Endometrial CancerNCT03908996
the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer
A study testing Profile by Sanford weight management plan in people with Endometrial Cancer and Overweight, run by Sanford Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Overweight
- What is being tested?
- Profile by Sanford weight management plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2019to 11 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roger Maris Cancer Center
Fargo, North Dakota, 58102
Sanford Gynecological Oncology clinic
Sioux Falls, South Dakota, 57104
About this study
Official title: Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
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.
Read the 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.
- Conditions
- Endometrial Cancer, Overweight
- Being tested
- Profile by Sanford weight management plan
- Medical subject headings
- Endometrial Neoplasms, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profile by Sanford weight management planBehavioural
The purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program.
| Study group | Role | What they receive |
|---|---|---|
| Profile by Sanford | Experimental | 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. Receives: Behavioral: Profile by Sanford weight management plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine weight change from baseline to 6 months.
All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded.
Measured: 6 months after starting weight management program
Determine weight change from baseline to 12 months.
All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded.
Measured: 12 months after starting weight management program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start11 Feb 2019
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled patients will participate in the Profile weight management program
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Bell, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908996
- Sponsor's protocol ID
- SH Profile II
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28097452Linkov 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.
PubMed 28797697Luo 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.
PubMed 29137210Massetti 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.
PubMed 28973170McCarroll 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.
PubMed 24369301McCarroll 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.
PubMed 25681782Steele 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.
PubMed 28981482Yu 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.
PubMed 26408641Zitvogel 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.
PubMed 29567708
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
- ClinicalTrials.gov ID
- NCT03908996
- Acronym / sponsor ID
- SH Profile II
- Conditions
- Endometrial Cancer, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients will participate in the Profile weight management program
| Arm | Type | Receives |
|---|---|---|
| Profile by Sanford | Experimental | Behavioral: Profile by Sanford weight management planAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profile by Sanford weight management planThe purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program. | Behavioural | Profile by Sanford |
Primary outcome
Determine weight change from baseline to 6 months.
Time frame: 6 months after starting weight management program
All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded.
Determine weight change from baseline to 12 months.
Time frame: 12 months after starting weight management program
All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 28097452Hoedjes 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.
- Background: PubMed 28797697Linkov 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.
- Background: PubMed 29137210Luo 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.
- Background: PubMed 28973170Massetti 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.
- Background: PubMed 24369301McCarroll 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.
- Background: PubMed 25681782McCarroll 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.
- Background: PubMed 28981482Steele 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.
- Background: PubMed 26408641Yu 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.
- Background: PubMed 29567708Zitvogel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Bell, MD principal investigator
Sanford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profile by Sanford weight management plan in people with Endometrial Cancer and Overweight, run by Sanford Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine weight change from baseline to 6 months. (time frame: 6 months after starting weight management program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908996, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.