A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis

OBrien, Peter C., Franklin, C.Ian, Dear, Keith B.G., Hamilton, Christopher C., Poulsen, Michael, Joseph, David J., Spry, Nigel and Denham, James W. (1997) A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis. Radiotherapy and Oncology, 45 2: 117-123. doi:10.1016/S0167-8140(97)00146-1

Author OBrien, Peter C.
Franklin, C.Ian
Dear, Keith B.G.
Hamilton, Christopher C.
Poulsen, Michael
Joseph, David J.
Spry, Nigel
Denham, James W.
Title A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis
Journal name Radiotherapy and Oncology   Check publisher's open access policy
ISSN 0167-8140
Publication date 1997-11
Sub-type Article (original research)
DOI 10.1016/S0167-8140(97)00146-1
Volume 45
Issue 2
Start page 117
End page 123
Total pages 7
Place of publication Shannon, Co. Clare Ireland
Publisher Elsevier
Language eng
Formatted abstract
Background and purpose:
A limited number of studies have suggested that oral sucralfate reduces the acute and late gastro-intestinal side-effects of pelvic radiotherapy and sucralfate enemas ameliorate symptoms of chronic proctitis. Sucralfate may act via local bFGF at the mucosal level in promoting angiogenesis and reducing epithelial associated microvascular injury. This multi-institutional study was designed to test the hypothesis that sucralfate given as an enema would have a significant protective effect against acute radiation induced rectal injury by direct application to the mucosa.

Materials and methods:

Eighty-six patients having radiotherapy for localised carcinoma of the prostate were randomised in a double-blind placebo-controlled study to receive either 15 ml of placebo suspension or 3 g of sucralfate in 15 ml suspension, given as a once daily enema during and for 2 weeks following radiotherapy. Assessment was based on the EORTC/RTOG acute toxicity criteria and a patient self-assessment diary.

There was no significant difference between placebo and sucralfate for peak incidences of EORTC/RTOG proctitis. For the placebo and sucralfate arms 95 and 88% (difference 7 ± 11%) suffered some degree of proctitis, with 71 and 61% (difference 10 ± 19%) reaching grade 2, respectively. The median period to onset of grade 2 proctitis was 33.5 and 36 days, with the median duration being 9.5 and 15 days, respectively, again these difference being non- significant. Thirty-five and 37% of patients rated the effect of radiotherapy on bowel habit as 'a lot' with a moderate or severe effect on normal daily living in 52 and 49%, respectively.


This study suggests that sucralfate given as a once daily enema does not substantially reduce the incidence of symptoms associated with acute radiation proctitis and its routine clinical use cannot be recommended. This cohort of patients will be followed to determine if any difference develops in relation to late toxicity.
Keyword Proctitis
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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Created: Tue, 23 Nov 2010, 14:47:04 EST