Low Calorie Diet for Cancer

Not currently recruiting at 2 trial locations

Overseen By Cheryl Kefauver, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: IGF-1 inhibitors, Somatostatin

Disqualifiers: Diabetes, Peripheral neuropathy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special low-calorie diet can improve well-being and chemotherapy response in individuals with breast or prostate cancer. Chemotherapy aims to kill cancer cells or stop them from dividing. Participants will either maintain a regular diet or follow a carefully controlled low-calorie diet (Controlled Low Calorie Diet) during their chemotherapy treatments. This trial targets individuals with breast cancer requiring specific chemotherapy drugs or prostate cancer requiring Docetaxel, with a body mass index (BMI) of at least 18.5. However, it excludes those with diabetes or certain food allergies. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches that may enhance the treatment experience.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude those using somatostatin and those with diabetes, which might imply some restrictions. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that a controlled low calorie diet is safe for cancer patients?

Research shows that a low-calorie diet might benefit people undergoing chemotherapy. Studies have found that patients consuming fewer calories may experience better outcomes during cancer treatment. Specifically, they might face fewer side effects and respond more effectively to chemotherapy.

Although large studies have not proven that this diet can "cure" cancer, smaller studies suggest it might aid during treatment. The diet has been tested on patients without major safety concerns. However, individual differences exist, so consulting a healthcare provider before changing one's diet is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-calorie diet approach for cancer treatment because it focuses on managing dietary intake to potentially enhance the effectiveness of chemotherapy. Unlike typical cancer treatments that rely heavily on drugs or radiation, this method uses a controlled low-calorie diet to possibly improve how well the body responds to chemotherapy. By specifically providing all meals and maintaining strict dietary control during and around chemotherapy sessions, this approach aims to optimize the body's condition to support cancer treatment. This dietary strategy is a unique complement to current standard therapies, offering a non-invasive way to potentially boost treatment outcomes.

What evidence suggests that a controlled low calorie diet might be an effective treatment for reducing side effects and increasing response to chemotherapy in breast or prostate cancer?

Research has shown that eating fewer calories might help cancer patients undergoing chemotherapy. Early studies suggest that patients who eat less often respond better to chemotherapy and experience fewer side effects. One study found that reducing calorie intake can slow tumor growth, regardless of the foods included in the diet. Another review of various diet plans supports the idea that eating less can aid cancer treatment. In this trial, some participants will follow a low-calorie diet, potentially enhancing the effectiveness of chemotherapy for patients with breast and prostate cancer, while others will maintain a normal diet for comparison. ^{1 2 4 6 7}

Who Is on the Research Team?

Darcy Spicer, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults with breast or prostate cancer who haven't had certain prior treatments and have a BMI of at least 18.5. They should not have diabetes, significant food allergies, or peripheral neuropathy. Women must test negative for pregnancy and agree to use barrier contraception.

Inclusion Criteria

I have prostate cancer and saw improvement with my first round of docetaxel, taken 9+ months ago.

I am fully active or can carry out light work.

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2x upper limit of normal (ULN)

Exclusion Criteria

I have diabetes.

I have been treated with IGF-1 inhibitors before.

I am currently taking somatostatin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a special low-calorie diet for 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 24 hours after chemotherapy. They are provided with all meals and maintain a food diary.

12 weeks

Meet with study dietician within 3 weeks of enrollment and prior to each chemotherapy course

Chemotherapy

Participants receive chemotherapy while following their assigned diet (low-calorie or normal diet).

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tumor response and chemotherapy-related toxicity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Controlled Low Calorie Diet

Trial Overview The study is testing if a controlled low calorie diet can reduce chemotherapy side effects and improve treatment response in patients with breast or prostate cancer undergoing specific chemotherapy regimens.

How Is the Trial Designed?

Group I: Arm I (low-calorie diet) Experimental Treatment 2 Interventions

Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 2 days after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts.

Group II: Arm II (normal diet) Active Control 2 Interventions

Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A workshop by the National Institutes of Health highlighted the need for baseline screening for malnutrition risk in cancer patients, recommending that this screening be repeated during and after treatment to ensure proper nutritional support.

Current evidence shows that while nutritional interventions may help reduce malnutrition-related issues in cancer patients, many studies are of low quality and inconsistent, indicating a strong need for more rigorous research to determine their true effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. Hiatt, RA., Clayton, MF., Collins, KK., et al.[2023]

Caloric restriction, even as low as 10%, significantly inhibits tumor growth in rodents, with a notable 40% caloric restriction leading to substantial reductions in mammary and colonic tumors.

