Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
Washington University School of Medicine
First received: February 16, 2011
Last updated: August 14, 2015
Last verified: August 2015
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
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Primary Outcome Measures:
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| Primary Completion Date:
||August 2014 (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
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Preoperative Eligibility Criteria:
- Suspected preoperative diagnosis of invasive ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and CA-125 levels
- Patients must scheduled for a planned tumor debulking at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed Propranolol
- Intention for chemotherapy administration at Washington University
- An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian
- Age ≥ 18 years
- Gynecologic Oncology Group performance status 0-2
- Patient's of childbearing age must have a negative pregnancy test
- Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer are excluded.
- Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients with a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present with the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
- Use of systemic glucocorticoids such as Prednisone or Decadron in the last month
- Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English
- Cirrhosis of the liver
- Patients with a GOG Performance status 3 or 4
- Patients under the age of 18
- Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
- Any patients already on beta-blockers or contraindicated to receive beta-blockers
Post-operative Eligibility Criteria:
- Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer. Patients cannot receive concurrent bevacizumab or other targeted therapy as part of their primary chemotherapy.
- Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB)
- Patients with a synchronous primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
- Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01308944
|Washington University in St. Louis
|St Louis, Missouri, United States, 63110 |
Washington University School of Medicine
||Premal Thaker, MD
||Washington University School of Medicine
||Washington University School of Medicine
History of Changes
|Other Study ID Numbers:
10-0447 / 201104047
|Study First Received:
||February 16, 2011
||August 14, 2015
||United States: Institutional Review Board
Keywords provided by Washington University School of Medicine:
invasive epithelial ovarian cancer,
primary peritoneal carcinoma,
fallopian tube cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2016
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs