CLINICAL TRIAL

Aerobic Exercise for Ovary Cancer

Stage II
Waitlist Available · 18+ · Female · Seattle, WA

This study is evaluating whether moderate exercise may improve quality of life, decrease distress, and improve biomarkers associated with prognosis in individuals with ovarian cancer.

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About the trial for Ovary Cancer

Eligible Conditions
Fallopian Tube Mucinous Adenocarcinoma · Ovarian Seromucinous Carcinoma · Brenner Tumor · Ovarian Endometrioid Adenocarcinoma · Malignant Ovarian Brenner Tumor · Adenocarcinoma of the Ovaries · Fallopian Tube Clear Cell Adenocarcinoma · Fallopian Tube Carcinosarcoma · Ovarian Mucinous Adenocarcinoma · Carcinoma, Endometrioid · Undifferentiated Fallopian Tube Carcinoma · Primary Peritoneal Serous Adenocarcinoma · Adenocarcinoma · Ovarian Clear Cell Adenocarcinoma · Primary Peritoneal Carcinosarcoma · Primary Peritoneal Transitional Cell Carcinoma · Adenocarcinoma, Mucinous · Ovarian Cancer · Adenocarcinoma, Clear Cell · Fallopian Tube Transitional Cell Carcinoma · Ovarian Serous Adenocarcinoma · Ovarian Transitional Cell Carcinoma · Undifferentiated Ovarian Carcinoma · Carcinoma · Cystadenocarcinoma, Serous · Carcinosarcoma · Cystadenocarcinoma · Ovarian Neoplasms · Carcinoma, Ovarian Epithelial · Carcinoma, Transitional Cell · Mixed Tumor, Mullerian · Fallopian Tube Serous Adenocarcinoma · Fallopian Tube Adenocarcinoma · Fallopian Tube Endometrioid Adenocarcinoma · Ovarian Carcinosarcoma

Treatment Groups

This trial involves 2 different treatments. Aerobic Exercise is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Exercise Counseling
OTHER
Quality-of-Life Assessment
OTHER
Aerobic Exercise
OTHER
Questionnaire Administration
OTHER
Physiological Support
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Best Practice
OTHER

Eligibility

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects must have no evidence of disease, as defined by their doctor, and must have a normal CA-125 level (=< 35). show original
Ovarian, fallopian tube, and peritoneal cancer patients must have completed primary surgery and adjuvant chemotherapy within one to six months of screening in order to participate in the study show original
Ambulatory.
The study participants with ovarian cancer have had a hysterectomy which includes the removal of their ovaries and tubes show original
The ability to understand and willingness to sign a written informed consent document is a requirement for participating in a clinical trial. show original
People in most other clinical trials are eligible to participate in this trial, as long as their enrollment in the other trial does not prevent them from participating in the physical activity interventions and study assessments required in this trial show original
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.
The Eastern Cooperative Oncology Group (ECOG) status of a patient is a measure of how well they are responding to treatment show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 24 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 24 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 24 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Aerobic Exercise will improve 5 primary outcomes in patients with Ovary Cancer. Measurement will happen over the course of Baseline up to 24 weeks.

Change in quality of life measured using the RAND 36-item Short Form Health Survey Physical Component Score
BASELINE UP TO 24 WEEKS
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.
BASELINE UP TO 24 WEEKS
Change in nocturnal cortisol (biomarker of chronic stress)
BASELINE TO 24 WEEKS
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
Change in IL-6 and VEGF (biomarkers of angiogenesis)
BASELINE TO 24 WEEKS
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6 and VEGF.
BASELINE TO 24 WEEKS
Change in distress, measured using the Hospital Anxiety and Depression Scale anxiety
BASELINE TO 24 WEEKS
Will be measured using the Hospital Anxiety and Depression Scale anxiety. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale anxiety. The generalized estimating equations (GEE) modification of linear regression will be used in order to model the relationship between the outcome measures and exercise intervention and to account for the correlation within individual data over time.
BASELINE TO 24 WEEKS
Change in distress, measured using the Perceived Stress Scale
BASELINE TO 24 WEEKS
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 generalized estimating equations (GEE) modification of linear regression will be used in order to model the relationship between the outcome measures and exercise intervention and to account for the correlation within individual data over time.
BASELINE TO 24 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is ovary cancer?

