The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

NCT00444054 | Completed DMC

• 1 other identifier: 2004-064
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.).

Conditions

Cancer; Breast Cancer; Colon Cancer; Cervical Cancer; Uterine Cancer; Ovarian Cancer

Keywords

Diet; Cancer; Alternative; Breast; Colon; Cervix; Uterus; Ovary; Metastatic; Nutrition; Carbohydrate

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (1)

• Safety of a very low carbohydrate diet in individuals with metastatic cancer

  28 days

Study Arms (1)

Dietary modification

EXPERIMENTAL

Patients are placed on a low carbohydrate diet (\<30 grams/day) for 28 days.

Behavioral: Very low carbohydrate diet (approximately 20 grams per day)

Interventions

Very low carbohydrate diet (approximately 20 grams per day) BEHAVIORAL

Very low carbohydrate diet for a duration of four weeks.

Dietary modification

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Robert C. Atkins Foundation: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

The Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• 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.

  PMID: 19480693 BACKGROUND

• Fine 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

  BACKGROUND

Related Links

• The RECHARGE Trial at The Albert Einstein College of Medicine
• Faculty Profile Site for Eugene Fine, Principle Investigator

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colonic Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Ovarian Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugene Fine, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• C.J. Segal-Isaacson, EdD, RD

  Albert Einstein College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: February 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2012
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

US (1)