Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients
Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematopoietic Stem Cell Transplantation
Intervention: Propranolol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s): Jennifer Knight, MD, Principal Investigator, Affiliation: Medical College of Wisconsin
Overall contact: Cancer Center Clinical Trials Office, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu
Summary
This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic
antagonist propranolol is effective in decreasing gene expression of stress-mediated
beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic
stem cell transplant (HCT) for multiple myeloma.
Clinical Details
Official title: Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Change in beta-adrenergically mediated gene expression following beta-blocker administration
Secondary outcome: Change in depression and anxiety as a function of beta-blocker administrationIncidence of engraftment syndrome as a function of beta-blocker administration Rates of neutrophil and platelet engraftment as a function of beta-blocker administration Incidence of infection as a function of beta-blocker administration Differences in myeloma response as a function of beta-blocker administration Differences in treatment-related mortality as a function of beta-blocker administration Differences in progression-free survival as a function of beta-blocker administration Differences in overall survival as a function of beta-blocker administration
Detailed description:
This is a randomized controlled pilot study designed to evaluate whether a drug designed to
block the physiologic effects of stress is effective at blocking stress-related gene
expression in people receiving autologous stem cell transplants (their own cells) for
multiple myeloma. Such stress-related gene expression is one way that the body is programmed
to make specific proteins under conditions of stress. These proteins are believed to
contribute to worse health outcomes. By using the drug propranolol, we aim to see whether we
might block these negative health effects of stress as occur in the cancer setting and
during the transplant process. We hypothesize that individuals taking propranolol will have
more favorable gene expression.
We will enroll 40 individuals, randomizing half to receive propranolol and half to serve as
the control group not on the study drug. Study participants will start propranolol three
weeks prior to their transplant and continue it until 30 days after the transplant. We will
explore the effect of socioeconomic status, depression, and anxiety on individuals' gene
expression response to propranolol with the idea that the more impoverished, anxious, or
depressed individuals will display an even greater change in their gene expression. Part of
the purpose of this study is also be to assess whether it is feasible to give this drug to
individuals with cancer. Results of this study may inform larger trials assessing the
effects of propranolol on cancer progression.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients with multiple myeloma receiving an autologous HCT are eligible when the following
criteria are met:
1. 18-70 years of age (70 years is the MCW institutional limit to prescribe high dose
melphalan as a conditioning regimen)
2. ≤ 1 year since initiation of systemic anti-myeloma therapy
3. Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront
therapy for their multiple myeloma
4. Stable disease, partial response or very good partial response at time of study entry
5. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the
study
Exclusion Criteria:
1. Prior autologous HCT
2. Non secretory multiple myeloma
3. Concurrent beta-blocker therapy at or within 3 weeks of study entry.
4. Previous intolerance to beta-blocker therapy
5. Any medical contraindications to beta-blocker therapy including, but not limited to,
symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus
syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker;
uncompensated heart failure; or uncontrolled asthma
6. Active, untreated depression screened for by the HCT physician (Patients who screen
positive will be offered a referral to the MCW Psycho-Oncology program for further
evaluation and treatment)
7. Concurrent use of medications as specified in the protocol throughout the study or
within one week of study entry.
Locations and Contacts
Cancer Center Clinical Trials Office, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting Froedtert Hospital and the Medical College of Wisconsin, Phone: 866-680-0505, Ext: 8900, Email: cccto@mcw.edu
Additional Information
Starting date: July 2015
Last updated: July 21, 2015
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