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

Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02878980
• Other study ID #: 15388
• Secondary ID: NCI-2016-0118315
• Status: Withdrawn
• Phase: N/A
• Start date: September 2, 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Behavioral:
• Exercise Intervention
Undergo supervised 1-on-1 exercise sessions

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed		18 weeks
Primary	Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled		12 months
Secondary	Change in body composition	Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.	Baseline to 18 weeks
Secondary	Change in DNA repair function, assessed by host reactivation assays	Will be analyzed using paired t-tests	Before single exercise session to after single exercise session, assessed up to 12 months
Secondary	Change in DNA repair function, assessed by host reactivation assays	Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.	Baseline to 18 weeks
Secondary	Change in quality of life, assessed by questionnaires	Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.	Baseline to 18 weeks
Secondary	Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2	Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.	Baseline to 18 weeks
Secondary	Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General	Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.	Baseline to 18 weeks
Secondary	Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer		Up to 12 months