Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

Phase 1

Completed

• Conditions: Acute Radiation Enteritis; Acute Radiation Proctitis
• Interventions: Other: Placebo; Drug: Hyaluronic Acid

• Registration Number: NCT06469216
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients	Placebo	All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.
30 ml of Hyaluronic Acid (HA) enema will be given to the patients	Hyaluronic Acid	All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.

Primary Outcome Measures

Name	Time	Method
Time (in days) to occurrence of Acute Radiation Proctitis	for each patient: time from the first day of radiation therapy for up to 3 months

Trial Locations

Locations (2)

Al-Ahrar teaching hospital; 🇪🇬 Zagazig, Sharqia, Egypt

Ahmed Maher teaching hospitals; 🇪🇬 Cairo, Egypt