USDOE Human Subjects Research Database, Fiscal Year 1999

Fermilab Neutron Therapy Facility

Public Information Contact:

Dr. Arlene J. Lennox
Fermilab Neutron Therapy Facility
P.O. Box 500 Mail Stop 301
Batavia, IL 60510-0500

Phone: 630-840-3865
Fax: 630-840-8766
E-mail: alennox@fnal.gov

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Provena Saint Joseph Hospital
The approving IRB does not operate under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).

Human Subject Projects:

Number of Human Subjects projects reported: 1

FNAL-98-98-98-01
"Impedance-Controlled Microcurrent Therapy for Cancer Treatment Sequelae"
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Project Identifier: FNAL-98-98-98-01

Project Title:
"Impedance-Controlled Microcurrent Therapy for Cancer Treatment Sequelae"

Principal Investigator: Dr. Jeffrey Shafer, Provena Saint Joseph Hospital

Project started in: 1998
This project ended in fiscal year 1999.

Project Funding Information:

This project received funding during fiscal year 1999.
This project used human subjects in fiscal year 1999.

Funding for Human Subjects Research:

Other: Provena Saint Joseph Hospital Foundation
$10,000.00 (Est.) for: Fiscal Year 1999

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 11/03/98

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 15
Reporting period for number of human subjects: Other: 10/01/98 to 05/05/99
Explanation:

Study is now closed.

Type(s) of Human Subjects Involvement:

Other types of human subjects involvement. Explanation:
Use of microampere, low-frequency electrical current to reverse or decrease side effects in patients who previously received radiation therapy for cancer.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

A. Objective: To relieve symptoms and improve quality of life for patients suffering from side effects following radiation therapy for cancer.

B. Methodology: Impedance-controlled microcurrent therapy is administered to the patient using electrodes.

C. Substances Used: A conductive gel similar to that used for electrocardiograms is applied to the skin to promote conductivity.

D. Involvement of Human Subjects: A therapist administers the treatment to the patient. There are no known risks, but patients using pacemakers or defibrillators are excluded from the study. Pregnant women are also excluded. Patients sign consent forms and agree to have the results published as long as their individual identities are not revealed. Their records are treated with the confidentiality normally required for patient medical records.

Go to list of projects at Fermilab Neutron Therapy Facility