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PROGRAM RESEARCH CONTRIBUTION
:
Dr. Adam Perlman , Executive
Director , and Dr. Susan Gould Fogerite, Director of Research, with
support from Ms. Crystal Jones and Ms. Yvette Dailey, have continued
to bring forward work on their funded research projects, while building
the research base of the Institute. All of the current projects
are interdisciplinary and collaborative, with many including investigators
not only from other UMDNJ schools, but also from other Institutions.
•
SHRP Collaborative Research
Nutrition
•
The Effects of Almond Consumption
on Pre-diabetes ; (original
PI) M. Wein; Dr Ph, RD, (current PI) S. Gould Fogerite Ph.D., J.
O.Sullivan Maillet, PhD, RD, R.Touger Decker, PhD, RD, FADA, E.Z.
Anderson, PT, MA, GCS SHRP, B. Greenberg, PhD, NJDS, D. Bleich,
MD, M. Raghushwanshi, MD, NJMS. Almond Board
of California . Ongoing 2008, in extension.
Rehabilitation
and Movement Sciences
•
The Effect of Supervised Exercise
Training on Immune, Physical, and Psychological Status in Breast
Cancer Patients during their Initial Cycle of Chemotherapy
; P.I.: B. Gladson, Ph.D., Co-P.I.: S. Gould Fogerite, Ph.D., M.J.
Myslinski, SHRP, R. Musanti, PhD, SON, L. Pliner, MD N. Ponzio,
PhD, NJMS, Newark, UMDNJ Foundation. Ongoing
2008-Recruitment about to start.
•
UMDNJ Team Science Grant to
fund additional patients and laboratory testing for above cancer
exercise clinical study . Submitted in December
2007, will be ongoing in 2008 if funded.
•
Hormones of Stress and Inflammation
in pre-Diabetes; PI, S.
Gould Fogerite, Ph.D., Co-investigator, Professor E. Anderson.
SHRP preliminary Foundation grant submitted January
2008.
•
Dental School Collaborative Research
•
Guided Imagery and Relaxation Techniques as an Adjunct to Preparing
and Recovering from Orthognathic Surgery ; P.I. S. Aziz, DMD,
MD, NJDS, Co-Inv. S. Gould Fogerite, Ph.D., SHRP, UMDNJ Foundation.
IRB proposal to be submitted in February 2008, recruitment
to start immediately following IRB approval.
•
PhD student Robert Femminella will be helping with the above
study, and will be analyzing blood samples for markers of stress
and inflammation as part of his PhD thesis research.
•
ICAM Industry Sponsored Research
•
An Open Pilot Clinical Trial to Evaluate the Safety of Propranolol
in Combination with Etodolac in Subjects Diagnosed with Metastatic
Cancer and Secondary Outcomes of Weight, Inflammatory Markers and
Quality of Life ; Co-PI. S. Gould Fogerite, Ph.D., SHRP, Vicus
Therapeutics. Study closed 2007.
•
A Retrospective Study on Accumulated Data Files to Identify and
Compare the Interactions and Differences between the Diagnoses of
Cachexia as Compared to Anorexia ; P.I.: S. Gould Fogerite,
Ph.D., SHRP, Vicus Therapeutics. Research completed in
2007.
•
Other ICAM Research Projects Submitted and
in Development
•
Massage for Osteoarthritis of the Knee. PI, A.
Perlman, MD, Co-inv. S. Gould Fogerite, (and others).
SGF made major contributions to this grant proposal and will play
a significant role if funded. The grant provides for a portion of
her salary support, as well as Dr. Chen's salary, and for extensive
testing to be done in the ICAM Research Lab. It is hoped that this
project will be funded in 2008.
•
Yoga for HIV infected Youth. PI, Susan
Gould Fogerite, Adam Perlman , co-Investigator (and others), direct
costs budget $400,000. Submitted to NIH January 2007. Not funded.
Redesigning and resubmitting, potentially with adults from Broadway
House for Continuing Care as the HIV positive patient population.
