Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Phase 1

Completed

• Conditions: Invasive Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
• Interventions: Drug: Propranolol

• Registration Number: NCT01308944
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Primary Completion: 2014-08
• Study Completion: 2015-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Propranolol	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of concurrent beta-blocker administration with chemotherapy	Completion of 6 cycles of chemotherapy/propranolol	Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol

Secondary Outcome Measures

Name	Time	Method
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	To characterize the biobehavioral states of these patients by using the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O), Hospital Anxiety and Depression Survey (HADS) and the Center for Epidemiologic Studies Depression Scale (CESD)
Evaluation of immunohistochemistry of angiogenic markers on tumor samples	At time of initial surgery	Immunohistochemistry for VEGF, IL-6, IL-8, MMP-2 and MMP-9 will be performed on tumor samples.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 St Louis, Missouri, United States