similar fasting methods in humans is limited, but studies in animals suggest these methods are generally safe. In humans, TRE has been used by athletes without negative effects on performance, indicating it may be safe for healthy individuals.
16789How is time-restricted eating different from other treatments for prostate cancer?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours of food intake each day, rather than reducing the amount of food or using medication. This approach may be easier for some people to follow compared to strict calorie restriction and could potentially influence cancer growth by affecting hormone levels like insulin and IGF-1, which are linked to cancer progression.
123610Eligibility Criteria
This trial is for individuals over 55 with prostate cancer undergoing ADT therapy who can follow the study procedures and speak/read English. It's not for those who already eat within a 10-hour window, have upcoming surgery, contraindications to diet changes (like type 1 diabetes), are on artificial nutrition, underweight, or have had significant weight loss recently.Inclusion Criteria
Speak and/or read English
Be able and willing to adhere to the study procedures
I have been diagnosed with prostate cancer.
+2 more
Exclusion Criteria
I have unintentionally lost more than 10 pounds in the past year.
Already eat all their food in a window that is 10 h or shorter on most (6/7) days of the week
Be underweight (≤18.5 kg/m2)
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to a 12-week time-restricted eating (TRE) intervention or a time-unrestricted nutrition control intervention
12 weeks
Regular meetings with a nutritionist
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of frailty and physiological responsiveness
4 weeks
Participant Groups
The study tests if time-restricted eating can help older adults better handle stress from frailty and prostate cancer treatment. Participants will either follow a strict eating schedule or their usual habits for 12 weeks while researchers measure changes in frailty and physiological responses like blood pressure and glucose tolerance.
2Treatment groups
Experimental Treatment
Active Control
Group I: Time-restricted eatingExperimental Treatment2 Interventions
Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times).
Group II: Unrestricted eatingActive Control1 Intervention
Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will try to follow recommendations will no suggestion for meal timing.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. [2010]Caloric restriction (CR) delays cancer growth in animals, though translation to humans is difficult. We hypothesized intermittent fasting (i.e., intermittent extreme CR), may be better tolerated and prolong survival of prostate cancer (CaP) bearing mice.
Effect of intermittent fasting on prostate cancer tumor growth in a mouse model. [2010]Caloric restriction (CR) has been shown to have anti-cancer properties. However, CR may be difficult to apply in humans secondary to compliance and potentially deleterious effects. An alternative is intermittent CR, or in the extreme case intermittent fasting (IF). In a previous small pilot study, we found 2 days per week of IF with ad libitum feeding on the other days resulted in trends toward prolonged survival of mice bearing prostate cancer xenografts. We sought to confirm these findings in a larger study. A total of 100 (7- to 8-week-old) male severe combined immunodeficiency mice were injected subcutaneously with 1 × 10(5) LAPC-4 prostate cancer cells. Mice were randomized to either ad libitum Western Diet (44% carbohydrates, 40% fat and 16% protein) or ad libitum Western Diet with twice-weekly 24 h fasts (IF). Tumor volumes and mouse bodyweights were measured twice weekly. Mice were killed when tumor volumes reached 1000 mm(3). Serum and tumor were collected for analysis of the insulin/insulin-like growth factor 1 (IGF-1) hormonal axis. Overall, there was no difference in mouse survival (P=0.37) or tumor volumes (P ≥ 0.10) between groups. Mouse body weights were similar between arms (P=0.84). IF mice had significantly higher serum IGF-1 levels and IGF-1/IGFBP-3 ratios at killing (P
The effect of carbohydrate restriction on prostate cancer tumor growth in a castrate mouse xenograft model. [2021]No- and low-carbohydrate diets delay tumor growth compared to western diet (WD) in prostate cancer (PCa) xenograft studies. The effect of these diets in concert with androgen deprivation is unknown.
Fasting May Complement Endocrine Therapy. [2021]Preliminary findings from a recent study suggest that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy for hormone receptor-positive breast cancer may improve treatment efficacy and reduce side effects.
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.
Dose effects of modified alternate-day fasting regimens on in vivo cell proliferation and plasma insulin-like growth factor-1 in mice. [2015]Reduced cell proliferation is associated with lower cancer risk. Alternate-day fasting (ADF), defined as alternating 24-h periods of ad libitum feeding and fasting, decreases cell proliferation. The effect of modified regimens of ADF on cell proliferation, however, has not been examined. This study measured the effects of modified ADF regimens on prostate and splenic T-cell proliferation and circulating insulin-like growth factor-1 (IGF-1) levels in mice. In a 4-wk study, 24 male C57BL/6J mice were randomized to one of four interventions: 1) ADF-25% [25% calorie restriction (CR) on fast day], 2) ADF-50% (50% CR on fast day), 3) ADF-100% (100% CR on fast day), and 4) control. Body weight of the ADF-100% group was less (P
Time-restricted feeding plus resistance training in active females: a randomized trial. [2023]A very limited amount of research has examined intermittent fasting (IF) programs, such as time-restricted feeding (TRF), in active populations.
Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. [2021]Time restricted Feeding (TRF) is a dietary pattern utilized by endurance athletes, but there is insufficient data regarding its effects on performance and metabolism in this population. The purpose of this investigation was to examine the effects of a 16/8 TRF dietary pattern on exercise performance in trained male endurance runners.
Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]Cell proliferation rates represent a central element in the promotional phase of carcinogenesis. Modified alternate-day fasting (ADF), i.e., a partial 24-h fast alternated with 24-h ad libitum feeding, reduces global cell proliferation rates on a low-fat (LF) diet. Because the majority of Americans consume a diet that is high in fat, testing the antiproliferative ability of ADF on a high-fat (HF) diet is important in terms of diet tolerability in humans. Accordingly, we examined the effects of 85% restriction on the fast day (ADF-85%) with an LF or HF background diet on proliferation rates of various tissues.
Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. [2021]Assess the impact of the antifermentative diet on the dietary intake and body composition of elderly prostate cancer patients in radiotherapy.