•
Project for Expansion and Assessment
of CAM and Wellness Program. PI, Susan Gould Fogerite, co-Investigator,
Adam Perlman, Nancy Urff, co-Investigators, Broadway House for Continuing
Care. Proposal in development to be submitted to the Healthcare
Foundation of New Jersey within the next few months.
•
Yoga for Multiple Sclerosis. PI, S. Gould
Fogerite, Ph.D., R. D. Alkalay, ND, PhD, and R. Oliker, MD. This
clinical trial investigating the safety and efficacy of a specially
designed integrative yoga program for individuals with MS, is well
along in the design and proposal development phase. The plan is
to submit for Private funding (National MS Society and others) within
the next two months.
•
Guided Imagery Vs. Combined Guided Imagery with Amitriptyline for
RAP of Childhood" PI, Nader Youseff, Co-Investigators, Adam Perlman
and Susan Gould Fogerite. Originally submitted to NIH, NCCAM in
Feb 2005, revised and resubmitted, Nov. 2005 and November 2006.
Project has been redesigned and submitted to NIH, NIDDK (Feb 4,
2008.
Nutritional Intervention for
Management of Diabetes (not final title). PI, J. Fuhrman, MD, Co-Inv.s
J. Petrillo,MD, S. Gould Fogerite, PhD, and A.Perlman, MD. This trial
to be done in the Orange County Florida School District , testing
a nutritional program developed by Dr. Fuhrman, is in the IRB proposal
stage. The plan is to submit to the IRB in the next few weeks. Albert
Grazia will be assisting and analyzing clinical samples from this
trial for markers of inflammation and diabetes as part of his PhD
thesis research
•
An Open Pilot Clinical Trial to Evaluate the Safety of Propranolol
in Combination with Etodolac in Subjects Diagnosed with Metastatic
Cancer and Secondary Outcomes of Weight, Inflammatory Markers and
Quality of Life ; Co-PI. S. Gould Fogerite, Ph.D., SHRP, Vicus
Therapeutics. Study closed 2007.
•
A Retrospective Study on Accumulated Data Files to Identify and
Compare the Interactions and Differences between the Diagnoses of
Cachexia as Compared to Anorexia ; P.I.: S. Gould Fogerite,
Ph.D., SHRP, Vicus Therapeutics. Research completed in
2007.
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RESEARCH HIGHLIGHTS
Basic Sciences
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Completed research showing immunogenicity of certain cochleate
formulations and adjuvants for subunit HIV vaccines, funded
through a subcontract from an NIH SBIR grant
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Established ICAM Research Laboratory
Clinical Sciences
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Showed safety and efficacy
(reduced pain and increased function) of Massage Therapy for
Osteoarthritis (OA) of the Knee in Centers for Disease Control-funded,
randomized, controlled pilot study
-
Published OA Massage
study as a peer-reviewed article in Archives of Internal Medicine
, which generated coverage by NY
Times and 3 major TV stations
RESEARCH PROJECTS
Federal
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Prevalence of Complementary
and Alternative Medicine (CAM) Use and Disclosure to Healthcare
Providers in a Complementary Cancer Center ; PI: A. Perlman,
MD, MPH, SHRP; National Cancer Institute, National Institutes
of Health
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Safety and Efficacy
Study of Vagus Nerve Stimulation (VNS) Using the Neurocybernatic
Prosthesis (NCP) System in Patients with Refractory Fibromyalgia
with and without Concurrent Major Depression ; Co-Inv: A.
Perlman, MD, MPH, SHRP; The National
Institute of Arthritis and Musculoskeletal and Skin Diseases
, National Institutes of Health
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Novel Adjuvants
for HIV Vaccines : PI: S. Gould Fogerite, PhD. Grant Period
Nov 15, 2004 to July 31, 2006 . National Institutes of Health,
Subcontract from BDSI, Inc .
