Low Calorie Diet for Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavid I Quinn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

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

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)

+9 more

Exclusion Criteria

I have diabetes.

I have been treated with IGF-1 inhibitors before.

I am currently taking somatostatin.

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (low-calorie diet)Experimental Treatment2 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 Control2 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.