TerminatedNCT03641287Updated Nov 29, 2023Results posted

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

An interventional study of Exercise Counseling and Aerobic Exercise in Ovarian Cancer, Fallopian Tube Adenocarcinoma and Fallopian Tube Carcinosarcoma, sponsored by University of Washington. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Washington · Not applicable, Interventional, and Supportive care

Why this study was terminated

Enrollment ended early due to the funding timeline

Phase: Not applicable
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Read the detailed 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.

Conditions studied

Ovarian Cancer
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
Ovarian Adenocarcinoma
Ovarian Carcinosarcoma
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Ovarian Undifferentiated Carcinoma
Primary Peritoneal Serous Adenocarcinoma
Primary Peritoneal Carcinosarcoma
Primary Peritoneal Transitional Cell Carcinoma

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 64 participants (actual)

Study arms

Experimental
Arm I (aerobic exercise)
Participants meet with exercise physiologist for 1, 60 minute session. Participants then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Participants also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks.
Other: Exercise Counseling · Other: Aerobic Exercise · Other: Physiological Support · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Active comparator
Arm II (habitual level of physical activity)
Participants maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, participants are offered exercise intervention.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Other: Best Practice

Interventions

OtherExercise Counseling
Meet with exercise physiology
OtherAerobic Exercise
Receive prescription for moderate aerobic exercise
Also known as: Aerobic Activity, aerobic exercise
OtherPhysiological Support
Receive motivational support via telephone care
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies
OtherBest Practice
Undergo habitual level of physical activity
Also known as: best practice, standard of care, standard of care, standard therapy

What researchers measure

Primary outcomes

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.
Time frame: Baseline up to 24 weeks
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.
Time frame: Baseline to 24 weeks
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.
Time frame: Baseline to 24 weeks
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.
Time frame: Baseline to 24 weeks
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.
Time frame: Baseline to 24 weeks
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.
Time frame: Baseline to 24 weeks
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.
Time frame: Baseline to 24 weeks

Results

Posted Nov 29, 2023

Limitations and caveats

Enrollment ended before meeting accrual goal due to the funding timeline, leading to smaller numbers of participants analyzed. Most participants completed the study after the COVID-19 pandemic began. The study continued for several years during the pandemic. Multiple surges occurred and there was variable timing of infections experienced by participants and their loved ones over the course of their 6 month study participation. Participants were not uniformly affected by the COVID-19 pandemic.

Participant flow

Participant flow — Overall Study
Milestone	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Started	31	33
Completed	28	33
Not completed	3	0

Outcome measures

PrimaryChange 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.

Time frame:: Baseline up to 24 weeks
Reported as:: Mean · score on a scale

Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score
score on a scale	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score	4.37 ± 0.99	4.61 ± 2.02

PrimaryChange 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.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · score on a scale

Change in Distress, Measured Using the Perceived Stress Scale
score on a scale	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in Distress, Measured Using the Perceived Stress Scale	-1.4 ± 0.97	1.05 ± 1.64

PrimaryChange 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.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · score on a scale

Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale
score on a scale	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale	-1.15 ± 0.56	-0.15 ± 0.72

PrimaryChange 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.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · score on a scale

Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale
score on a scale	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale	-0.76 ± 0.42	-0.32 ± 0.80

PrimaryChange 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.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · pg/mL

Change in IL-6 (Biomarker of Angiogenesis)
pg/mL	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in IL-6 (Biomarker of Angiogenesis)	-0.57 ± 2.03	0.09 ± 0.54

PrimaryChange in VEGF (Biomarker of Angiogenesis)

Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · pg/mL

Change in VEGF (Biomarker of Angiogenesis)
pg/mL	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in VEGF (Biomarker of Angiogenesis)	-37.3 ± 41.84	-82.2 ± 36.35

PrimaryChange 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.

Time frame:: Baseline to 24 weeks
Reported as:: Mean · ug/dL

Change in Nocturnal Cortisol (Biomarker of Chronic Stress)
ug/dL	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)
Change in Nocturnal Cortisol (Biomarker of Chronic Stress)	0.01 ± 0.157	0.11 ± 0.07

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm I (Aerobic Exercise)	0/31 (0%)	0/31 (0%)	0/31 (0%)
Arm II (Habitual Level of Physical Activity)	0/33 (0%)	0/33 (0%)	0/33 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
<=18 years	0	0	0
Between 18 and 65 years	15	15	30
>=65 years	16	18	34

Age, Continuous
Age, Continuous(years)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
Mean	61.77 ± 9.68	63.73 ± 10.69	62.78 ± 10.18

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
Female	31	33	64
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
Hispanic or Latino	4	2	6
Not Hispanic or Latino	27	31	58
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
American Indian or Alaska Native	1	0	1
Asian	1	4	5
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	1	1	2
White	28	26	54
More than one race	0	1	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
United States	31	33	64

Body Mass Index
Body Mass Index(kg/m^2)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
Mean	26.73 ± 5.31	28.92 ± 7.17	27.86 ± 6.39

Stage
Stage(Participants)	Arm I (Aerobic Exercise)	Arm II (Habitual Level of Physical Activity)	Total
Stage II	3	4	7
Stage III	22	17	39
Stage IV	6	12	18

Study locations

1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109, United States

References and documents

Study documents

Protocol and statistical analysis plan · Sep 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03641287
Lead sponsor: University of Washington
Collaborators: National Cancer Institute (NCI)
Responsible party: Kathryn Pennington (Assistant Professor, University of Washington) — Principal investigator
First posted: Aug 22, 2018
Start date: Dec 5, 2018
Primary completion: Sep 30, 2022
Completion: Sep 30, 2022
Results posted: Nov 29, 2023
Last update: Nov 29, 2023

Study contacts

Kathryn Pennington

principal investigator · University of Washington

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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