Fasting-Mimicking Diet for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Stephen Freedland, MD

Age: Any Age

Sex: Male

Trial Phase: Phase 2

Sponsor: Stephen Freedland

Must be taking: ADT, Abiraterone, Apalutamide, Enzalutamide

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Cardiac, Pulmonary, Liver, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

138 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians. 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 cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have diabetes, you must be on stable doses of your medication for at least 6 months and have your doctor's consent to safely pause it during the 5-day fasting period each month.

What data supports the effectiveness of the treatment Fasting Mimicking Diet (FMD) for prostate cancer?

Research shows that a fasting-mimicking diet (FMD) improved the response to chemotherapy in breast cancer patients, suggesting it might help enhance cancer treatment effectiveness. Additionally, low-carbohydrate diets have been found to delay prostate cancer tumor growth in animal studies, which may indicate potential benefits of dietary interventions like FMD for prostate cancer. ^{1 2 3 4 5}

Is the fasting-mimicking diet generally safe for humans?

Fasting-mimicking diets (FMDs) are considered safer and less challenging than other fasting methods, and they have been tested in several clinical trials for safety when combined with cancer treatments. ^{1 2 6 7 8}

How does the fasting-mimicking diet treatment differ from other prostate cancer treatments?

The fasting-mimicking diet (FMD) is unique because it mimics the effects of fasting without requiring complete food abstinence, potentially enhancing the effectiveness of cancer treatments by targeting resistant cancer cells. Unlike traditional prostate cancer treatments, which often focus on medication or surgery, FMD is a dietary approach that may work synergistically with other therapies to improve outcomes. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for men with metastatic castrate sensitive prostate adenocarcinoma who are starting first-line treatment. They must understand English or Spanish, have phone access, and be able to follow the study's requirements. Men with a BMI under 20, significant weight loss recently, on weight loss plans or unstable diabetes medications, practicing fasting diets that affect the study, or with serious health issues like heart disease aren't eligible.

Inclusion Criteria

My prostate cancer has spread and responds to hormone therapy.

I can read and write in English or Spanish and have a phone for dietitian calls.

I am a man starting or planning to start first-line ADT for prostate cancer soon.

Exclusion Criteria

I have lost 10% or more of my weight in the past 6 months.

Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation

Allergies to any ingredients listed on the Xentigen Ingredient List

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the fasting mimicking diet or usual diet along with standard of care treatment for 6 months

6 months

Monthly visits for diet monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fasting Mimicking Diet (FMD)

Trial Overview The study compares the effects of a Fasting Mimicking Diet (FMD) versus a standard diet in patients undergoing cancer treatment. Participants will eat special L-Nutra products for 5 days each month over half a year while continuing their usual cancer care.

Participant Groups

Group I: Fasting Mimicking Diet Experimental Treatment 1 Intervention

Intermittent fasting using a fasting mimicking diet

Group II: Standard Anti-Cancer Diet Placebo Group 1 Intervention

Standard Anti-Cancer Diet

Who Is Running the Clinical Trial?

Stephen Freedland

Lead Sponsor

Trials

2

Recruited

190+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a phase II study involving 129 patients with HER2-negative breast cancer, a fasting mimicking diet (FMD) improved patients' perceptions of chemotherapy side effects and overall quality of life compared to a regular diet.

Patients adhering to the FMD reported better emotional, physical, and social functioning, along with lower levels of fatigue, nausea, and insomnia, suggesting that FMD may enhance the supportive care during neoadjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. Lugtenberg, RT., de Groot, S., Kaptein, AA., et al.[2021]

Fasting or a fasting-mimicking diet (FMD) can slow down tumor growth but does not enhance the sensitivity of colorectal cancer (CRC) cells to chemotherapy drugs like 5-fluorouracil and oxaliplatin, indicating a complex relationship between fasting and cancer treatment.

