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Low Calorie Diet for Cancer

N/A

Waitlist Available

Led By David I Quinn, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic prostate adenocarcinoma for which Docetaxel will be administered

Must not have

Diabetes Mellitus

Prior therapy with inhibitors of IGF-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a low calorie diet can help reduce side effects and improve response to chemo for breast or prostate cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial aims to reduce side effects through diet, typical chemo side effects may include nausea, fatigue, hair loss, increased infection risk, and potential digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have breast cancer treated with AC or metastatic prostate cancer treated with Docetaxel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have been treated with IGF-1 inhibitors before.

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I am currently taking somatostatin.

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I experience mild to severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of chemotherapy-related toxicity

Secondary study objectives

Neoplasms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dietary intervention

2000

Completed Phase 2

~600

0 / 6Eligibility criteria met