Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

Assiut University44 enrolled

Overview

A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Acute Radiation Proctitis Acute Radiation Enteritis

Interventions

Hyaluronic AcidDRUG

Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water

PlaceboOTHER

Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.), * All patients who required adjuvant or radical radiation therapy; * Age \< 80 years; * Karnofsky Performance Status ≥ 60 Exclusion Criteria: * Patients were excluded if they had * gt; previous pelvic radiotherapy, * gt; inflammatory bowel disease or * gt; rectal issues (e.g., haemorrhoids). * Patients diagnosed with cancer rectum

Locations (2)

Ahmed Maher teaching hospitals

Cairo, Cairo Governorate, Egypt

Al-Ahrar teaching hospital

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

Time (in days) to occurrence of Acute Radiation Proctitis

Time frame: for each patient: time from the first day of radiation therapy for up to 3 months

Data from ClinicalTrials.gov

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