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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
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 belowSelect...
I am fully active or can carry out light work.
Select...
I have breast cancer treated with AC or metastatic prostate cancer treated with Docetaxel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
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
3,227 Previous Clinical Trials
3,771,538 Total Patients Enrolled
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University of Southern CaliforniaLead Sponsor
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1,595,919 Total Patients Enrolled
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9,422 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
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Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have diabetes.I have been treated with IGF-1 inhibitors before.I am currently taking somatostatin.I have breast cancer treated with AC or metastatic prostate cancer treated with Docetaxel.I have breast cancer and haven't had chemotherapy, except possibly for another cancer over 3 years ago.I experience mild to severe numbness or pain in my hands or feet.I have prostate cancer and may have been treated with cyclophosphamide.I finished my radiotherapy at least 2 weeks ago.I can receive chemotherapy regardless of my cancer's current measurement status.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (normal diet)
- Group 2: Arm I (low-calorie diet)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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