NCT02878980

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

August 2, 2016

Last Update Submit

June 13, 2018

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed

    18 weeks

  • Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled

    12 months

Secondary Outcomes (7)

  • Change in body composition

    Baseline to 18 weeks

  • Change in DNA repair function, assessed by host reactivation assays

    Before single exercise session to after single exercise session, assessed up to 12 months

  • Change in DNA repair function, assessed by host reactivation assays

    Baseline to 18 weeks

  • Change in quality of life, assessed by questionnaires

    Baseline to 18 weeks

  • Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2

    Baseline to 18 weeks

  • +2 more secondary outcomes

Study Arms (1)

Arm I (exercise intervention)

EXPERIMENTAL

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.

Behavioral: Exercise InterventionOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Exercise InterventionBEHAVIORAL

Undergo supervised 1-on-1 exercise sessions

Arm I (exercise intervention)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (exercise intervention)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Arm I (exercise intervention)
Questionnaire AdministrationOTHER

Ancillary studies

Arm I (exercise intervention)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Jessica Clague DeHart, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 25, 2016

Study Start

September 2, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

US(1)