Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer
You may be eligible to participate in this one month research study if you are:
- An adult with metastatic cancer (especially breast, colon, cervical, endometrial,
ovarian; others may qualify) that has resisted prior attempts to treat it with courses
of chemotherapy; or if you decline chemotherapy or are looking for a break, or you seek
an alternative to medicines or therapies due to toxic effects.
- Your tumor has shown up on a PET scan.
- Willing to closely follow a diet and strictly limit your carbohydrate intake.
You will not be eligible to participate if you:
- Have heart or liver condition or any other disease or condition that makes it difficult
or medically hazardous (determined by your doctor) for you to follow the diet
recommended for this study.
- Have kidney or kidney stone disease.
- We will obtain a PET/CT scan to determine your eligibility if you are otherwise
interested in this protocol.
- We will also obtain a second PET/CT scan at the end of the dietary trial (28 days).
- We will also obtain blood and urine tests at weekly intervals during the trial.
Visits and contacts:
- We will see you once/week for four weeks on the Albert Einstein, or Montefiore Medical
Center Campus (your choice) for a total of 5 visits, and will call you on the phone at
least one additional time each week. The first visit will take approximately one hour
or as long as is needed to understand the diet correctly. The remaining visits will
take approximately one-half hour. The PET/CT scan will take approximately 25 minutes in
the camera. Waiting time varies for the procedure but is usually less than 20 minutes.
- Low carbohydrate supplement shakes will be given to all participants.
- All procedures and visits are without cost to the subject.
- There are no funds for direct compensation.
Description of the Intervention:
- The diet will severely restrict carbohydrates (that is, NO sugars or starches; no
bread, pasta, rice, sugary drinks, potatoes or potato chips, cake, cookies, ice cream,
- You will be allowed to eat AS MUCH AS YOU LIKE of foods that have very small amounts of
carbohydrate, such as eggs, beef, poultry, fish, salads (except potatoes and other
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days
28 day trial
Eugene Fine, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Institutional Review Board
|The Albert Einstein College of Medicine of Yeshiva University||Bronx, New York 10461|