CancerRECHARGENCT00444054
The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer
A study testing Very low carbohydrate diet (approximately 20 grams per day) in people with Cancer and Breast Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This study is for people whose cancer: has resisted chemotherapy are taking a break from chemotherapy or are looking for an alternative to the toxic effects of chemotherapy The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- Very low carbohydrate diet (approximately 20 grams per day)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, 10461
About this study
Official title: Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer
This study is for people whose cancer:
- has resisted chemotherapy
- are taking a break from chemotherapy
- or are looking for an alternative to the toxic effects of chemotherapy
Read more
The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers.
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 decline chemotherapy or 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, cervical and uterine cancers, ovarian cancers, and many others.
The investigators' 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.).
Read the detailed description
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).
- Conditions
- Cancer, Breast Cancer, Colon Cancer, Cervical Cancer, Uterine Cancer, Ovarian Cancer
- Being tested
- Very low carbohydrate diet (approximately 20 grams per day)
- Keywords
- Diet, Cancer, Alternative, Breast, Colon, Cervix, Uterus, Ovary, Metastatic, Nutrition, Carbohydrate
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colonic Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low carbohydrate diet (approximately 20 grams per day)Behavioural
Very low carbohydrate diet for a duration of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary modification | Experimental | Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days. Receives: Behavioral: Very low carbohydrate diet (approximately 20 grams per day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days
Measured: 28 day trial
Secondary outcomes (1)
Safety of a very low carbohydrate diet in individuals with metastatic cancer
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startFeb 2006
- Primary completionMay 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation, Montefiore Medical Center
- Responsible party
- Principal investigator, Eugene Fine, Albert Einstein College of Medicine
- Investigators
- Eugene Fine, MD, Principal investigator, Albert Einstein College of MedicineC.J. Segal-Isaacson, EdD, RD, Study director, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444054
- Sponsor's protocol ID
- 2004-064
- Acronym
- RECHARGE
- Status last verified
- Oct 2020
- First submitted
- 5 Mar 2007
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14.
PubMed 19480693Fine EJ, Segal-Isaacson CJ, Feinman R, Sparano J: Carbohydrate restriction in patients with advanced cancer: a protocol to assess safety and feasibility with an accompanying hypothesis. Commun Oncol 2008;5:22-26
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00444054
- Acronym / sponsor ID
- RECHARGE / 2004-064
- Conditions
- Cancer, Breast Cancer, Colon Cancer, Cervical Cancer, Uterine Cancer, Ovarian Cancer
- Keywords
- Diet, Cancer, Alternative, Breast, Colon, Cervix, Uterus, Ovary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation, Montefiore Medical Center
- Study start
- Feb 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for people whose cancer:
- has resisted chemotherapy
- are taking a break from chemotherapy
- or are looking for an alternative to the toxic effects of chemotherapy
The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers.
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 decline chemotherapy or 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, cervical and uterine cancers, ovarian cancers, and many others.
The investigators' 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.).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary modification | Experimental | Behavioral: Very low carbohydrate diet (approximately 20 grams per day)Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low carbohydrate diet (approximately 20 grams per day)Very low carbohydrate diet for a duration of four weeks. | Behavioural | Dietary modification |
Primary outcome
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days
Time frame: 28 day trial
1 secondary outcome
Safety of a very low carbohydrate diet in individuals with metastatic cancer
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Background: PubMed 19480693Fine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14.
- BackgroundFine EJ, Segal-Isaacson CJ, Feinman R, Sparano J: Carbohydrate restriction in patients with advanced cancer: a protocol to assess safety and feasibility with an accompanying hypothesis. Commun Oncol 2008;5:22-26
- The RECHARGE Trial at The Albert Einstein College of MedicineLink provided by the sponsor.
- Faculty Profile Site for Eugene Fine, Principle InvestigatorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Fine, MD principal investigator
Albert Einstein College of Medicine
C.J. Segal-Isaacson, EdD, RD study director
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low carbohydrate diet (approximately 20 grams per day) in people with Cancer and Breast Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days (time frame: 28 day trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.