A Phase 1/2 interventional study of Hyaluronic Acid and Placebo in Acute Radiation Proctitis and Acute Radiation Enteritis, sponsored by Assiut University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Assiut University · Phase 1/2, Interventional, and Prevention
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.
34 studies on the registry are indexed under Enteritis; 7 are open to participants now.
This study's enrollment of 44 is below the median of 53 across 26 interventional studies indexed under Enteritis.
Browse Enteritis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients were excluded if they had
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water
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
Ran from Apr 2024 to primary completion in Dec 2024, 8 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid