Assisted Exercise in Obese Endometrial Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Case Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01870947
First received: June 4, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.


Condition Intervention
Stage I Endometrial Adenocarcinoma
Uterine Cancer
Obesity
Behavioral: Exercise on stationary recumbent exercise cycle
Behavioral: Health Education
Behavioral: Questionnaires
Procedure: Neuroimaging
Procedure: Genetic and Biomarkers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Pilot Study of Assisted Exercise in Obese Endometrial Cancer Patients

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Weight change from pre- to post-intervention [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Body Composition from baseline [ Time Frame: at 4 weeks after exercise intervention(EOT) ] [ Designated as safety issue: No ]
    Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: < 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight)

  • Change in Motivation to Exercise from baseline [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]
    Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire.

  • Change in Eating Behavior from baseline [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]
    Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger.

  • Change in Quality of Life (QoL)from baseline [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]
    The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures.

  • Change in Depression from baseline [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms).

  • Exercise Session Adherence [ Time Frame: 24 weeks after exercise intervention (EOT) ] [ Designated as safety issue: No ]
    Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program.


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 'Assisted-Rate' Exercise Intervention
Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.
Behavioral: Exercise on stationary recumbent exercise cycle Behavioral: Health Education
Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)
Behavioral: Questionnaires
Other Names:
  • Exercise Motivations Inventory (EMI-2)
  • Intrinsic Motivational Inventory (IMI)
  • Three-Factor Eating Questionnaire (TFEQ)
  • Functional Assessment of Cancer Therapy - General (FACT-G)
  • FACT-En
  • Short-form Medical Outcomes (SF-36)
  • Beck Depression Inventory (BDI)
  • Godin Leisure-Time Exercise (LSI)
Procedure: Neuroimaging
Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
Other Name: MRI
Procedure: Genetic and Biomarkers
Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).
Other Names:
  • DNA Testing
  • Biomarker Testing
Experimental: 'Voluntary-Rate' Exercise Intervention
Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.
Behavioral: Exercise on stationary recumbent exercise cycle Behavioral: Health Education
Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)
Behavioral: Questionnaires
Other Names:
  • Exercise Motivations Inventory (EMI-2)
  • Intrinsic Motivational Inventory (IMI)
  • Three-Factor Eating Questionnaire (TFEQ)
  • Functional Assessment of Cancer Therapy - General (FACT-G)
  • FACT-En
  • Short-form Medical Outcomes (SF-36)
  • Beck Depression Inventory (BDI)
  • Godin Leisure-Time Exercise (LSI)
Procedure: Neuroimaging
Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
Other Name: MRI
Procedure: Genetic and Biomarkers
Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).
Other Names:
  • DNA Testing
  • Biomarker Testing
Control
No exercise/educational information only control group
Behavioral: Health Education
Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)
Behavioral: Questionnaires
Other Names:
  • Exercise Motivations Inventory (EMI-2)
  • Intrinsic Motivational Inventory (IMI)
  • Three-Factor Eating Questionnaire (TFEQ)
  • Functional Assessment of Cancer Therapy - General (FACT-G)
  • FACT-En
  • Short-form Medical Outcomes (SF-36)
  • Beck Depression Inventory (BDI)
  • Godin Leisure-Time Exercise (LSI)
Procedure: Neuroimaging
Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
Other Name: MRI
Procedure: Genetic and Biomarkers
Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).
Other Names:
  • DNA Testing
  • Biomarker Testing

Detailed Description:

Primary Objective:

To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT)and 4 weeks post-EOT in obese EC patients who will be randomized to perform 'assisted', voluntary or no exercise (healthy living educational information only).

Secondary Objective:

To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 4 weeks post-intervention (EOT+4) in obese EC patients performing 'assisted', voluntary or no exercise (healthy living educational information only).

Patients will be randomized to receive either the assisted exercise (n=10), voluntary exercise (n=10) or no exercise (n=6) group. Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks. The control group will be asked to complete all exercise, body composition and fMRI testing similar to the exercise groups. Patients in the No Exercise/Educational Information Only control group will complete the same set of questionnaires as the patients in the exercise groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years) women of all races
  • Histologically confirmed Stage I ) endometrial adenocarcinoma (EC), grade 1 or 2, with no adjuvant chemotherapy. Patients will be eligible to enroll as soon as 3 months after completion of treatment but no later than 2 years after completion of treatment.
  • BMI ≥ 30.0 (obese)
  • Approved to be contacted by the patient's treating gynecologic oncologist
  • Meets screening criteria (discussed in Section 3.4 below)
  • Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study

Exclusion Criteria:

  • Individuals unable to read and provide informed consent.
  • Women currently participating in a structured weight loss or exercise program in the past 6 months
  • Participants who do not consent to be in the study or who will be unavailable for follow-up assessments,
  • Pre-existing medical conditions that would be a barrier for participation in supervised exercise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870947

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nora Nock, PhD    216-368-5653    nora.nock@case.edu   
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jay Alberts, PhD    216-445-3222    albertj@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Nora Nock, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01870947     History of Changes
Other Study ID Numbers: CASE5811
Study First Received: June 4, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
Stage I endometrial adenocarcinoma
Obesity
Exercise and Physical Fitness
Diet
Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Endometrial Neoplasms
Obesity
Uterine Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014