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Assisted Exercise in Obese Endometrial Cancer Patients

NCT01870947CompletedNAINTERVENTIONAL

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, 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.

Key Facts

Lead Sponsor

Case Comprehensive Cancer Center

Enrollment

Start Date

2011-09-07

Completion Date

2019-09-04

Study Type

INTERVENTIONAL

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

Interventions

Exercise on stationary recumbent exercise cycleHealth EducationQuestionnairesNeuroimagingGenetic and Biomarkers

Conditions

Stage I Endometrial AdenocarcinomaUterine CancerObesity

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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

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 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

Outcome Measures

Primary Outcomes

Weight change from pre- to post-intervention

Time frame: 24 weeks after exercise intervention (EOT)

Secondary Outcomes

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)

Time frame: at 4 weeks after exercise intervention(EOT)

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.

Time frame: 24 weeks after exercise intervention (EOT)

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.

Time frame: 24 weeks after exercise intervention (EOT)

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.

Time frame: 24 weeks after exercise intervention (EOT)

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).

Time frame: 24 weeks after exercise intervention (EOT)

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.

Time frame: 24 weeks after exercise intervention (EOT)

Locations

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, United States

The Cleveland Clinic Foundation, Cleveland, United States

Linked Papers

2019-09-02

Sleep, quality of life, and depression in endometrial cancer survivors with obesity seeking weight loss

Incidence and mortality rates of uterine cancer are increasing and, obesity, which is also rising, has been associated with uterine cancer development and mortality. A recent study found that poor sleep quality is common among endometrial cancer survivors and those with obesity had more sleep disturbances than those having normal weight. However, it is unclear if higher levels of obesity (Class III, BMI ≥ 40 kg/m We evaluated sleep, depression, and quality of life in 100 Stage I endometrial cancer survivors with obesity seeking weight loss enrolled in a lifestyle intervention (NCT01870947) at baseline. The average age was 60 years and mean BMI was 42.1 kg/m Our results reveal that endometrial cancer survivors with class III compared with class I obesity have poorer sleep quality, higher depression, and lower quality of life. Given the rising rates of obesity and uterine cancer mortality, interventions to combat both obesity and poor sleep are needed.

Linked Investigators

Nora L. Nock