the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer
Completed · Not applicable
Conditions studied: Endometrial Cancer, Overweight
In brief
The primary purpose of this study is to evaluate the effectiveness of a 12-month comprehensive weight management program on weight change in overweight/obese patients following treatment for endometrial cancer. During the study period, subjects will be monitored for recurrence during routine clinic visits A secondary exploratory purpose of this study will be to evaluate the gut microbiome in this intervention group and the changes that may occur while participating in a weight loss and weight management program.
Key facts
- Study ID
- NCT03908996
- Run by
- Sanford Health
- People needed
- 25
- Starts
- 2019-02-11
- Expected to finish
- 2021-01-11
- Last updated by the study team
- 2021-03-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 18 years of age and older with a diagnosis of endometrial cancer
- No known metastatic disease
- Has completed all treatment for their endometrial cancer at least 2 months prior to enrollment.
- Has a BMI (Body Mass Index) of 30 or higher
- Ability to understand the purpose of study and willingness to sign consent
- Willingness to collect fecal specimens at the required time points
- Capable of following the dietary guidelines and instructions for the Profile weight management plan
- Agrees to sharing information between Profile and Sanford Research study personnel
You may not qualify if…
- BMI (Body Mass Index) less than 30
- Known metastatic disease
- Receiving treatment or expected to receive treatment for endometrial cancer or any other cancer
- Any psychological, familial, sociological conditions that the physician feels will interfere with medical follow-up and compliance on the study
- Taking insulin for diabetes (oral medications for diabetes allowed)
- Use of corticosteroids for a chronic medical condition
- Known liver disease
- Bowel or stomach disorders that the physician feels would interfere with Profile participation.
- Any history of malabsorption syndrome or substantial amounts of small bowel or stomach surgery that impairs nutrient absorption
Where it is running
- Roger Maris Cancer Center — Fargo, North Dakota, United States
- Sanford Gynecological Oncology clinic — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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