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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

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 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

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

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,298 Previous Clinical Trials
3,958,315 Total Patients Enrolled
37 Trials studying Prostate Cancer
8,578 Patients Enrolled for Prostate Cancer
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,351 Total Patients Enrolled
18 Trials studying Prostate Cancer
9,422 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,870 Total Patients Enrolled
567 Trials studying Prostate Cancer
529,809 Patients Enrolled for Prostate Cancer

Media Library

dietary intervention Clinical Trial Eligibility Overview. Trial Name: NCT01802346 — N/A
Prostate Cancer Research Study Groups: Arm II (normal diet), Arm I (low-calorie diet)
Prostate Cancer Clinical Trial 2023: dietary intervention Highlights & Side Effects. Trial Name: NCT01802346 — N/A
dietary intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT01802346 — N/A
~4 spots leftby Jan 2025
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