The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer
Ključne besede
Povzetek
Opis
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).
Datumi
| Nazadnje preverjeno: | 09/30/2020 |
| Prvič predloženo: | 03/04/2007 |
| Predviden vpis oddan: | 03/04/2007 |
| Prvič objavljeno: | 03/06/2007 |
| Zadnja posodobitev oddana: | 10/28/2020 |
| Zadnja posodobitev objavljena: | 10/29/2020 |
| Dejanski datum začetka študija: | 01/31/2006 |
| Predvideni datum primarnega zaključka: | 04/30/2010 |
| Predvideni datum zaključka študije: | 04/30/2012 |
Stanje ali bolezen
Intervencija / zdravljenje
Behavioral: Dietary modification
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Dietary modification Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days. | Behavioral: Dietary modification Very low carbohydrate diet for a duration of four weeks. |
Merila upravičenosti
| Starost, primerna za študij | 21 Years Za 21 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days [28 day trial]
Ukrepi sekundarnega rezultata
1. Safety of a very low carbohydrate diet in individuals with metastatic cancer [28 days]
