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Research

Program Research Contribution:

Dr. Adam Perlman, Executive Director, and Dr. Susan Gould Fogerite, Director of Research, with support from Ms Kimberly Phillips and Ms Yvette Dailey, continue 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.

Latest Research

Exploring Massage Benefits for Arthritis of the Knee (EMBARK) study

The goal of the EMBARK study, which is funded by the National Institutes of Health’s National Center for Complementary and Alternative Medicine, is to determine the optimal dose of massage for osteoarthritis of the knee sufferers.

If you have knee pain from osteoarthritis, you may be eligible to receive two months of massage therapy at no cost.

If you suffer from confirmed osteoarthritis of the knee, you may qualify for participation in a clinical research study exploring the effects of massage therapy. The study is being conducted by UMDNJ in conjunction with the Saint Barnabas Ambulatory Care Center in Livingston, NJ.

To qualify, you must:

* Be 35 years of age or older
* In general good health
* Have knee pain secondary to osteoarthritis

Individuals who qualify will receive study-related services free of charge. Participation will be required for a six month period.

For information or to see if you are qualify for this study, please call:
(973) 972-8564

Collaborative Research

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. This project received NIH funding in 2009.

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

RESEARCH HIGHLIGHTS

Basic Sciences

Completed research showing immunogenicity of certain cochleate formulations and adjuvants for subunit HIV vaccines, funded through a subcontract from an NIH SBIR grant

Established ICAM Research Laboratory

Clinical Sciences

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

Completed National Institutes of Health-funded collaborative pilot randomized controlled trial on external Qigong Therapy for Osteoarthritis for the Knee suggesting Qiqong provides improvement in function and pain relief

Demonstrated a trend toward improvement in pain in a National Institutes of Health-funded pilot study of IV Micronutrient Therapy for Fibromyalgia Syndrome

RESEARCH PROJECTS

Federal

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

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

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

The Effects of Almond Consumption on Pre-diabetes; PI, (original) M. Wein; PI (current) S. Gould Fogerite Ph.D., SHRP, Almond Board of California

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

Guided Imagery and Relaxation 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

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.

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.

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).

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.

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.

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.

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.

"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.

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.