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Stage I Endometrial AdenocarcinomaNCT01870947

Assisted Exercise in Obese Endometrial Cancer Patients

A study testing Exercise on stationary recumbent exercise cycle, Health Education and Questionnaires in people with Stage I Endometrial Adenocarcinoma and Uterine Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Exercise on stationary recumbent exercise cycle, Health Education and Questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
2 sitesUnited States
Study dates
7 Sep 2011to 4 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 4 years after completion of treatment.
  • BMI ≥ 30.0 (obese)
  • Approved to be contacted by the patient's treating gynecologic oncologist
  • Meets screening criteria including successful completion of a cardiopulmonary stress test
  • Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study

Who cannot join

  • Individuals unable to read and provide informed consent.
  • Women currently participating in a structured weight loss or exercise program in the past 6 months or any woman who has previously had bariatric surgery or is planning to undergo bariatric surgery in the next 12 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients

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.

Read the 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 12 and 24 weeks post-EOT, in obese EC patients who will be randomized to perform 'assisted' or voluntary exercise.

Secondary Objectives:

Objective 1: To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go signaling (SST) in fed 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 12 and 24 weeks post-intervention in obese EC patients performing 'assisted' and voluntary exercise.

Objective 2: To examine the modification of the neuronal response to high vs. low calorie food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating homeostatic and non-homeostatic energy systems.

Patients will be randomized to receive either the assisted exercise (n=60) or voluntary exercise (n=60) 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.

Being tested
Exercise on stationary recumbent exercise cycle, Health Education, Questionnaires, Neuroimaging, Genetic and Biomarkers
Keywords
Stage I endometrial adenocarcinoma, Obesity, Exercise and Physical Fitness, Diet, Cancer
Medical subject headings
Uterine Neoplasms, Obesity, Motor Activity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise on stationary recumbent exercise cycleBehavioural

  • Health EducationBehavioural

    Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)

  • QuestionnairesBehavioural

    Also called Exercise Motivations Inventory (EMI-2), Intrinsic Motivational Inventory (IMI), Three-Factor Eating Questionnaire (TFEQ), Functional Assessment of Cancer Therapy - General (FACT-G)

  • NeuroimagingProcedure or surgery

    Also called MRI

    Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.

  • Genetic and BiomarkersProcedure or surgery

    Also called DNA Testing, Biomarker Testing

    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).

Study groups in NCT01870947
Study groupRoleWhat they receive
'Assisted-Rate' Exercise InterventionExperimentalSubjects 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.
Receives: Behavioral: Exercise on stationary recumbent exercise cycle; Behavioral: Health Education; Behavioral: Questionnaires; Procedure: Neuroimaging; Procedure: Genetic and Biomarkers
'Voluntary-Rate' Exercise InterventionExperimentalSubjects 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.
Receives: Behavioral: Exercise on stationary recumbent exercise cycle; Behavioral: Health Education; Behavioral: Questionnaires; Procedure: Neuroimaging; Procedure: Genetic and Biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight change from pre- to post-intervention

    Measured: 24 weeks after exercise intervention (EOT)

Secondary outcomes (6)

  1. Change in Body Composition from baseline

    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)

    Measured: at 4 weeks after exercise intervention(EOT)

  2. Change in Motivation to Exercise from baseline

    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.

    Measured: 24 weeks after exercise intervention (EOT)

  3. Change in Eating Behavior from baseline

    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.

    Measured: 24 weeks after exercise intervention (EOT)

  4. Change in Quality of Life (QoL)from baseline

    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.

    Measured: 24 weeks after exercise intervention (EOT)

  5. Change in Depression from baseline

    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).

    Measured: 24 weeks after exercise intervention (EOT)

  6. Exercise Session Adherence

    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.

    Measured: 24 weeks after exercise intervention (EOT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study start7 Sep 2011
  3. Primary completion4 Sep 2019
  4. Study completion4 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01870947
Sponsor's protocol ID
CASE5811
Status last verified
Jan 2020
First submitted
4 Jun 2013
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nock NL, Dimitropoulos A, Zanotti KM, Waggoner S, Nagel C, Golubic M, Michener CM, Kirwan JP, Alberts J. Sleep, quality of life, and depression in endometrial cancer survivors with obesity seeking weight loss. Support Care Cancer. 2020 May;28(5):2311-2319. doi: 10.1007/s00520-019-05051-1. Epub 2019 Sep 2.

    PubMed 31478164

Questions about this trial

What is this clinical trial studying?

A study testing Exercise on stationary recumbent exercise cycle, Health Education and Questionnaires in people with Stage I Endometrial Adenocarcinoma and Uterine Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change from pre- to post-intervention (time frame: 24 weeks after exercise intervention (EOT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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