We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

WISER After Ovarian Cancer - Exercise Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02529150
First Posted: August 20, 2015
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer Behavioral: Exercise Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Official Title: WISER After Ovarian Cancer - Exercise Pilot Study

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 26 weeks ]

Enrollment: 10
Study Start Date: May 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529150


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Kathryn Schmitz, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02529150     History of Changes
Other Study ID Numbers: UPCC 38814
First Submitted: June 19, 2015
First Posted: August 20, 2015
Last Update Posted: January 15, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders