Time-Restricted Diet for Brain Metastases

Overseen By Nicole Simone, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Intractable seizures, Glioma, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a time-restricted diet, supported by text messages, can reduce brain function decline and improve survival for individuals with breast or lung cancer that has spread to the brain. Participants will receive either interactive messages about meal timing or general healthy eating tips. The study seeks individuals with breast or lung cancer who are candidates for a specific type of precise radiation treatment and have a BMI of 25 or higher. As an unphased trial, this study offers a unique opportunity to explore innovative dietary interventions that could potentially enhance treatment outcomes.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, chemotherapy, hormone, and immune therapy are allowed to be taken at the same time as the trial.

What prior data suggests that this interactive time-restricted diet intervention is safe for patients with brain metastases?

Research shows that time-restricted eating, where eating occurs only during certain hours each day, is generally safe and easy to follow. Studies suggest it can lower the risk of heart disease, aid in weight management, and reduce some chemotherapy side effects. For example, one study found that women who fasted for less than 13 hours at night had a higher chance of breast cancer returning, indicating that longer fasting might be beneficial. Evidence also suggests that time-restricted eating can boost brain function and improve mental health. Overall, these findings indicate that trying a time-restricted diet like the txt4fasting intervention is likely safe and may offer health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the time-restricted diet intervention for brain metastases patients because it offers a novel approach that leverages the body's natural rhythms. Unlike traditional treatments like surgery or radiation, this method focuses on when patients eat, rather than solely on what they eat, potentially enhancing the effectiveness of other therapies like stereotactic radiosurgery (SRS). Additionally, the interactive txt4fasting platform provides real-time support and motivation through positive reinforcement messages, which could improve adherence and outcomes. This trial aims to discover if syncing eating patterns with the body's internal clock can offer a complementary benefit to existing cancer treatments.

What evidence suggests that this time-restricted diet intervention is effective for brain metastases?

Research shows that time-restricted eating, such as the txt4fasting program, can improve health. In this trial, participants in Arm I will follow a time-restricted diet using the txt4fasting platform, which includes receiving interactive positive reinforcement messages and recording food intake. Studies have found that simply changing when one eats can help with heart disease risks, weight control, and reduce chemotherapy side effects. Early results suggest this eating pattern might also lower the chance of cancer returning and improve the quality of life for cancer patients. Specifically, for people with breast cancer, longer fasting at night has been linked to a lower risk of recurrence. Overall, txt4fasting may help reduce brain function decline and possibly improve survival for those receiving precise brain radiation treatment for cancer spread from breast or lung cancer. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for breast or lung cancer patients with brain metastases, who will undergo stereotactic radiosurgery. It's designed to see if a special diet plan that changes when you eat can help reduce mental decline and improve survival rates.

Inclusion Criteria

Willing and able to comply with the protocol for the duration of the study

Body mass index (BMI) ≥ 25 kg/m^2

Able to speak, read and write English

Exclusion Criteria

Inability to tolerate a normal diet (may include an active malabsorption syndrome at the time of consent [i.e. Crohn's disease, major bowel resection leading to permanent malabsorption])

Not a SRS candidate as determined by the treating physician

I have not had brain surgery in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants follow a time-restricted diet and receive interactive messages for 30 days, with counseling calls and food intake recording

4 weeks

Counseling calls twice weekly in weeks 1 and 2, then once weekly in weeks 3 and 4

Stereotactic Radiosurgery (SRS)

Participants undergo stereotactic radiosurgery and have blood samples and brain MRI collected

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at 3 and 6 months

6 months

Follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Interactive Time-Restricted Diet Intervention (txt4fasting)

Trial Overview The study tests an interactive diet intervention called txt4fasting, which involves time-restricted eating to potentially benefit the brain after radiation therapy. Patients will also receive dietary counseling and be monitored through various assessments and imaging.

How Is the Trial Designed?

Group I: Arm I (txt4fasting) Experimental Treatment 10 Interventions

Patients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.

Group II: Arm II (attention control) Active Control 8 Interventions

Patients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

A pilot study involving 40 women with a history of early-stage breast cancer showed that prolonged overnight fasting (POF) for 13 hours was feasible, with 95% of participants successfully fasting for at least 70% of the study nights.

Participants experienced significant improvements in anxiety, BMI, depression, and fatigue after 12 weeks of fasting, suggesting that POF may be a beneficial nonpharmacological intervention for improving certain health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). O'Donnell, E., Shapiro, Y., Comander, A., et al.[2022]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

Time-restricted feeding (TRF) significantly reduced the expression of genes related to lipid metabolism in mammary tumors, suggesting a potential mechanism for its protective effects against tumor development.