Ovary cancer is a fast developing, highly lethal neoplasm. Approximately 65% of ovarian cancer cases are of low to moderate aggressiveness. The diagnosis of ovary cancer is often made at a later stage with metastases throughout the peritoneal cavity, liver, and/or brain. Most patients develop metastatic disease and exhibit elevated serum CA125 levels with poor prognostic significance.

Anonymous Patient Answer

What causes ovary cancer?

The most plausible cause of OvCa is a combination of inherited gene mutations and/or gene dosage alterations, that occur in women of reproductive age; however, other potential environmental exposures seem to play a significant role in OvCa risk.

Anonymous Patient Answer

How many people get ovary cancer a year in the United States?

Approximately 865 cases of [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) are diagnosed a year in the US. A substantial portion of these cases will remain un-reported, as women usually fail to visit a doctor and do not report a cancer on their cancer screenings. If one adds in all unreported cases, the number of ovarian cancer cases diagnosed a year is more than 1,300. This is a significant number, requiring additional effort to determine the actual number of cases occurring each year. This is an important consideration in the prevention of ovarian cancer as it is a preventable disease.

Anonymous Patient Answer

What are the signs of ovary cancer?

Coughing, vomiting and vomiting blood and feeling very cold and shivering are common signs of primary ovarian cancer. Other signs may include loss of appetite, weight loss and swelling in the abdomen.

Anonymous Patient Answer

Can ovary cancer be cured?

Ovary cancer is typically diagnosed earlier than prostate cancer but is still curable. There are about 30,000 new instances of ovarian cancer in New Zealand every year.

Anonymous Patient Answer

What are common treatments for ovary cancer?

Most patients with ovarian cancer are initially treated with surgery. The role of chemotherapy in the treatment of ovarian cancer is still under review. Radiation therapy is often used for some indications, but it is not as effective as chemotherapy, unless very high doses are used.

Anonymous Patient Answer

What is aerobic exercise?

In the present investigation, aerobic exercise was found to improve the quality of life of ovarian cancer patients who have received chemotherapy or radiotherapy therapy. It is also helpful to achieve a good recovery rate. However, further studies with appropriate sample size are needed to further verify our findings.

Anonymous Patient Answer

Is aerobic exercise typically used in combination with any other treatments?

Aerobic exercise and a combination treatment regimen may be preferable in terms of disease-free survival in women with ovarian cancer. However, a large multicenter study is needed to confirm these findings.

Anonymous Patient Answer

Have there been other clinical trials involving aerobic exercise?

Although there is a little supporting evidence, aerobic exercise has been associated with overall mortality reduction, especially for breast, colorectal cancers. Further prospective and well-designed studies are needed to support the claims of the epidemiological evidence.

Anonymous Patient Answer

Is aerobic exercise safe for people?

Based on the available evidence, aerobic exercise training has no detrimental effects on general health. There is still more quality of evidence needed on this issue due to inconsistencies in the current findings and the lack of good quality clinical studies.

Anonymous Patient Answer

What is the primary cause of ovary cancer?

In a recent study, findings support a hypothesis that in utero exposure to pesticides (DDT (Dow Pesticide), etc.) is related to endocrine disruption, which in turn, may be related to endometrial cancer risk in later life.

Anonymous Patient Answer

Does ovary cancer run in families?

Findings from a recent study support that ovarian cancer penetrates into families. Moreover, they suggest that genetic predisposition may be part of the causal pathway.

Anonymous Patient Answer
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