WISER After Ovarian Cancer - Exercise Pilot Study

One in four deaths in the United States is due to cancer, and one in three women will develop cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore, interventions focused on preventing recurrence or slowing progression of EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a dose response exercise intervention trial to examine the dose response effects of aerobic exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like assurance that the investigators can recruit ovarian cancer patients into an exercise study and that these women will do the exercise protocol we plan to prescribe in our high dose of exercise.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of stage III-IV EOC, completed surgery,
• > 12 months life expectancy (physician estimate),
• able to walk 15 minutes at a time (use of a cane is acceptable).

Exclusion Criteria:

• medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or
• orthopedic history that would prohibit a program of walking for exercise;
• psychotic disorders,
• dementia,
• inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise	Behavioral: Exercise; This is an exercise intervention study. All 10 participants will complete 26 weeks high dose exercise (60% of peak aerobic capacity 45 min/session, 5 sessions per week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	26 weeks

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 6, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: UPCC 38814