Evaluation of the Radioprotective Effect of Famotidine Against Radiotherapy- induced Acute Toxicity in Patients with Prostate Cancer

A Randomized controled trial of Famotidine as a Radioprotector agent versus Placebo before External Beam Radiotherapy in Patients with Prostate Cancer to Reduce Radiation- induced Acute Bowel & Urinary Toxicity using RTOG Criteria

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000101886

Enrollment

Registered

2012-01-20

Start date

2012-04-17

Completion date

2013-02-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is some animal and human cell evidences to support a Radioprotectory role for Famotidin. In the last few years there has been increasing interest to find a suitable Radioprotector agent for Radotherapy. The aims of this trial are to 1) determine the efficacy of Famotidine to prevent of bowel Radiation-Induced Toxicity 2) determine the efficacy of Famotidine to prevent of Urinary Radiation-Induced Toxicity 3) determine the efficacy of Famotidine to prevent of Immune system Radiation-Induced Toxicity

Interventions

Oral Famotidine 40mg is administrated daily for 2 months twice per day before 2 months Radiotherapy: Once 4 hours before and the other 3 hours before daily Radiotherapy. A Physician determines Bowel & Urinary Toxicities Grade for the patients every week during the treatment by interviewing and blood cell counts are collected biweekly.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Patients with Prostate Cancer Candidate for External Beam Radiotherapy

Exclusion criteria

Patients with Metastatic Prostate Cancer, Patients with Kidney & Liver dysfunction, Patients who receive any H2– Histamine receptor antagonist simultaneously, Patients with Allergic reaction in consequence of Famotidine Administration.

Outcome results