Clinical trial NCT03908996: the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer
Official title: Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Overweight
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled patients will participate in the Profile weight management program
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: All enrolled subjects will participate in the Profile weight loss and weight management program for a period of 12 months. They will work with a Profile lifestyle coach weekly to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior as done with all Profile members. A comparison of similar retrospective chart reviews based on age, weight in pounds and stage of cancer will be conducted using the Electronic Medical Record (EMR). All enrolled subjects will collect and return a fecal specimen prior to beginning the weight management plan and again after 6 months of participation. The stool sample will be used to understand gut health.

Eligibility criteria: 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

Primary outcomes:
measure: Determine weight change from baseline to 6 months.
timeFrame: 6 months after starting weight management program
measure: Determine weight change from baseline to 12 months.
timeFrame: 12 months after starting weight management program
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Roger Maris Cancer Center
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Gynecological Oncology clinic
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Maria Bell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoedjes 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.
citation: Linkov 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.
citation: Luo 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.
citation: Massetti 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.
citation: McCarroll 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.
citation: McCarroll 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.
citation: Steele CB, Thomas CC, Henley SJ, Massetti GM, Galuska DA, Agurs-Collins T, Puckett M, Richardson LC. Vital Signs: Trends in Incidence of Cancers Associated with Overweight and Obesity - United States, 2005-2014. MMWR Morb Mortal Wkly Rep. 2017 Oct 3;66(39):1052-1058. doi: 10.15585/mmwr.mm6639e1.
citation: Yu J, Feng Q, Wong SH, Zhang D, Liang QY, Qin Y, Tang L, Zhao H, Stenvang J, Li Y, Wang X, Xu X, Chen N, Wu WK, Al-Aama J, Nielsen HJ, Kiilerich P, Jensen BA, Yau TO, Lan Z, Jia H, Li J, Xiao L, Lam TY, Ng SC, Cheng AS, Wong VW, Chan FK, Xu X, Yang H, Madsen L, Datz C, Tilg H, Wang J, Brunner N, Kristiansen K, Arumugam M, Sung JJ, Wang J. Metagenomic analysis of faecal microbiome as a tool towards targeted non-invasive biomarkers for colorectal cancer. Gut. 2017 Jan;66(1):70-78. doi: 10.1136/gutjnl-2015-309800. Epub 2015 Sep 25.
citation: Zitvogel L, Ma Y, Raoult D, Kroemer G, Gajewski TF. The microbiome in cancer immunotherapy: Diagnostic tools and therapeutic strategies. Science. 2018 Mar 23;359(6382):1366-1370. doi: 10.1126/science.aar6918.