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Clinical Trials/NCT01308944
NCT01308944
Completed
Phase 1

Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Washington University School of Medicine1 site in 1 country24 target enrollmentAugust 2010

Overview

Phase
Phase 1
Intervention
Propranolol
Conditions
Invasive Epithelial Ovarian Cancer
Sponsor
Washington University School of Medicine
Enrollment
24
Locations
1
Primary Endpoint
Feasibility of concurrent beta-blocker administration with chemotherapy
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This research is looking at the effect of biobehavioral factors such as stress and whether these factors alter how the body responds to chemotherapy, one of the purposes of this study is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer. An additional purpose of the study is to understand if behavioral factors such as depression and anxiety can alter different blood markers that affect tumor vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such as Inderal, might alter these behavioral factors by drawing blood prior to and after the administration of Inderal as well as giving behavioral questionaires at different time points. Beta-blockers are commonly used for the treatment of hypertension, protection of the heart after a heart attack, and irregularities in heartbeats. Altering these factors might boost the immune system and affect other areas of cancer biology, thereby allowing the chemotherapy to be more effective. The significance of this research is that it may help improve our treatments of this disease in the future.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
August 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm 1

Propranolol 40mg po orally twice daily to begin at least 48 hours prior to surgical debulking. This will ideally be titrated in order to maintain a heart rate between 60 and 80 without hypotension. After surgery, the patient will resume the propranolol once tolerating clear liquids in the hospital and will remain on them until completion of chemotherapy. After completion of chemotherapy, the patient will be weaned off the medication over the following two weeks.

Intervention: Propranolol

Outcomes

Primary Outcomes

Feasibility of concurrent beta-blocker administration with chemotherapy

Time Frame: Completion of 6 cycles of chemotherapy/propranolol

Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol

Secondary Outcomes

  • Progression free survival rates(From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery)
  • Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade(Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo)
  • Characterization of biobehavioral states with surveys(Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo)
  • Evaluation of immunohistochemistry of angiogenic markers on tumor samples(At time of initial surgery)

Study Sites (1)

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