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Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

Primary Purpose

Estrogen Receptor Positive, Obesity, Progesterone Receptor Positive

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Exercise Intervention
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Estrogen Receptor Positive

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (exercise and diet)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2017
Last Updated
December 15, 2020
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03042897
Brief Title
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Official Title
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength. TERTIARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor Positive, Obesity, Progesterone Receptor Positive, Stage I Uterine Corpus Cancer, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (exercise and diet)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Undergo DASH diet
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo in aerobic exercise
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness (CRF)
Description
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.
Time Frame
Up to 34 weeks
Title
Cardiovascular (CV) health outcomes
Description
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.
Time Frame
Up to 34 weeks
Title
Depression measured by Center for Epidemiologic Studies Depression scale
Description
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).
Time Frame
Up to 34 weeks
Title
Fatigue measured by the Brief Fatigue Inventory
Description
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).
Time Frame
Up to 34 weeks
Title
Muscle strength
Description
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.
Time Frame
Up to 34 weeks
Title
Percent weight loss at the completion of the intervention
Description
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.
Time Frame
At 16 weeks
Title
Quality of Life (QOL)
Description
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.
Time Frame
Up to 34 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

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