Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis

NCT06469216 | Completed Phase 1

• 1 other identifier: 05-2023-018
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Radiation Proctitis; Acute Radiation Enteritis

Keywords

double blind; placebo control; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

30 ml of Hyaluronic Acid (HA) enema will be given to the patients

ACTIVE COMPARATOR

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.

Drug: Hyaluronic Acid

30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

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

Also known as: Sodium Hyaluronate

30 ml of Hyaluronic Acid (HA) enema will be given to the patients

Placebo OTHER

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

30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Ahmed Maher teaching hospitals

Cairo, Cairo Governorate, 055, Egypt

Location

Al-Ahrar teaching hospital

Zagazig, Sharqia Province, 055, Egypt

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist at Al-Ahrar Oncology Center

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (2)