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

Not Applicable

Withdrawn

• Conditions: Estrogen Receptor Positive; Progesterone Receptor Positive; Stage IB Uterine Corpus Cancer; Obesity; Stage I Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer
• Interventions: Dietary Supplement: Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

• Registration Number: NCT03042897
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Study Start: 2017-09-08
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (exercise and diet)	Dietary Intervention	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.
Supportive Care (exercise and diet)	Laboratory Biomarker Analysis	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.
Supportive Care (exercise and diet)	Exercise Intervention	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.
Supportive Care (exercise and diet)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory Fitness (CRF)	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.
Fatigue measured by the Brief Fatigue Inventory	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).
Percent weight loss at the completion of the intervention	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)	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.
Cardiovascular (CV) health outcomes	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	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	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States