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Low Calorie Diet for Cancer

N/A
Recruiting
Led By Priya Jayachandran, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of chemotherapy-related toxicity
Secondary outcome measures
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
3,176 Previous Clinical Trials
3,757,931 Total Patients Enrolled
82 Trials studying Breast Cancer
13,916 Patients Enrolled for Breast Cancer
University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,595,183 Total Patients Enrolled
11 Trials studying Breast Cancer
4,414 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,526 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,213 Patients Enrolled for Breast Cancer

Media Library

dietary intervention Clinical Trial Eligibility Overview. Trial Name: NCT01802346 — N/A
Breast Cancer Research Study Groups: Arm II (normal diet), Arm I (low-calorie diet)
Breast 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people will be taking part in this experiment at most?

"That is accurate, the website clinicaltrials.gov has information indicating that this trial is looking for more participants. The original posting date was 29 January 2013 with the most recent update on 16 November 2021. So far, 3 locations have enrolled a total of 120 people between them."

Answered by AI

Are there any spots available in this clinical trial for new patients?

"Yes, this is an active recruitment according to the information available on clinicaltrials.gov. The study was first posted on 1/29/2013 and was last updated on 11/16/2021. They are looking for a total of 120 patients at 3 different sites."

Answered by AI
~10 spots leftby Mar 2025