Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
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.
Invasive Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients|
- Feasibility of concurrent beta-blocker administration with chemotherapy [ Time Frame: Completion of 6 cycles of chemotherapy/propranolol ] [ Designated as safety issue: No ]Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol
- Progression free survival rates [ Time Frame: From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery ] [ Designated as safety issue: No ]
- Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade [ Time Frame: Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo ] [ Designated as safety issue: No ]
- Characterization of biobehavioral states with surveys [ Time Frame: Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo ] [ Designated as safety issue: No ]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 [ Time Frame: At time of initial surgery ] [ Designated as safety issue: No ]Immunohistochemistry for VEGF, IL-6, IL-8, MMP-2 and MMP-9 will be performed on tumor samples.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Name: Inderal
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308944
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|St Louis, Missouri, United States, 63110|
|Contact: Premal Thaker, M.D. 314-362-3181 firstname.lastname@example.org|
|Principal Investigator: Premal H Thaker, M.D.|
|Sub-Investigator: David G Mutch, M.D.|
|Sub-Investigator: Leslie S Massad, M.D.|
|Sub-Investigator: Matthew A Powell, M.D.|
|Sub-Investigator: Andrea Hagemann, M.D.|
|Sub-Investigator: Nora Kizer, M.D.|
|Sub-Investigator: Yevgeniya Ioffe, M.D.|
|Sub-Investigator: Gunjal Garg, M.D.|
|Sub-Investigator: Akiva Novetsky, M.D.|
|Sub-Investigator: Theresa DeShields, Ph.D.|
|Sub-Investigator: Phyllis Huettner, M.D.|
|Principal Investigator:||Premal Thaker, MD||Washington University School of Medicine|