Exercise also plays a crucial role in reducing tumor incidence, as sedentary rats showed a 108% higher rate of colon tumors compared to those that exercised regularly, highlighting the importance of both diet and physical activity in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of caloric restriction and exercise on tumorigenesis in rats. Kritchevsky, D.[2020]

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]

The ERGO2 trial, involving 50 patients with recurrent brain tumors, found that a calorie-restricted ketogenic diet combined with intermittent fasting did not improve progression-free survival compared to a standard diet, despite achieving significant metabolic changes in those on the ketogenic diet.

Patients on the ketogenic diet successfully met their dietary goals, leading to notable decreases in leptin and insulin levels, while low glucose levels were identified as a potential marker for better prognosis, although quality of life and cognitive function remained unaffected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Voss, M., Wenger, KJ., von Mettenheim, N., et al.[2022]

Caloric restriction significantly inhibits tumor growth, with the most effective results seen when restriction is maintained during both the initiation and promotion phases of tumor development.

A diet low in calories but high in fat is more effective at reducing tumor incidence compared to a high-calorie, low-fat diet, as demonstrated in studies with mice showing up to 61% fewer tumors with high fat, low calorie diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of caloric intake on experimental carcinogenesis: a review. Kritchevsky, D., Klurfeld, DM.[2019]

In murine models of triple-negative breast cancer (TNBC), a daily caloric restriction (CR) of 30% combined with radiation therapy (IR) resulted in greater tumor regression compared to either treatment alone, highlighting the potential of dietary modification as a therapeutic intervention.

Molecular analysis revealed that CR and IR together reduced tumor cell proliferation and increased apoptosis, with downregulation of key components in the IGF-1R pathway, suggesting that targeting this pathway could enhance treatment efficacy for TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caloric restriction augments radiation efficacy in breast cancer. Saleh, AD., Simone, BA., Palazzo, J., et al.[2021]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Caloric restriction significantly reduces colonic cell proliferation (CCP), which is a marker for colon cancer risk, in both high-fat and low-fat diet groups of rats treated with a carcinogen.

While a high-fat diet did not increase CCP in the distal colon, it was associated with a higher tumor yield, indicating that dietary fat influences cancer risk differently than caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of caloric restriction and dietary fat on epithelial cell proliferation in rat colon. Steinbach, G., Kumar, SP., Reddy, BS., et al.[2013]

A survey of 14 Dutch Head and Neck Oncology centres revealed significant variations in nutritional interventions during chemoradiotherapy, particularly in the use of gastrostomy for tube feeding, with 77% of centres using it for most patients.

There is a need for standardized dietetic guidelines, as practices varied widely, including the number of dietetic consultations (2 to 7), methods for calculating energy and protein requirements, and the timing for removing gastrostomies after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional interventions in patients with head and neck cancer undergoing chemoradiotherapy: Current practice at the Dutch Head and Neck Oncology centres. Kok, A., van der Lugt, C., Leermakers-Vermeer, MJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8749320/

Calorie Restriction for Cancer Prevention and Therapy Preliminary clinical studies show that patients subjected to a reduced nutrient/energy intake experience improved outcomes from chemo- and radiotherapy while ...

2. nature.com nature.com/articles/s41467-021-26431-4

Daily caloric restriction limits tumor growth more effectively ... Results. Low-calorie cycles slow tumor growth independent of diet composition. The impact of diet composition and 4:10 feeding cycles on the ...

3. academic.oup.com academic.oup.com/jnci/article/116/7/1026/7617726

Dietary interventions in cancer: a systematic review of all ... In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S089990072030112X

Assessing successful completion of calorie restriction ... Calorie restriction (CR) >20% has been hypothesized to aid cancer prevention and treatment. Yet, to our knowledge, there is a lack of reported studies in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01802346

NCT01802346 | Controlled Low Calorie Diet in Reducing ... This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7476366/

Fasting and Caloric Restriction in Cancer Prevention and ... “Controlled low calorie diet in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer”, Assessments of a ...

7. jcpjournal.org jcpjournal.org/journal/view.html?uid=877&vmd=Full

Calorie Restriction for Cancer Prevention and Therapy Preliminary clinical studies show that patients subjected to a reduced nutrient/energy intake experience improved outcomes from chemo- and ...