The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:July 24, 2018
End Date:October 24, 2021
Contact:Kathryn Pennington
Email:katypenn@uw.edu
Phone:206-598-8300

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The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors - A Randomized Controlled Trial

Many women with ovarian cancer experience distress, fatigue, weakness, anxiety, and other
symptoms that decrease quality of life. Moderate exercise may improve quality of life,
decrease distress, and improve biomarkers associated with prognosis in women with ovarian
cancer. This clinical trial studies how well moderate exercise works in improving distress,
quality of life, and biomarkers of angiogenesis and chronic stress in women with ovarian,
fallopian tube, and primary peritoneal cancer.


Inclusion Criteria:

- Histologically or cytologically confirmed stage II-IV epithelial ovarian, fallopian
tube, or peritoneal cancer. The following histologic epithelial cell types are
eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
clear cell carcinoma, mixed epithelial carcinoma, transitional cell carcinoma,
malignant Brenner's tumor, undifferentiated carcinoma, or adenocarcinoma not otherwise
specified. If site of origin cannot be specified, carcinoma of Mullerian origin may be
included if most consistent with ovarian/fallopian tube/primary peritoneal origin
rather than uterine origin. Women with neoplasms of low malignant potential
(borderline tumors) are not eligible.

- Subjects must have no evidence of disease, as defined by their treating oncologist,
and with normal CA-125 (=< 35).

- Subjects must have completed surgery and adjuvant chemotherapy for treatment of
ovarian cancer within one to six months of screening. Maintenance therapy will be
allowed as long as the participant is in clinical remission- including hormonal
agents, anti-angiogenesis agents, PARP inhibitors, and immunotherapy. Prior radiation
therapy is allowed, as long as it has been completed within one to six months of
screening. Subjects may have received prior therapies (including surgery,
chemotherapy, radiation therapy) for other malignancies in the past.

- Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.

- Pregnancy and the need for contraception:

* Participants with ovarian cancer have undergone hysterectomy with removal of ovaries
and tubes as part of surgical treatment, and therefore do not have the potential to
become pregnant.

- Ambulatory.

- Ability to understand and the willingness to sign a written informed consent document.

- Women participating in other clinical trials are eligible provided their enrollment in
the other trial does not impair their ability to participate in the physical activity
interventions and study assessments required in this trial. The other clinical trial
must not be a behavioral intervention trial.

Exclusion Criteria:

- Subjects who have had surgery, chemotherapy and/or radiation therapy within 4 weeks
prior to screening. Subjects may have received other surgeries not performed for
primary treatment (for example, removal of intraperitoneal port, laparoscopic
cholecystectomy, etc.) within 1 month of screening as long as they do not have
post-operative restrictions that would preclude participating in a moderate intensity
exercise program once enrolled in the clinical trial.

- Self-reported inability to walk at least 2 blocks (at any pace).

- Prior brain metastasis is not an exclusion, as long as subject is in clinical
remission.

- Uncontrolled or concurrent illness including, but not limited to: unstable angina
pectoris, recent (within six months) myocardial infarction, uncontrolled cardiac
arrhythmia, uncontrolled congestive heart failure, third degree heart block,
uncontrolled hypertension (systolic > 200, diastolic > 100), conditions
(cardiovascular, respiratory, or musculoskeletal disease or joint problems) that
preclude moderate physical activity. Subjects with a history of cardiac arrest or
stroke, or those with moderate/severe aortic stenosis may be eligible if their
treating physician determines that moderate physical activity is safe. Moderate
arthritis that does not preclude physical activity is not a reason for ineligibility.
Women with lymphedema or peripheral neuropathy will not be excluded. They will be
evaluated by the exercise physiologist for safety and modifications to the exercise
prescription will be made as appropriate.

- Psychiatric illness/social situations that would limit compliance with study
requirements.

- Already physically active > 90 minutes per week of moderate exercise.
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Kathryn Pennington, MD
?
mi
from
Seattle, WA
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