Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they had
Patients diagnosed with cancer rectum
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Maher teaching hospitals | Cairo | Cairo Governorate | 055 | Egypt | ||
| Al-Ahrar teaching hospital |
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water |
|
| Zagazig |
| Sharqia Province |
| 055 |
| Egypt |