low carb clinical trial
RECHARGE Low Carbohydrate Diet Study for Metastatic Cancer
Patient Abstract The two major goals of the RECHARGE Study are to determine:
-Whether a very low carbohydrate diet can help participants reduce the amount of cancer in their bodies (as measured by a PET scan at the beginning and end of the study).
-Whether participants can feel well while maintaining their weight on a very low carbohydrate diet.
This research study is for people with advanced cancers who want to take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples of such cancers include metastatic breast cancer, colon cancer and many others.
Our intervention consists of a 28 day diet of high protein foods such as fish, poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much of the high protein foods as they wish and can eat up to two cups of vegetables per day.
Participants strictly eliminate carbohydrate-containing foods. These foods include all starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with sugar, etc.).
You may be eligible to participate in this one month research study if you are:
-An adult with metastatic cancer (especially breast or colon; others may qualify) that has resisted prior attempts to treat it with courses of chemotherapy.
-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, Montefiore or Jacobi campus (your choice) (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, potato 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 (excepting potato and other starchy vegetables).
Comments
-
Study
Hi Nancy,
This looks like a very interesting study. I did a doctor monitored protein fast years ago to lose weight-strictly protein. I found it very tolerable and energizing. I know a lot of doc don't approve of this kind of diet, it was 500 calories a day to start. It worked very well, but I gained all of it back eventually. I was monitored very carefully with labs to make sure there was no damage from the diet.
I did have a great shake, but I don't have the name of it. It had no sugar and could be used in place of a meal. I remember mixing it up in the airport, since there was nothing I could eat there! I'm not sure if it was sold outside of a Doctor's program....
I'm not sure I have the willpower to do this diet all the time, but if it meant life over death, I would and could do it....
It is so amazing sometimes to try to find a product without sugar that is 100% protein(or any product that doesn't have sugar!). I had one Kosher hot dog I could eat that was without sugar.
I think you have to be near a major city to get in a lot of these studies-kind of sad...
Thanks for the update....Ginny0 -
Fiberfroggy1 said:Study
Hi Nancy,
This looks like a very interesting study. I did a doctor monitored protein fast years ago to lose weight-strictly protein. I found it very tolerable and energizing. I know a lot of doc don't approve of this kind of diet, it was 500 calories a day to start. It worked very well, but I gained all of it back eventually. I was monitored very carefully with labs to make sure there was no damage from the diet.
I did have a great shake, but I don't have the name of it. It had no sugar and could be used in place of a meal. I remember mixing it up in the airport, since there was nothing I could eat there! I'm not sure if it was sold outside of a Doctor's program....
I'm not sure I have the willpower to do this diet all the time, but if it meant life over death, I would and could do it....
It is so amazing sometimes to try to find a product without sugar that is 100% protein(or any product that doesn't have sugar!). I had one Kosher hot dog I could eat that was without sugar.
I think you have to be near a major city to get in a lot of these studies-kind of sad...
Thanks for the update....Ginny
Dear Nancy
Is there any source of fiber in this diet?
It is very interesting for me to know the result.My concern is the fiber intake which has an important role in bowel movements and a healthy digestive system .0 -
clinical trial
This trial is being offered at a major medical center in the Bronx. It is offered at Montefiore, Albert Einstein Medical and Jacobi. All three hospitals are linked in care. Anyone living a distance outside the metro area may not be familiar with these hospitals but they are major medical centers.0 -
Low Carb Diet
Hi Nancy,
You know? I've been hearing about the connection between too much sugar in our diets and certain cancers.
I hate that the study isn't here, but I will double check on perhaps a similiar study in this vicinity.
If there isn't; thank you for providing enough of the protocol as to what can and can't be eaten on this plan.
Again, thanks for giving info that gives me a bit of direction. I have one more taxol treatment to go and (hopefully), afterwards I would love to purge this decadron(steriods) with a healthy/cleansing diet out of my body and get back to an active sensible lifestyle.
It's been a bit hard for me due to my 24/7 eating lately.
Love,
Sharon0 -
Hardmsfanciful said:Low Carb Diet
Hi Nancy,
You know? I've been hearing about the connection between too much sugar in our diets and certain cancers.
I hate that the study isn't here, but I will double check on perhaps a similiar study in this vicinity.
If there isn't; thank you for providing enough of the protocol as to what can and can't be eaten on this plan.
Again, thanks for giving info that gives me a bit of direction. I have one more taxol treatment to go and (hopefully), afterwards I would love to purge this decadron(steriods) with a healthy/cleansing diet out of my body and get back to an active sensible lifestyle.
It's been a bit hard for me due to my 24/7 eating lately.
Love,
Sharon
It is so hard to know what to eat and what not to eat. You guys have inspired me to do better too. I try really hard to stick to my Weight Watchers diet. I would love to know more about IV therapy vitamin and chelation. Also a good cleanse. My Dr. told me that yeast is a big problem for patients who have had or are on Chemo. Does anyone do anything for yeast or have a problem? It is a big problem for me. He also told me to keep my meals simple and to take probiotics to help with digestion. I am taking the approach of keeping my system running the best that it can to maximize my immune response. Good book too by author Masaru Emoto. He has a few. I am reading "The Miracle of Water". It is hopeful and inspiring.
Deb0
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