Low Calorie Diet for Cancer

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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well a controlled low calorie diet works in reducing side effects and increasing response to chemotherapy in patients with breast or prostate cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Eating a special diet with low calories may reduce the side effects of chemotherapy and improve the response to treatment

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 data supports the effectiveness of the treatment Controlled Low Calorie Diet for cancer?

Research suggests that a low-calorie diet can help with weight loss and improve health in cancer survivors, which may be important for cancer prognosis. Additionally, reducing calorie intake has been shown to help control weight and reduce treatment side effects during chemotherapy. ^{1 2 3 4 5}

Is a low-calorie diet safe for cancer patients?

Research suggests that short-term calorie reduction is generally safe and well-tolerated in cancer patients, with studies showing good compliance and stable nutritional status. However, more studies are needed to confirm its safety across different types of cancer. ^{1 6 7 8 9}

How does the low calorie diet treatment for cancer differ from other treatments?

The low calorie diet treatment for cancer is unique because it involves reducing overall food and calorie intake without causing nutritional deficiencies, which can inhibit tumor growth by reducing blood vessel formation (angiogenesis) and increasing cell death (apoptosis) in tumors. This approach is different from traditional cancer treatments like chemotherapy or radiation, as it focuses on altering the tumor's environment and metabolism rather than directly targeting cancer cells. ^{10 11 12 13 14}

Research Team

Priya Jayachandran, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]

2. England 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. [2022]

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

Nutritional support in the cancer-bearing host. Effects on host and tumor. [2019]

4. United States 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. [2021]

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

Cancer, cancer cachexia, and diet: lessons from clinical research. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Effects of Short-Term Calorie Reduction during Induction Chemotherapy in Patients with Diffuse Large B-Cell Lymphoma: A Pilot Study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Energy and caloric restriction, and fasting and cancer: a narrative review. [2021]

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

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes. [2023]

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

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

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

Effects of caloric restriction and dietary fat on epithelial cell proliferation in rat colon. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Dietary restriction reduces angiogenesis and growth in an orthotopic mouse brain tumour model. [2022]

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

Caloric restriction augments radiation efficacy in breast cancer. [2021]

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

Influence of caloric intake on experimental carcinogenesis: a review. [2019]