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

NCT03042897 | Withdrawn DMC

• 3 other identifiers: 5U-16-1NCI-2016-01684P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Estrogen Receptor Positive; Obesity; Progesterone Receptor Positive; Stage I Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Dietary Supplement: Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Dietary Intervention DIETARY_SUPPLEMENT

Undergo DASH diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive Care (exercise and diet)

Exercise Intervention BEHAVIORAL

Undergo in aerobic exercise

Supportive Care (exercise and diet)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive Care (exercise and diet)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (exercise and diet)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Christina Dieli-Conwright, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: September 8, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)