Despite TRF not altering the overall metabolic profile of the tumors, its protective effects may be due to changes in the host's biological pathways rather than direct effects on tumor metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolome of Mammary Tumors Differs from Normal Mammary Glands But Is Not Altered by Time-restricted Feeding Under Obesogenic Conditions. Yan, L., Sundaram, S., Rust, BM., et al.[2020]

Time-restricted feeding (TRF) effectively reduces mammary tumor growth and metastasis in mouse models of obesity-driven postmenopausal breast cancer without requiring calorie restriction or weight loss.

TRF improves insulin sensitivity and normalizes circadian gene expression in tumors, indicating that its cancer-fighting effects may be linked to its ability to lower hyperinsulinemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding normalizes hyperinsulinemia to inhibit breast cancer in obese postmenopausal mouse models. Das, M., Ellies, LG., Kumar, D., et al.[2023]

Time-restricted feeding (TRF) significantly reduces the risk of obesity-related metastasis in a mouse model of lung cancer, as shown by lower numbers and sizes of lung metastases compared to those on a high-fat diet (HFD).

TRF also effectively prevents increases in harmful substances like glucose, insulin, and proinflammatory cytokines that are typically elevated by a high-fat diet, suggesting a protective mechanism against cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Feeding Attenuates High-fat Diet-enhanced Spontaneous Metastasis of Lewis Lung Carcinoma in Mice. Yan, L., Sundaram, S., Mehus, AA., et al.[2019]

Chronic dietary restriction, specifically a 50% reduction in diet for one week before and three weeks after tumor inoculation, significantly reduces lung metastasis in rats, indicating a potential strategy for inhibiting tumor growth.

The study found that preexposure to dietary restriction is crucial for reducing tumor colonization, and this effect may be linked to increased activity of natural killer cells shortly after tumor inoculation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic dietary restriction influences tumor metastasis in the rat: parametric considerations. Hodgson, DM., Chiappelli, F., Morrow, NS., et al.[2007]

Time-restricted feeding during the dark phase significantly reduced the risk of mammary tumor development in mice fed a high-fat diet (HFD), suggesting a protective effect against tumorigenesis.

The study found that while the HFD group had increased body fat and tumor progression, the restricted feeding group maintained body fat levels similar to a standard diet, indicating that timing of food intake may influence metabolic health and cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding mitigates high-fat diet-enhanced mammary tumorigenesis in MMTV-PyMT mice. Sundaram, S., Yan, L.[2019]

A moderate dietary restriction of 30-40% significantly reduced the growth of malignant brain tumors in mice by nearly 80%, indicating its potential as a therapeutic strategy.

The study found that dietary restriction led to lower tumor blood vessel density and increased tumor cell death, suggesting it may shift the tumor environment to inhibit growth and promote apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary restriction reduces angiogenesis and growth in an orthotopic mouse brain tumour model. Mukherjee, P., El-Abbadi, MM., Kasperzyk, JL., et al.[2022]

Short-term dietary restriction, involving alternate day feeding and fasting, significantly improved survival rates in tumor-bearing Fisher rats, with 66.7% surviving 9 days post-tumor inoculation compared to only 20.8% in the control group.

The study suggests that mild dietary restrictions could be beneficial in enhancing survival and potentially inhibiting cancer growth, indicating a need for further clinical trials in human cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term dietary restriction on survival of mammary ascites tumor-bearing rats. Siegel, I., Liu, TL., Nepomuceno, N., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06315296

An Interactive Time-Restricted Diet Intervention (txt4fasting) ... Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01392

An Interactive Time-Restricted Diet Intervention (txt4fasting) ... Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain ...

3. withpower.com withpower.com/trial/time-restricted-diet-for-brain-metastases-8ba16

Time-Restricted Diet for Brain Metastases Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime ...

4. academic.oup.com 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating & cancer: lessons learned In addition to improved HbA1c, prolonged nightly fasting was associated with a statistically significant lower risk of disease recurrence in a cohort of breast ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06315296?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(restriction%20dermopathy%20OR%20%22lethal%20hyperkeratosis-contracture%20syndrome%22%20OR%20%22%20lethal%20restrictive%20dermopathy%22%20OR%20%22%20lethal%20tight%20skin-contracture%20syndrome%22%20OR%20%22%20tight%20skin%20contracture%20syndrome%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING))))&rank=7

An Interactive Time-Restricted Diet Intervention (txt4fasting) ... This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11107340/

Effect of time-restricted eating and intermittent fasting on ... The findings suggest that TRE and IFA may have a positive impact on cognitive function and mental health in this population.