Acute Radiation Enteritis, Acute Radiation Proctitis
Conditions
Keywords
double blind, placebo control, Randomized Clinical Trial
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.
Interventions
DRUGHyaluronic Acid
Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water
OTHERPlacebo
Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed