USDOE Human Subjects Research Database, Fiscal Year 1998

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
Email: 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 Subjects Projects:

Number of Human Subjects Projects reported: 1

FNAL-98-98-98-01

Impedance-Controlled Microcurrent Therapy for Cancer Treatment Sequelae

Project Identifier: FNAL-98-98-98-01

Project Title:

Impedance-Controlled Microcurrent Therapy for Cancer Treatment Sequelae

Principal Investigator: Dr. Jeffrey Shafer
Principal Investigator's Institution: Provena Saint Joseph Hospital

Project started in: 1998

Fiscal Year 1998 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.

Funding Sources:

Non-Federal: Provena Saint Joseph Hospital Foundation

Amount: $10,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: November 06, 1997

Number of Human Subjects who participated in this project/protocol during FY 1998 (10/1/97 - 9/30/98): 38

Type of Human Subjects Involvement:

Other use of human subjects:

Use of microampere, low-frequency electrical current to reverse or decrease side effects in patients who previously received radiation therapy for cancer.

(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.