The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03641287
• Other study ID #: RG1001826
• Secondary ID: 10045NCI-2018-01
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many individuals 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 individuals 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 individuals with ovarian, fallopian tube, and primary peritoneal cancer.

Description:

OUTLINE:

Patients are randomized to 1 of 2 arms.

ARM I (EXERCISE INTERVENTION): Patients meet with exercise physiologist for 1, 60 minute session. Patients then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Patients also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks.

ARM II (CONTROL GROUP): Patients maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, patients are offered exercise intervention.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed stage II-IV epithelial ovarian, fallopian tube, or peritoneal cancer. If site of origin cannot be specified, carcinoma of Mullerian origin may be included if most consistent with ovarian/fallopian tube/peritoneal origin rather than uterine origin. 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, carcinosarcoma, or adenocarcinoma not otherwise specified. 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 primary surgery and adjuvant chemotherapy for treatment of ovarian, fallopian tube, of peritoneal 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.

• Individuals participating in most 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 primary 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, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (systolic > 200, diastolic > 120), conditions (cardiovascular, respiratory, or musculoskeletal disease or joint problems) that preclude moderate physical activity. Subjects with a history of cardiac arrest, or those with moderate/severe aortic or mitral 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. Individuals 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Brenner Tumor
• Carcinoma
• Carcinoma, Endometrioid
• Carcinoma, Ovarian Epithelial
• Carcinoma, Transitional Cell
• Carcinosarcoma
• Cystadenocarcinoma
• Fallopian Tube Adenocarcinoma
• Fallopian Tube Carcinosarcoma
• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube Mucinous Adenocarcinoma
• Fallopian Tube Serous Adenocarcinoma
• Fallopian Tube Transitional Cell Carcinoma
• Fallopian Tube Undifferentiated Carcinoma
• Malignant Ovarian Brenner Tumor
• Mixed Tumor, Mullerian
• Ovarian Adenocarcinoma
• Ovarian Cancer
• Ovarian Carcinosarcoma
• Ovarian Clear Cell Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Mucinous Adenocarcinoma
• Ovarian Neoplasms
• Ovarian Seromucinous Carcinoma
• Ovarian Serous Adenocarcinoma
• Ovarian Transitional Cell Carcinoma
• Ovarian Undifferentiated Carcinoma
• Primary Peritoneal Carcinosarcoma
• Primary Peritoneal Serous Adenocarcinoma
• Primary Peritoneal Transitional Cell Carcinoma

Intervention

Other:
• Exercise Counseling
Meet with exercise physiology
• Aerobic Exercise
Receive prescription for moderate aerobic exercise
• Physiological Support
Receive motivational support via telephone care
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Best Practice
Undergo habitual level of physical activity

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score	Will be measured using the RAND 36-item Short Form Health Survey Physical Component Score. Mean change from baseline to 24 weeks between the exercise intervention and control group in the RAND 36-item Short Form Health Survey Physical Component Score.; RAND 36-Item Short Form assesses eight subscales including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health. Possible scores for each subscale range from 0 to 100. The Physical Component Score (PCS) is an aggregate of the eight subscales using a standardized algorithm, with a mean of 50 and standard deviation of 10 in the general US population. Possible scores range from 20 to 60, with higher scores indicating a better quality of life.	Baseline up to 24 weeks
Primary	Change in Distress, Measured Using the Perceived Stress Scale	Will be measured using the Perceived Stress Scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Perceived Stress Scale.; The Perceived Stress Scale is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher distress.	Baseline to 24 weeks
Primary	Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale	Will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - anxiety subscale.; The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.; The Hospital Anxiety and Depression Scale - anxiety subscale total scores range from 0 to 21; higher scores indicated greater severity of anxiety symptoms.	Baseline to 24 weeks
Primary	Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale	Will be measured using the Hospital Anxiety and Depression Scale - Depression sub scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - Depression subscale.; The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.; The Hospital Anxiety and Depression Scale - Depression subscale total scores range from 0 to 21; higher scores indicated greater severity of depression symptoms.	Baseline to 24 weeks
Primary	Change in IL-6 (Biomarker of Angiogenesis)	Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6.	Baseline to 24 weeks
Primary	Change in VEGF (Biomarker of Angiogenesis)	Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.	Baseline to 24 weeks
Primary	Change in Nocturnal Cortisol (Biomarker of Chronic Stress)	Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.	Baseline to 24 weeks