Private Industry
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An Open Pilot Clinical Trial to Evaluate the Safety of Propranolol
in Combination with Etodolac in Subjects Diagnosed with Metastatic
Cancer and Secondary Outcomes of Weight, Inflammatory Markers
and Quality of Life ; Co-PI. S. Gould Fogerite, Ph.D., SHRP,
Vicus Therapeutics
-
A Retrospective
Study on Accumulated Data Files to Identify and Compare the
Interactions and Differences between the Diagnoses of Cachexia
as Compared to Anorexia ; P.I.: S. Gould Fogerite, Ph.D.,
SHRP, Vicus Therapeutics
-
The Effects of Almond
Consumption on Pre-diabetes ; PI, (original) M. Wein; PI
(current) S. Gould Fogerite Ph.D., SHRP, Almond Board of
California
Internal UMDNJ
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The effect of supervised
exercise training on immune, physical, and psychological status
in breast cancer patients during their initial cycle of chemotherapy
; P.I.: B. Gladson, Ph.D., Co-P.I.: S. Gould Fogerite, Ph.D.,
SHRP, UMDNJ Foundation
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Guided Imagery and
Relxation Techniques as an Adjunct to Preparing and Recovering
from Orthornathic Surgery ; P.I. S. Aziz, DMD, MD NJDS, Co-Inv.
S. Gould Fogerite, Ph.D., SHRP, UMDNJ Foundation.
PROGRAM DETAILS
AND UPDATES
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ICAM
Research Lab : The organization and expansion
of the ICAM
Research Lab was a primary research focus this year.
This state of the art research lab serves as a base where
NIH and other public, as well as privately funded, basic
and clinical research can be performed. The laboratories
are located in GB 156, 157 and 159 within the Clinical Lab
Sciences area of SHRP in the Stanley S Bergen Building,
with approximately 2,400 square feet of prime laboratory
space including a tissue culture lab, autoclave, glassware
washing facilities, wet and dry lab bench space, storage,
and desk space. The Laboratory contains supplies, glassware
and other equipment necessary to perform research including
a water purification system, refrigerators, minus 20 and
minus 80 degree Revco freezers, biosafety hoods, a chemical
hood, a microplate reader, plate washer, incubators, centrifuges,
spectrophotometers, balances, pH meter, automatic and micro
pipettors, vortexes, stirrers, heaters and other small equipment.
The focus of the research is on stress and inflammation,
including infection and diabetes. The laboratory has been
organized and clinical samples are being received and assayed.
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Open
House : An Open House was held for the laboratory
in October 2006. This successful event, attended by numerous
individuals from various schools and departments throughout
UMDNJ, introduced the laboratory and its research capabilities.
Good publicity for SHRP, ICAM and Clinical Lab Sciences,
who co-sponsored the event, leads for potential collaboration
and service, were achieved.
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Research
Staff : Dr. Zi-Wei Chen, an experienced Research
Scientist, worked on the NIH grant subcontract for subunit
HIV vaccines and helped organize the ICAM Research Lab.
Dr. Chen is currently working on the Almond Study (see below).
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SHRP
Clinical Trial : Dr. Gould Fogerite established
collaboration with Dr. Michelle Wien, of the SHRP Nutrition
Program, to determine levels of various inflammatory and
diabetes-related markers for Dr. Wien's clinical trial on
"The Effects of Almond consumption on Pre-diabetes" in the
ICAM Lab. Dr. Gould Fogerite became PI on this project in
June 2006 when Dr. Wien left the university. The laboratory
has been processing and storing clinical samples for the
past year. Laboratory and data analysis for this project
is ongoing, with excellent quality results being obtained.
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Interdepartmental
Collaboration on Exercise for Chemotherapy Patients :
Dr. Gould Fogerite has worked closely with Dr.
