Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
|ClinicalTrials.gov Identifier: NCT01308944|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Invasive Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer||Drug: Propranolol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2015|
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
- 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
- Progression free survival rates [ Time Frame: 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 [ Time Frame: Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo ]
- Characterization of biobehavioral states with surveys [ Time Frame: 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 [ Time Frame: At time of initial surgery ]Immunohistochemistry for VEGF, IL-6, IL-8, MMP-2 and MMP-9 will be performed on tumor samples.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308944
|United States, Missouri|
|Washington University in St. Louis|
|St Louis, Missouri, United States, 63110|
|Principal Investigator:||Premal Thaker, MD||Washington University School of Medicine|