Kirova_2011
Supportive Therapie · Version 2.1
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Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum
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Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme |
Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle |
Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
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Kirova
2011
Radiotherapy and Oncology |
randomised, open-label, monocentric, phase III trial
n = 200
France
04/2005 – 10/2008 |
Breast cancer patients with grade 1–2 radio-induced dermatitis during postoperative radiotherapy
Hyaluronic acid Age, median (range): 53 (28–76) BMI, median (range): 23.7 (15.6–38.4)
Emollient Age, median (range:) 53 (27–83) BMI, median (range): 23.4 (18.0–42.5) |
N = 99 hyaluronic group
100 mg tube of Ialuset® containing 200 mg of hyaluronate sodium, Genevrier, France) |
101 simple emollient group
200 ml tube of Topicrem® containing urea 2% and glycerol 9.5%, Charlieu, France |
primary endpoint: clinical evaluation of the erythema (success versus failure)
Secondary endpoints: evaluation of skin colorimetry, pain, and quality of life. |
Hyaluronic acid vs. Emollient
ITT population 27 failures (27.3%) vs. 38 (37.6%) (p = 0.12)
95 evaluable pts 23 failures (24.2%) vs. 32 (33.7%) (p = 0.15)
risk factors for treatment failure:
BMI: mean BMI 25.9 kg/m2 in patients with treatment failure vs. 22.7 kg/m2 in patients with successful treatment; p = 0.0002
baseline size of the epithelitis: means of respectively 2606 mm2 versus 2369 mm2 ; p = 0.005
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Pain Hyaluronic acid vs. Emollient At baseline, Assessable patients, n = 99 vs. n = 101 >2, n (%): 29 (29.3) vs. 18 (17.8), p = 0.056 At day 7, Assessable patients, n = 96 vs. n = 94 >2, n (%): 31 (32.3) vs. 26 (27.7), p = 0.49 At day 14, Assessable patients, n = 90 vs. n = 86 >2, n (%): 44 (48.9) vs. 30 (34.9), p = 0.06 At day 21, Assessable patients, n = 79 vs. n = 76 >2, n (%): 35 (44.3) vs. 27 (35.5), p = 0.26 At day 28, Assessable patients, n = 72 vs. n = 76 >2, n (%): 26 (36.1) vs. 23 (33.3), p = 0.73
Regarding the other items of the EORTC QLQ-C30 questionnaire, no differences were found between the treatment arms
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Laboratoire Genevrier France provided the hyaluronic acid (Ialuset®) and the simple emollient, and ensured the monitoring of the trial |
2b
two major randomisation criteria were not very well balanced between both treatment arms (median colorimetry of the erythema, and the intensity of pain were significantly higher in patients randomised to receive hyaluronic acid)
"The present study showed no significant difference between hyaluronic acid and simple emollient in the treatment of acute radio-induced dermatitis. There was however a trend towards an improvement in both pain level and skin colorimetry." |