- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469216
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis
June 17, 2024 updated by: Samar Gamal El Sheikh, Assiut University
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 055
- Recruiting
- Ahmed Maher teaching hospitals
-
Principal Investigator:
- Samar El Sheikh
-
Contact:
- Ahmed Maher hospital
- Phone Number: 02-23914455
- Email: ahmedmaher@gothi.gov.eg
-
-
Sharqia
-
Zagazig, Sharqia, Egypt, 055
- Recruiting
- Al-Ahrar teaching hospital
-
Contact:
- Al-Ahrar teaching hospital
- Phone Number: 0552362740
- Email: alahrar@gothi.gov.eg
-
Principal Investigator:
- Samar El Sheikh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 30 ml of Hyaluronic Acid (HA) enema will be given to the patients
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.
|
Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water
Other Names:
|
Placebo Comparator: 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients
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.
|
Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
for each patient: time from the first day of radiation therapy for up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
June 17, 2024
First Submitted That Met QC Criteria
June 17, 2024
First Posted (Actual)
June 21, 2024
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 17, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-2023-018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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