Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

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.

Completed

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Key information

Conditions

Acute Radiation Proctitis Acute Radiation Enteritis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ahmed Maher teaching hospitals, Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

Drug

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

Other names: Sodium Hyaluronate

Placebo

Other

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

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 21, 2024
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed