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
Drug: Propranolol (Inderal)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients|
- Feasibility of concurrent beta-blocker administration with chemotherapy [ Time Frame: patients who successfully complete 6 cycles of chemotherapy and will be followed for 12 months post chemo ] [ Designated as safety issue: No ]To determine the feasibility of pharmacologic beta-blockade along with the administration of either intravenous or intraperitoneal chemotherapy of standard taxane and platinum chemotherapy for six cycles. Patients with suspected ovarian, fallopian, or primary peritoneal cancer will be approached pre-operatively and will start on Inderal and will continue this post-operatively and during chemotherapy. The number of participants with adverse events will be noted as a measure of safety and tolerability of taxane and platinum chemotherapy with beta-blockers.
- Progression free survival rates [ Time Frame: 18 months following surgery ] [ Designated as safety issue: No ]The secondary endpoint is progression free survival from time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery, whichever is later. Since this is a feasibility study and different routes of administration of chemotherapy along with varying amounts of surgical debulking will occur, the progression-free survival will be used to guide future trials.
- Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade [ Time Frame: 12 months ] [ Designated as safety issue: No ]Translational objectives in this pilot study include determining VEGF, IL-6, IL-8, MMP-2 and MMP-9 serum levels in patients with ovarian cancer who are receiving beta blockers and comparing these levels pre-treatment and during treatment with chemotherapy.
- Characterization of biobehavioral states with surveys [ Time Frame: 12 months ] [ 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) at pre-surgery and during chemotherapy administration.
- Evaluation of immunohistochemistry of angiogenic markers on tumor samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]Immunohistochemistry for IL-6, IL-8, MMP-2 and MMP-9 will be performed on tumor samples.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Beta-blocker and pelvic mass concerning for ovarian cancer
This is an observational study to see if the addition of propranolol 40mg po twice daily pre-operatively, post-operatively, and during chemotherapy for ovarian, fallopian tube, or primary peritoneal cancers can cause changes in the tumor microenvironment and biological markers in patients. There is only one arm to the trial.
Drug: Propranolol (Inderal)
Propranolol 40mg is taken by mouth twice a day and started at least 48 hours prior to surgery
Other Name: Inderal
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|St Louis, Missouri, United States, 63110|
|Contact: Premal Thaker, MD 314-362-3181 firstname.lastname@example.org|
|Contact: Kirthika Vijayakumar 314-362-6196 email@example.com|
|Principal Investigator:||Premal Thaker, MD||Washington University School of Medicine|