Barbara Gladson and Mary Jane Myslinski, of the SHRP Physical
Therapy Program, and Rita Musanti of Nursing, to develop
and write protocols and IRB documents for a UMDNJ Foundation
grant project. This study is to determine the effectiveness
of a supervised exercise program, tailored to the individual
patient's capabilities, and designed by the investigators
specifically for breast cancer patients, on improving outcomes
of physical, psychological and immune status. Co-investigators
also include an oncologist from University Hospital , Dr.
Lillian Pliner, and Dr. Nick Ponzio of Pathology and Neurology.
The ICAM Lab will be performing assays for these studies.
Recruitment will begin in the Fall of 2007.
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ICAM's
first Commercially-funded Clinical Trial : Dr.
Gould Fogerite was Co-PI, with Dr. Lawrence Harrison, head
of Surgical Oncology, on this study of a novel drug combination
for efficacy in cancer cachexia. The study was a collaboration
with Vicus Therapeutics, SPE I, a New Jersey-based biotech
company, and University Hospital Cancer Research Office
and oncologists. Positive results were obtained in this
trial. The study has recently closed due to lack of patients
that met enrollment criteria at this site.
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Retrospective
Chart Study : A related trial of deceased
cancer patient's charts to determine whether cachexia or
anorexia was present during terminal phases has also been
funded by Vicus Therapeutics. Dr. Gould Fogerite is PI on
this study. IRB approval was obtained, research has commenced,
and will continue. This trial should be completed in the
Fall of 2007.
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" CAM
and Cancer" Dr. Gould Fogerite was the recipient
of a 2006 Summer Student Research Project Award funded by
the UMDNJ Foundation. Ms. Christa Visotsky, of the SHRP
Physician's Assistant program, received a $2,000 stipend
for her work with Drs. Gould Fogerite and Perlman on research
on Complementary and Alternative Medicine for breast cancer.
A review article for a CAM journal is being written.
• New
Jersey Dental School grant : Dr Gould Fogerite
formed a new collaboration with Dr. Shahid Aziz of the Dept
of Oral and Maxilofacial Surgery of NJDS. They submitted a proposal
entitled, "Guided Imagery and Relaxation Techniques as an Adjunct
to Preparing and Recovering from Orthognathic Surgery"; P.I.
S. Aziz, DMD, MD, NJDS, Co-Inv. S. Gould Fogerite, Ph.D., SHRP,
which was funded by the UMDNJ Foundation. IRB documents
and further protocol development will commence shortly.
• Dean's Excellence
in Research Award: Dr Adam Perlman received the
SHRP Dean's Excellence in Research Award at the UMDNJ School
of Health Related Professions, 2007, Twenty-Seventh Annual Recognition
Dinner.
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Research Grants
Submitted:
•
"Guided Imagery Vs. Combined Guided Imagery with Amitriptyline
for RAP of Childhood" PI, Nader Youseff, Adam Perlman
and Susan Gould Fogerite Co-Investigators. Direct costs
budget $400,000. Originally submitted to NIH Feb 2005
(Score 217). Revised and resubmitted, Nov. 2005 (scored
175). Revised and resubmitted November 2006 (score 187).
Not funded. To be redesigned and submitted.
•
"Yoga for HIV infected Youth", PI, Susan Gould Fogerite,
Adam Perlman , co-Investigator (and others), direct costs
budget $400,000. Submitted to NIH January 2007. Not funded.
To be revised and resubmitted.
•
"IV micronutrient Therapy for Fibromyalgia". PI, David
Katz, Adam Perlman , co-Investigator. Direct costs budget
$1,979,919. Submitted to NIH January 2006. Not funded.
To be revised and resubmitted.
•
"Guided Imagery and Relaxation Techniques as an Adjunct
to Preparing and Recovering from Orthognathic Surgery";
P.I. S. Aziz, DMD, MD, NJDS, Co-Inv. S. Gould Fogerite.
Direct costs $6,000. Submitted to NJDS April 2007. Funded
by the UMDNJ Foundation.
•
"Massage for Osteoarthritis of the knee". Direct cost
budget $2,748,907 . Submitted to NIH, June 2006. Awaiting
results of review.
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