Estrogen Receptor PositiveNCT03042897
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
A study testing Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis in people with Estrogen Receptor Positive and Obesity, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Estrogen Receptor Positive, Obesity, Progesterone Receptor Positive
- What is being tested?
- Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 31 Jul 2019
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
- Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
- Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
- Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Who cannot join
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
- In judgement of a physician, is not a candidate for progestin agents
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
- Conditions
- Estrogen Receptor Positive, Obesity, Progesterone Receptor Positive, Stage I Uterine Corpus Cancer, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer
- Being tested
- Dietary Intervention, Exercise Intervention, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Undergo DASH diet
Exercise InterventionBehavioural
Undergo in aerobic exercise
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (exercise and diet) | Experimental | Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks. Receives: Dietary Supplement: Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness (CRF)
Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
Measured: Up to 34 weeks
Cardiovascular (CV) health outcomes
Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
Measured: Up to 34 weeks
Depression measured by Center for Epidemiologic Studies Depression scale
Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
Measured: Up to 34 weeks
Fatigue measured by the Brief Fatigue Inventory
Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
Measured: Up to 34 weeks
Muscle strength
The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
Measured: Up to 34 weeks
Percent weight loss at the completion of the intervention
Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
Measured: At 16 weeks
Quality of Life (QOL)
The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
Measured: Up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start8 Sep 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor PositiveStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Dieli-Conwright, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042897
- Sponsor's protocol ID
- 5U-16-1
- Other IDs
- NCI-2016-01684, 5U-16-1, P30CA014089
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
- ClinicalTrials.gov ID
- NCT03042897
- Acronym / sponsor ID
- 5U-16-1
- Conditions
- Estrogen Receptor Positive, Obesity, Progesterone Receptor Positive, Stage I Uterine Corpus Cancer, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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.
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
- To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (exercise and diet) | Experimental | Dietary Supplement: Dietary Intervention, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life AssessmentPatients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
Key exclusion criteria (6 listed)
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
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 |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsUndergo DASH diet | Dietary supplement | Supportive Care (exercise and diet) |
| Exercise InterventionUndergo in aerobic exercise | Behavioural | Supportive Care (exercise and diet) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (exercise and diet) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (exercise and diet) |
Primary outcome
Cardiorespiratory Fitness (CRF)
Time frame: Up to 34 weeks
Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
Cardiovascular (CV) health outcomes
Time frame: Up to 34 weeks
Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
Depression measured by Center for Epidemiologic Studies Depression scale
Time frame: Up to 34 weeks
Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
Fatigue measured by the Brief Fatigue Inventory
Time frame: Up to 34 weeks
Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
Muscle strength
Time frame: Up to 34 weeks
The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
Percent weight loss at the completion of the intervention
Time frame: At 16 weeks
Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
Quality of Life (QOL)
Time frame: Up to 34 weeks
The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
Christina Dieli-Conwright, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis in people with Estrogen Receptor Positive and Obesity, run by University of Southern California at 1 site 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 6 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: withdrawn, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Cardiorespiratory Fitness (CRF) (time frame: Up to 34 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.