Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis.
OBJECTIVE
To determine whether a sucralfate oral solution can prevent/alleviate radiation-induced esophagitis.


METHODS
Patients included on this clinical trial were beginning thoracic radiation therapy to the mediastinum. Following stratification, they were randomized, in a double-blind manner, to receive a sucralfate solution or an identical-appearing placebo solution. Esophagitis was measured by physicians who used standard criteria and also by patients who used short questionnaires completed weekly during the course of the trial.


RESULTS
A total of 97 assessable patients were entered onto this clinical trial. During the first 2 weeks of the study, two placebo patients (4%) stopped their study medication, compared with 20 sucralfate patients (40%). This was related to substantially increased incidences of gastrointestinal toxicity (58% of sucralfate patients v 14% of placebo patients; P > .0001). There was no substantial benefit from the sucralfate in terms of esophagitis scores.


CONCLUSIONS
This oral sucralfate solution does not appear to inhibit radiation-induced esophagitis and is associated with disagreeable gastrointestinal side effects in this patient population.
McGinnis
W L
WL
Iowa Oncology Research Association Community Clinical Oncology Program (CCOP), Des Moines, USA.
Loprinzi
C L
CL
Buskirk
S J
SJ
Sloan
J A
JA
Drummond
R G
RG
Frank
A R
AR
Shanahan
T G
TG
Kahanic
S P
SP
Moore
R L
RL
Schild
S E
SE
Humphrey
S L
SL
D000284:Administration, Oral; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004941:Esophagitis / Q000188:drug therapy* / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries / Q000188:drug therapy* / Q000517:prevention & control; D013392:Sucralfate / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D013392:Sucralfate