Clinical trial · Interventional
the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer
Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
NCT03908996CI-TRIAL-00050732completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Overweight | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Profile by Sanford weight management plan | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Profile by Sanford
- description
- All enrolled subjects are assigned to participate in the Profile by Sanford weight management program for a period of 12 months..Subjects will follow the Profile program and will be provided a nutritional plan which includes consuming Profile nutritional supplements and other food items. Subjects will work with a Profile lifestyle coach to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior. Subjects on this research study will follow the Profile by Sanford weight loss and management plan as all Profile members. All enrolled subjects will collect and return a fecal specimen prior to beginning the Profile by Sanford weight management plan and again after 6 months of participation.
- interventionNames
- Behavioral: Profile by Sanford weight management plan
Primary outcomes (2)
- measure
- Determine weight change from baseline to 6 months.
- timeFrame
- 6 months after starting weight management program
- description
- All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (9)
- BACKGROUNDHoedjes M, van Stralen MM, Joe STA, Rookus M, van Leeuwen F, Michie S, Seidell JC, Kampman E. Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature. J Cancer Surviv. 2017 Jun;11(3):360-385. doi: 10.1007/s11764-016-0594-8. Epub 2017 Jan 18. PMID 28097452
- BACKGROUNDLinkov F, Goughnour SL, Ma T, Xu Z, Edwards RP, Lokshin AE, Ramanathan RC, Hamad GG, McCloskey C, Bovbjerg DH. Changes in inflammatory endometrial cancer risk biomarkers in individuals undergoing surgical weight loss. Gynecol Oncol. 2017 Oct;147(1):133-138. doi: 10.1016/j.ygyno.2017.07.144. Epub 2017 Aug 7. PMID 28797697
- BACKGROUNDLuo J, Hendryx M, Chlebowski RT. Intentional weight loss and cancer risk. Oncotarget. 2017 Sep 6;8(47):81719-81720. doi: 10.18632/oncotarget.20671. eCollection 2017 Oct 10. No abstract available. PMID 29137210
- BACKGROUNDMassetti GM, Dietz WH, Richardson LC. Excessive Weight Gain, Obesity, and Cancer: Opportunities for Clinical Intervention. JAMA. 2017 Nov 28;318(20):1975-1976. doi: 10.1001/jama.2017.15519. No abstract available. PMID 28973170
- BACKGROUNDMcCarroll ML, Armbruster S, Frasure HE, Gothard MD, Gil KM, Kavanagh MB, Waggoner S, von Gruenigen VE. Self-efficacy, quality of life, and weight loss in overweight/obese endometrial cancer survivors (SUCCEED): a randomized controlled trial. Gynecol Oncol. 2014 Feb;132(2):397-402. doi: 10.1016/j.ygyno.2013.12.023. Epub 2013 Dec 22. PMID 24369301
- BACKGROUNDMcCarroll ML, Armbruster S, Pohle-Krauza RJ, Lyzen AM, Min S, Nash DW, Roulette GD, Andrews SJ, von Gruenigen VE. Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. Gynecol Oncol. 2015 Jun;137(3):508-15. doi: 10.1016/j.ygyno.2014.12.025. Epub 2015 Feb 11. PMID 25681782