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Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02135562
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Obesity Dietary Supplement: Dietary Intervention Other: Informational Material Other: Dietary Education Dietary Supplement: Weight Maintenance Other: Average score of Obesity and Weight-Loss Quality of Life Questionnaire Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors
Actual Study Start Date : August 8, 2014
Actual Primary Completion Date : April 19, 2017
Actual Study Completion Date : April 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (PSMF)
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 Supplement: Dietary Intervention
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.
Other Names:
  • Dietary Modification
  • intervention, dietary

Other: Informational Material
Receive carbohydrate reintroduction handout

Other: Dietary Education
Receive education on nutrition label reading for carbohydrates
Other Name: intervention, educational

Dietary Supplement: 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

Other: 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 Outcome Measures :
  1. Mean Weight loss assessed with the digital scale [ Time Frame: Baseline up to 6 months ]
    Mean weight loss will be presented as mean total weight loss in kilograms from baseline

  2. Mean Weight loss assessed with the digital scale [ Time Frame: Baseline up to 12 months ]
    Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.


Secondary Outcome Measures :
  1. Changes in levels of total cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences in total cholesterol between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  2. Changes in levels of markers of inflammation (C-reactive protein) [ Time Frame: Up to 6 months ]
    Average differences in C-reactive protein between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  3. Changes in levels of glucose [ Time Frame: Up to 6 months ]
    Differences in glucose levels between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  4. Number of drop-out participants [ Time Frame: Up to 6 months ]
    Presented as the difference in the number of participants who completed the study from the number of participants enrolled at baseline. This is reported as one of the markers of feasibility.

  5. Average percentage of positive urinary ketone tests as a marker of dietary adherence [ Time Frame: Up to 6 months ]
    Assessed using the presence of urinary ketones beginning on day four of the intervention. Adherence rates will be presented as the percentage of positive urinary ketone tests for the duration of the intervention.

  6. Number of Participant with reported side effects [ Time Frame: Up to 6 months ]
    Adverse events will be recorded by participants on a daily basis. Number of participants with related adverse events will be reported as one of the measures of feasibility

  7. Changes in quality-of-life as assessed by the Obesity and Weight Loss Quality-of-Life Questionnaire [ Time Frame: Baseline up to 6 months ]
    The difference between mean quality of life scores at the two time points will be assessed using a one-sided anova test with statistical significance set at p < 0.05.

  8. Changes in levels of markers of inflammation (interleukin 6) [ Time Frame: Up to 6 months ]
    Average differences in interleukin 6 between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  9. Changes in levels of markers of inflammation (tumor necrosis factor - alpha) [ Time Frame: Up to 6 months ]
    Average differences in tumor necrosis factor - alpha between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  10. Changes in levels of markers of inflammation (leptin) [ Time Frame: Up to 6 months ]
    Average differences of leptin between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  11. Changes in levels of LDL-cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for LDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  12. Changes in levels of HDL-cholesterol [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for HDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.

  13. Changes in levels of triglycerides [ Time Frame: Baseline up to 6 months ]
    Average differences between time points for triglycerides will be assessed using a one-sided anova test with statistical significance defined as having a p-value < 0.05.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135562


Locations
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United States, Ohio
Cleveland Medical Center, University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kimberly Resnick Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02135562    
Other Study ID Numbers: CASE1814
NCI-2014-00832 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE1814
CASE 1814 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
endometrial cancer
survivor
obesity
diet
high protein
protein-sparing modified fast intervention
PSMF
Additional relevant MeSH terms:
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Endometrial Neoplasms
Weight Loss
Body Weight
Body Weight Changes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases