WISER After Ovarian Cancer - Exercise Pilot Study

NCT02529150 | Completed DMC

• 1 other identifier: UPCC 38814
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  26 weeks

Study Arms (1)

exercise

EXPERIMENTAL

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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).

exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathryn Schmitz, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: August 20, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 6, 2016
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

US (1)