Time-Restricted Eating for Prostate Cancer Survivorship

(ADRIAN Trial)

Overseen By Amber Kleckner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Must be taking: Hormone therapy

Disqualifiers: Chemotherapy, Radiation, Underweight, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (also known as intermittent fasting or the 16:8 eating pattern) can improve frailty in people with prostate cancer receiving hormone therapy. Frailty reduces the ability to handle stress and maintain independence. The idea is that eating within a specific 10-hour window might enhance the body's resilience to cancer treatments. Participants will either follow this time-restricted eating plan or continue with regular eating patterns to assess the impact on their overall health. Individuals with prostate cancer undergoing hormone therapy, such as androgen deprivation therapy, might be suitable for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) is generally safe for people with cancer. Early results suggest that TRE is feasible and acceptable for participants, with indications that it might enhance quality of life. Although studies in humans remain limited, TRE has been tested in various contexts without major safety concerns.

Additionally, researchers are studying TRE for its potential to reduce side effects from cancer treatments like radiation and chemoradiation, which contributes to its safety profile. It's important to note that this trial is in the early stages and partly aims to assess safety. So far, evidence suggests TRE is well-tolerated, but ongoing studies will provide more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating for prostate cancer survivorship because it focuses on when you eat, rather than what you eat, which is a fresh approach compared to existing treatments like hormonal therapy and chemotherapy. This method allows participants to choose a 10-hour window for all their meals, potentially enhancing metabolism and improving overall health without additional medications. Such a non-invasive strategy could offer a complementary way to support prostate cancer patients' well-being alongside traditional therapies.

What evidence suggests that time-restricted eating could be an effective treatment for frailty in prostate cancer survivors?

Research has shown that time-restricted eating (TRE), which participants in this trial may follow, might benefit people with prostate cancer. Early findings suggest that TRE is feasible and can enhance the quality of life for cancer patients. One study found that TRE might help control cancer by lowering certain protein levels, potentially slowing tumor growth. Another study with mice that had prostate cancer indicated that intermittent fasting might improve survival rates, although the results were not statistically significant. Overall, TRE could offer a new way to support cancer treatment and might help prevent frailty in older adults. ^{1 3 4 5 6}

Who Is on the Research Team?

Amber Kleckner, PhD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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)

I have unintentionally lost more than 10 pounds in the past year.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview

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.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 2 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 eating Active Control 1 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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Preliminary findings indicate that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy may enhance the effectiveness of treatment for hormone receptor-positive breast cancer.

This combination approach could also help in reducing side effects associated with the endocrine therapy, suggesting a potential strategy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [2021]

In a study involving 100 mice with prostate cancer, intermittent fasting (IF) did not improve survival rates or delay tumor growth compared to a regular diet, indicating that this approach may not be effective for cancer treatment in this model.

Despite the lack of survival benefits, mice undergoing IF showed significantly higher levels of IGF-1, suggesting that metabolic changes during fasting may counteract potential anti-cancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting on prostate cancer tumor growth in a mouse model. Thomas, JA., Antonelli, JA., Lloyd, JC., et al.[2010]

In a study involving 160 male SCID mice with prostate cancer, a 20% carbohydrate diet significantly slowed tumor growth compared to a western diet, suggesting dietary modifications may impact cancer progression.

While survival rates did not significantly differ among the various carbohydrate-restricted diets, there was a non-significant trend indicating improved survival for those on carbohydrate-restricted diets compared to the western diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of carbohydrate restriction on prostate cancer tumor growth in a castrate mouse xenograft model. Caso, J., Masko, EM., Ii, JA., et al.[2021]

In a study of 45 elderly men undergoing radiotherapy for prostate cancer, the antifermentative diet led to a significant decrease in energy and nutrient intake, including essential vitamins and minerals, during treatment.

Body composition was adversely affected by the diet, with participants experiencing reductions in body weight, arm circumference, and other measurements by the end of radiotherapy, indicating potential negative impacts on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. de Oliveira Pedron, ÉL., de Cássia de Aquino, R., Borin da Silva, C.[2021]

A systematic review of 20 randomized controlled trials found that diet interventions, either alone or combined with exercise, can lead to significant weight loss in men treated for prostate cancer, with weight loss ranging from 0.8 kg to 6.1 kg.

Exercise alone did not result in weight loss, as most trials focused on improving fitness and quality of life rather than reducing body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. Mohamad, H., McNeill, G., Haseen, F., et al.[2022]

In a pilot study involving 105 male SCID mice with prostate cancer, intermittent fasting regimens showed non-significant trends toward improved survival compared to a control group, suggesting potential benefits of fasting in cancer management.

Mice on certain fasting diets had significantly lower body weights and IGF-1 levels, indicating that these dietary interventions may influence cancer growth mechanisms, although no significant survival differences were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. Buschemeyer, WC., Klink, JC., Mavropoulos, JC., et al.[2010]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

In a 4-week study with 24 male mice, the modified alternate-day fasting (ADF-100%) regimen significantly reduced prostate cell proliferation by 49% and T-cell proliferation by 30%, indicating a potential decrease in cancer risk.

The ADF-100% group also showed a 40% reduction in circulating insulin-like growth factor-1 (IGF-1) levels, which is associated with lower cancer risk, while other modified ADF regimens (ADF-25% and ADF-50%) did not produce similar effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose effects of modified alternate-day fasting regimens on in vivo cell proliferation and plasma insulin-like growth factor-1 in mice. Varady, KA., Roohk, DJ., Hellerstein, MK.[2015]

Intermittent fasting through time-restricted feeding (TRF) did not hinder muscle growth or performance in resistance-trained females, showing that similar gains can be achieved regardless of feeding schedule, as long as energy and protein intake are maintained.

Participants on TRF experienced a significant reduction in fat mass compared to those on a control diet, suggesting that TRF may be beneficial for fat loss without compromising muscle adaptations during resistance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding plus resistance training in active females: a randomized trial. Tinsley, GM., Moore, ML., Graybeal, AJ., et al.[2023]

A 4-week study on trained male endurance runners showed that a 16/8 time-restricted feeding (TRF) pattern led to a significant decrease in fat mass without affecting fat-free mass or running performance.

While the TRF group experienced lower carbon dioxide production and blood lactate levels during exercise, their 10 km time trial performance remained unchanged compared to those on a normal diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Weeks of 16/8 Time Restrictive Feeding in Endurance Trained Male Runners Decreases Fat Mass, without Affecting Exercise Performance. Tovar, AP., Richardson, CE., Keim, NL., et al.[2021]

Citations

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Time-restricted eating is a type of intermittent fasting. Food can be consumed as desired during the eating period but not during the remainder of the day.

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This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to ...

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academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer

Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

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withpower.com

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Time-Restricted Eating for Prostate Cancer Survivorship

In a pilot study involving 105 male SCID mice with prostate cancer, intermittent fasting regimens showed non-significant trends toward improved survival ...

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Intermittent fasting enhances efficacy of prostate cancer ...

The results demonstrate that alternate-day fasting reduced amino acid levels and global protein synthesis within prostate cancer tumors, making ...

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NCT05722288 | Time-Restricted Eating Versus Nutritional ...

This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...