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

Obesity Clinical Trial

Official title:

Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03042897
• Other study ID #: 5U-16-1
• Secondary ID: NCI-2016-016845U
• Status: Withdrawn
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Estrogen Receptor Positive
• Obesity
• Progesterone Receptor Positive
• Stage I Uterine Corpus Cancer
• Stage IA Uterine Corpus Cancer
• Stage IB Uterine Corpus Cancer
• Weight Loss

Intervention

Dietary Supplement:
• Dietary Intervention
Undergo DASH diet

Behavioral:
• Exercise Intervention
Undergo in aerobic exercise

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 34 weeks
Primary	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.	Up to 34 weeks
Primary	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).	Up to 34 weeks
Primary	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).	Up to 34 weeks
Primary	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.	Up to 34 weeks
Primary	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.	At 16 weeks
Primary	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.	Up to 34 weeks