A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT05901519
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Patients will be treated with PO prednisone, once a day, at a dose of 60 mg/day

Study Details

Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first three fractions of RT.

Key Dates

Start date
Feb 16, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients treated with Prednisone
    Prednisone will be administered for three days before starting RT, and during the first three fractions of RT. Following an interim analysis of the decrease in sTNFR1 level, a decision will be made whether to administer prednisone for seven days prior to RT, and to continue for additional seven days during RT.

Primary Outcome Measure

Mitigation of liver inflammation as reflected by sTNFR1 levels [ Time Frame: at baseline, day of first RT fraction, day of 3rd RT fraction and at 1-, 3- and 6-months post commencing radiation therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rogel Comprehensive Cancer CenterAnn ArborMichigan48187
Theodore Lawrence, M.D., Ph.D.
Theodore Lawrence, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Rogel Comprehensive Cancer Center· Ann Arbor, MI

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