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Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer


N/A
21 Years
N/A
Not Enrolling
Both
Cancer, Breast Cancer, Colon Cancer, Cervical Cancer, Uterine Cancer, Ovarian Cancer

Thank you

Trial Information

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.

Procedures:

- 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.

Compensation:

- 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,
etc).

- 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
starchy vegetables).


Inclusion Criteria:



- You're an adult with metastatic cancer (breast, colon; others may qualify) that has
been resistant to chemotherapy or would like a break from chemotherapy.

- Your tumor shows up on a PET or PET/CT scan.

- You are willing to closely follow a diet which strictly limits your carbohydrate
intake (sugars, starches, etc). We will help you with nutrition counseling but you
must prepare your meals, or have someone help you prepare your meals.

- You are able to come to the Albert Einstein College of Medicine in Bronx, NY for an
initial evaluation appointment and weekly nutrition counseling appointments for a
four-week period.

Exclusion Criteria:

- Have a heart condition, liver condition or any other disease or condition that makes
it difficult or medically hazardous (as determined by your doctor) for you to follow
the study diet.

- Have kidney or kidney stone disease.

- Are too thin or have lost too much weight.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days

Outcome Time Frame:

28 day trial

Safety Issue:

Yes

Principal Investigator

Eugene Fine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Institutional Review Board

Study ID:

2004-064

NCT ID:

NCT00444054

Start Date:

February 2006

Completion Date:

May 2012

Related Keywords:

  • Cancer
  • Breast Cancer
  • Colon Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Ovarian Cancer
  • Diet
  • Cancer
  • Alternative
  • Breast
  • Colon
  • Cervix
  • Uterus
  • Ovary
  • Metastatic
  • Nutrition
  • Carbohydrate
  • Breast Neoplasms
  • Colonic Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms

Name

Location

The Albert Einstein College of Medicine of Yeshiva UniversityBronx, New York  10461