An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients

PRIMARY OBJECTIVES:

I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian
cancer patients who have undergone debulking surgery and will be starting platinum-based
chemotherapy, to an exercise trial.

II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary
to determine the feasibility of collecting tablet-based questionnaire data and blood samples
at multiple time points in one visit. It is also critical to determine whether the exercise
intervention is feasible in this patient population.

SECONDARY OBJECTIVES:

I. To examine changes in DNA repair function before and after a single exercise session.

II. To examine changes in DNA repair function, body composition, quality of life, symptoms
and patient satisfaction with care over the treatment time course.

III. To examine the effect of the exercise intervention on these measurements.

IV. To follow the patients an additional 12-months for clinical outcomes defined as death,
cancer recurrence, or new primary cancer.

OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day
1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or
unacceptable toxicity. Patients also receive a home-based exercise prescription including
instructions for keeping patients' heart rate within 50-80% maximum.

After completion of study, patients are followed up for 12 months.

Inclusion Criteria:

- Women who have been newly diagnosed with a first primary, epithelial ovarian cancer,
have undergone surgical debulking and who will be treatment according to the Armstrong
method

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for six months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately.

- Newly diagnosed, primary, epithelial ovarian cancer

- Have undergone surgical debulking

- Will be treated according to the Armstrong method

- Read and understand English

- All subjects must have the ability to understand and the willingness to sign a written
informed consent

Exclusion Criteria:

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study