The fellowship training program outlined in this application is designed to increase the applicant's research and dissemination skills associated with the conduct of clinical trials to test the efficacy of interventions to promote symptom management and quality of life (QOL) in patients with cancer. Building on a strong clinical background as an advanced practice nurse and consistent with the National Institute of Nursing Research's research priorities, this new investigator's future program of research will focus on symptom management and QOL in cancer patients. Peripheral neuropathy (PNP) symptoms as a result of chemotherapy are prevalent in many cancer groups and specifically multiple myeloma (MM). Despite the relatively low incidence of MM, patients are living many years with even mild disturbing PNP symptoms that develop early in the disease due to newer therapies such as bortezomib. PNP is characterized by symmetric numbness and varying degrees of pain or tingling in the extremities. Patients experience a variety of sensations that range from mild discomfort and loss of sensation, to painful burning and cramping of the muscles that result in immobility, paralysis and diminished QOL. Little is known about PN prevention, treatment and symptom management in this population. Research in the form of prospective controlled trials in patients having MM with PNP symptoms that impair QOL is non-existent. Glutamine is an easily available, over the counter (OTC) oral agent that patients can take of their own accord for treatment of PNP, and many are doing so without professional counsel or evidence of efficacy. As adjuvant therapy in other cancer groups, oral glutamine has been shown to decrease the deleterious symptoms of PNP. All cancer treatments have associated costs and side effects that must be understood. Thus, development of empirical knowledge about the efficacy of glutamine (a readily available and often used over the counter agent) to delay the onset and severity of PNP symptoms in this population needs to be addressed to improve the health of MM patients who may live many years with this painful disorder. This randomized controlled trial will answer three questions: (1) Does glutamine decrease the incidence of PNP symptoms over time compared to placebo;(2) Does glutamine improve cancer treatment compliance and patient's ability to remain on anti-cancer therapy compared to placebo;and (3) Does glutamine improve QOL at 1 and 4 months following its use? To answer these questions, 70 patients will be recruited to participate in this randomized, double blind, placebo-controlled trial. Each participant who embarks on treatment with bortezomib will be randomized to receive glutamine or placebo. Measures the severity of PNP, QOL and compliance with chemotherapy will be obtained at baseline, 4 months.

Public Health Relevance

of Research to Public Health Previous studies suggest a correlation between decreased quality of life in patients with multiple myeloma who develop peripheral neuropathy (PNP) symptoms which may negatively affect public health. Their disability as a result of PNP will lead to a negative impact on society. Efforts to delay the onset and severity of peripheral neuropathy symptoms in this disparate population must be evaluated to improve the health of these individuals who may live many years with this painful disorder.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Predoctoral Individual National Research Service Award (F31)
Project #
5F31NR012345-02
Application #
8313217
Study Section
National Institute of Nursing Research Initial Review Group (NRRC)
Program Officer
Banks, David
Project Start
2011-07-21
Project End
2013-06-20
Budget Start
2012-07-21
Budget End
2013-06-20
Support Year
2
Fiscal Year
2012
Total Cost
$40,046
Indirect Cost
Name
Case Western Reserve University
Department
None
Type
Schools of Nursing
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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