Clinical trial NCT02878980: An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
Official title: An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ovarian Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-25
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies how well an exercise intervention works in reducing symptoms and improving clinical outcomes in patients with ovarian cancer undergoing platinum-based chemotherapy. Exercise may "train" the body to repair deoxyribonucleic acid (DNA) damage more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve quality of life, increase survival, and decrease recurrence rates in patients with ovarian cancer.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
timeFrame: 18 weeks
measure: Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled
timeFrame: 12 months
Secondary outcomes:
measure: Change in body composition
timeFrame: Baseline to 18 weeks
measure: Change in DNA repair function, assessed by host reactivation assays
timeFrame: Before single exercise session to after single exercise session, assessed up to 12 months
measure: Change in DNA repair function, assessed by host reactivation assays
timeFrame: Baseline to 18 weeks
measure: Change in quality of life, assessed by questionnaires
timeFrame: Baseline to 18 weeks
measure: Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2
timeFrame: Baseline to 18 weeks
measure: Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General
timeFrame: Baseline to 18 weeks
measure: Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jessica Clague DeHart, PhD
role: PRINCIPAL_INVESTIGATOR
References: