Overview

This trial is active, not recruiting.

Conditions endometrial cancer, obesity
Treatments dietary intervention, informational material, dietary education, weight maintenance, average score of obesity and weight-loss quality of life questionnaire
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2014
End date March 2017
Trial size 11 participants
Trial identifier NCT02135562, CASE 1814, CASE1814, NCI-2014-00832, P30CA043703

Summary

This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participants will take part in a Protein-Sparing Modified Fast (PSMF) Intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks or until they have loss 15% of their body weight. This intervention will be followed by weight maintenance in which participants reintroduce non-starchy vegetables to their diet. At this time participants will also receive informational material and dietary education which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight-Loss Quality of Life Questionnaire to survey the impact of the intervention
dietary intervention Dietary Modification
Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.
informational material
Receive carbohydrate reintroduction handout
dietary education intervention, educational
Receive education on nutrition label reading for carbohydrates
weight maintenance
weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited
average score of obesity and weight-loss quality of life questionnaire
Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.

Primary Outcomes

Measure
Mean Weight loss assessed with the digital scale
time frame: Baseline up to 6 months
Mean Weight loss assessed with the digital scale
time frame: Baseline up to 12 months

Secondary Outcomes

Measure
Changes in levels of total cholesterol
time frame: Baseline up to 6 months
Changes in levels of markers of inflammation (C-reactive protein)
time frame: Up to 6 months
Changes in levels of glucose
time frame: Up to 6 months
Number of drop-out participants
time frame: Up to 6 months
Average percentage of positive urinary ketone tests as a marker of dietary adherence
time frame: Up to 6 months
Number of Participant with reported side effects
time frame: Up to 6 months
Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire
time frame: Baseline up to 6 months
Changes in levels of markers of inflammation (interleukin 6)
time frame: Up to 6 months
Changes in levels of markers of inflammation (tumor necrosis factor - alpha)
time frame: Up to 6 months
Changes in levels of markers of inflammation (leptin)
time frame: Up to 6 months
Changes in levels of LDL-cholesterol
time frame: Baseline up to 6 months
Changes in levels of HDL-cholesterol
time frame: Baseline up to 6 months
Changes in levels of triglycerides
time frame: Baseline up to 6 months

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - Previous diagnosis of endometrial cancer, successfully treated through surgery - Body mass index (BMI) > 30 kg/m^2 - > 8 weeks removed from surgery to treat endometrial cancer Exclusion Criteria: - No previous diagnosis of endometrial cancer - BMI < 30 kg/m^2 - Any history of cardiovascular, kidney, or liver disease - Using medication to treat diabetes - History of cardiac arrhythmias - Inability to comply with follow up regimen - Inability to read or speak English - Abstention from meat and other animal products

Additional Information

Official title A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
Principal investigator Kimberly Resnick
Description PRIMARY OBJECTIVES: I. Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer survivors (ECS). II. To assess whether the approach is feasible, whether participants will remain in the study for the duration of the intervention while adhering to the various components of the protocol. To assess feasibility, examine the following variables: drop-out rates; rates of adherence to diet and supplemental protocol; and rates of common side-effects. III. Assess whether the PSMF improves biomarkers of disease risk in this population. To assess whether this objective has been met, assess the following variables: blood lipids (total cholesterol, low density lipid [LDL] cholesterol, high density lipid [HDL] cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein, interleukin-6, tumor necrosis factor [TNF]-alpha, and leptin). IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss. OUTLINE: PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. The protein recommendation will be communicated to participants in terms of grams per day. Participants are encouraged to adhere as closely as possible to the protein recommendation. Based on the protein recommendation, participants are advised to consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that each ounce of these products contains seven grams of protein. Participants are provided with a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings of non-starchy vegetables per day. Participants remain on the PSMF until they have successfully reduced their initial body weight by 15% or up to 6 months. Participants are also provided with supplements to consume daily. WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight, participants are instructed by a RD to consume a weight maintenance diet or they may remain on the PSMF. The weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy vegetables is unlimited. Participants receive handouts that list common foods and the number of carbohydrates in each serving and educated on nutrition label reading for carbohydrates, with emphasis on serving size and total number of carbohydrates per serving. After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4, 5, and 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.