The study identified that fasting induces CRC cells to enter a slow-cycling state, which may lead to the development of drug-tolerant persister cells that contribute to cancer relapse; however, combining fasting with ferroptosis inducers could enhance tumor inhibition and target these resistant cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. Liu, X., Peng, S., Tang, G., et al.[2023]

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]

A review of 16 studies on dietary interventions for men undergoing androgen deprivation therapy (ADT) for prostate cancer found limited evidence supporting their effectiveness, with only one study showing that daily caffeinated beverages helped reduce cancer-related fatigue.

Most studies combined diet with other interventions like physical activity or medication, and there was a lack of consistent reporting on dietary intake, making it difficult to assess the feasibility and acceptability of these dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition care guidelines for men with prostate cancer undergoing androgen deprivation therapy: do we have enough evidence? Barnes, KA., Ball, LE., Galvão, DA., et al.[2020]

In a pilot study involving 18 prostate cancer patients, a low-fat diet combined with a soy supplement did not achieve the primary goal of reducing prostate-specific antigen (PSA) levels by 50%.

While the soy supplement did not lower PSA levels, it was associated with a modest increase in the time to progression of the disease and a significant rise in insulin-like growth factor (IGF-I) levels, which could be a concern for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal effect of a low-fat/high soy diet for asymptomatic, hormonally naive prostate cancer patients. Spentzos, D., Mantzoros, C., Regan, MM., et al.[2015]

Fasting mimicking diets (FMDs) are a safer and more manageable alternative to traditional fasting for cancer patients, potentially improving healthspan and reducing the risk of cancer and age-related diseases.

FMD cycles enhance the effectiveness of various cancer therapies in mice by boosting antitumor immunity and creating conditions that protect healthy cells while making cancer cells more vulnerable to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and fasting mimicking diets in cancer prevention and therapy. Blaževitš, O., Di Tano, M., Longo, VD.[2023]

In a phase Ib trial involving 101 patients with advanced cancer, cyclic fasting-mimicking diets (FMDs) were found to be safe and feasible when combined with standard cancer treatments, showing positive metabolic and immunologic changes.

Remarkably, five patients with poor prognosis solid tumors achieved complete and long-lasting tumor remissions, suggesting that cyclic FMD may enhance the effectiveness of standard anticancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. Ligorio, F., Fucà, G., Provenzano, L., et al.[2022]

A qualitative study involving 20 men with prostate cancer on androgen deprivation therapy (ADT) revealed that common side effects like weight gain and loss of muscle negatively impact their body image and masculinity, highlighting the need for effective dietary interventions.

Participants expressed a strong demand for specialized nutrition services to help manage ADT side effects, but faced barriers such as high costs and unclear referral pathways, indicating a significant gap in accessible nutrition support for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition services during prostate cancer androgen deprivation therapy. Baguley, B., Smith-Gillis, C., Porter, J., et al.[2023]

A diet rich in protective elements like tomatoes, cruciferous vegetables, and omega-3 fatty acids may help reduce the risk of prostate cancer, while high intakes of dairy, saturated fats, and grilled meats could increase risk.

Current evidence suggests that a balanced diet with a variety of plant-based foods and fish is advisable for prostate cancer prevention, although more clinical trials are needed to confirm the effects of specific nutrients and supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of diet in prostate cancer development and progression. Chan, JM., Gann, PH., Giovannucci, EL.[2005]

Vegetarian diets may lower the risk of prostate cancer, but the specific role of dietary fiber is unclear due to the antioxidant properties of plant foods.

A proposed nutritional approach, including a diet with low fat, high fiber, and 40 g of soybean protein daily, is being studied as a potential strategy for managing prostate cancer, although more rigorous large-scale studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. de la Taille, A., Katz, A., Vacherot, F., et al.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fasting-mimicking diet synergizes with ferroptosis against quiescent, chemotherapy-resistant cells. [2023]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Nutrition care guidelines for men with prostate cancer undergoing androgen deprivation therapy: do we have enough evidence? [2020]

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

Minimal effect of a low-fat/high soy diet for asymptomatic, hormonally naive prostate cancer patients. [2015]

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

Fasting and fasting mimicking diets in cancer prevention and therapy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Nutrition services during prostate cancer androgen deprivation therapy. [2023]

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

Role of diet in prostate cancer development and progression. [2005]

10. France pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. [2017]