Intermittent Fasting for Prostate Cancer

Overseen By Kyle Pasquariello

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must be taking: Androgen deprivation

Disqualifiers: Other malignancy, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intermittent Fasting for Prostate Cancer?

Research in mice suggests that intermittent fasting may help reduce cancer cell growth and improve survival, although results are mixed and more studies are needed to confirm these effects in humans. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Alternate day fasting (ADF), a type of intermittent fasting, has been studied for weight loss and showed no significant adverse events or increase in eating disorder symptoms, suggesting it is generally safe for humans. ^{1 2 3 6 7}

How does intermittent fasting differ from other treatments for prostate cancer?

Intermittent fasting is unique because it involves cycles of eating and fasting, which may be easier to follow than continuous calorie restriction and could potentially affect cancer growth by altering hormone levels like insulin and IGF-1, unlike traditional treatments that often involve medication or surgery. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for prostate cancer patients who are currently undergoing androgen deprivation therapy. It's designed to see if they can stick to a schedule of intermittent fasting, with the option to follow a plant-enriched diet.

Inclusion Criteria

My organ functions are within normal ranges as per recent tests.

I have prostate cancer that can be measured and I am eligible for hormone therapy.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I cannot or will not sign the consent form for this trial.

I have not been in a clinical trial for a new treatment or device in the last 4 weeks.

I need assistance with my daily activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intermittent fasting with optional plant-enriched diet while receiving androgen deprivation therapy

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intermittent Fasting

Trial Overview The study is testing whether intermittent fasting (with or without a plant-enriched diet) is practical for these patients. The focus is on how well participants can enroll, stay in the study, and follow the dietary guidelines.

Participant Groups

Group I: Intermittent Fasting Experimental Treatment 1 Intervention

Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Findings from Research

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]

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 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]

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]

Fasting may enhance cancer treatment effectiveness and reduce side effects by creating conditions that hinder cancer cell survival and growth, as suggested by emerging evidence.

The review emphasizes the need for an integrated understanding of how fasting interacts with cancer therapies, recommending the combination of prolonged periodic fasting with standard treatments to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. Tiwari, S., Sapkota, N., Han, Z.[2022]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

A study is being conducted to explore the effects of alternate day fasting (ADF) on healthy non-obese individuals, involving 90 participants, with some having followed ADF for at least 6 months and others starting ADF for 4 weeks.

The research aims to assess various health parameters, including metabolic and cardiovascular effects, using advanced techniques like echocardiography and glucose monitoring, to better understand the physiological impacts of ADF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Tripolt, NJ., Stekovic, S., Aberer, F., et al.[2022]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting on prostate cancer tumor growth in a mouse model. [2010]

3. United States 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of carbohydrate restriction on prostate cancer tumor growth in a castrate mouse xenograft model. [2021]