Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial.
OBJECTIVE
Evidence on which to base decisions about the management of radiation skin reactions is lacking. The purpose of this study was to investigate whether sucralfate or aqueous cream reduced acute skin toxicity during radiotherapy to the head and neck, breast or anorectal area (phase A), and to evaluate the effect of hydrogels and dry dressings on moist desquamation (phase B). This paper presents the results of phase A.


METHODS
Three hundred and fifty seven patients were randomised to apply aqueous cream, sucralfate cream or no cream to the irradiated area from day one of radical radiotherapy treatment. All patients were instructed to wash using unperfumed soap. Acute skin toxicity was measured using a modified radiation therapy oncology group (RTOG) score, reflectance spectrophotometry, patient diary card and dermatology life quality index (DLQI). A cost minimisation approach was used to compare the costs of each skin care approach.


RESULTS
No consistent differences were found in the severity of skin reactions or levels of discomfort suffered by patients in each of the randomised groups. Patients with a higher body mass index, who smoked, received concomitant chemotherapy, boost or bolus during treatment were more likely to develop skin reactions.


CONCLUSIONS
There is no evidence to support the prophylactic application of either of the creams tested for the prevention of radiation skin reactions. Our results show that it is possible to predict which patients are at greatest risk of skin reactions. We suggest that known risk factors should be incorporated into future study protocols.
Wells
Mary
M
School of Nursing and Midwifery, University of Dundee, 11 Airlie Place, Dundee DD1 4HJ, UK.
Macmillan
Maureen
M
Raab
Gillian
G
MacBride
Sheila
S
Bell
Nancy
N
MacKinnon
Karen
K
MacDougall
Hugh
H
Samuel
Leslie
L
Munro
Alastair
A
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004890:Erythema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D009369:Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D009824:Ointments; D011336:Probability; D011855:Radiodermatitis / Q000188:drug therapy* / Q000517:prevention & control; D011882:Radiotherapy, High-Energy / Q000009:adverse effects* / Q000379:methods; D018570:Risk Assessment; D012720:Severity of Illness Index; D013392:Sucralfate / Q000627:therapeutic use*; D016896:Treatment Outcome
D009824:Ointments; D013392:Sucralfate