Abstract
Purpose
Skin toxicity is a common effect from radiotherapy, although difficult to predict on an individual basis, and there is little evidence-based management. This study aimed to quantify inter-patient variation in patient-reported outcome measures for radiation-induced skin reactions (RISR) to enable the determination of the number of patients required for adequate power in a comparative trial of RISR management strategies.
Methods
The study included 154 patients scheduled to receive breast cancer radiotherapy. Patients filled in a weekly questionnaire during and up to 4 weeks following the end of radiotherapy scoring five aspects of their experience of RISR: skin redness, and bother from redness like itching, burning sensation and tenderness/pain.
Results
Assessment of patients’ reported experience of their RISR was shown to be feasible, with 91 % of patients returning at least two questionnaires. The mean score increase between weeks 1 and 4 was 25 points (p value <0.0001, 95 % CI 21–29), and the estimated standard deviation at 4 weeks was 18 (95 % CI 16–21).
Conclusions
Patients’ assessment of their reaction was not predicted on the basis of treatment and patient-related characteristics. Based on the observed variance in scores at 4 weeks, we could calculate the sample size required for a comparative study of two RISR management policies would be 200 patients to have statistical power to detect a clinically significant difference in patient-rated scores of their skin reactions. A trial employing this tool would help provide an evidence base to guide policy in advising patients how to manage their RISR.
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References
Chan RJ, Webster J, Chung B, et al. (2014) Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials. BMC Cancer:14–53
Russell NS, Knaken H, Bruinvis IA, et al. (1994) Quantification of patient to patient variation of skin erythema developing as a response to radiotherapy. Radiother Oncol 30:213–221
Tucker SL, Turesson I, Thames HD (1992) Evidence for individual differences in the radiosensitivity of human skin. Eur J Cancer 28A:1783–1791
Roper B, Kaisig D, Auer F, et al. (2004) Theta-cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care? Strahlenther Onkol 180:315–322
Pignol JP, Olivotto I, Rakovitch E, et al. (2008) A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol 26:2085–2092
http://evs.nci.nih.gov/ftp1/CTCAE/Archive/CTCAE_4.02_2009-09-15_QuickReference_8.5x11.pdf. In.
Fitzpatrick TB (1988) The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol 124:869–871
Krasin MJ, Hoth KA, Hua C, et al. (2009) Incidence and correlates of radiation dermatitis in children and adolescents receiving radiation therapy for the treatment of paediatric sarcomas. Clin Oncol (R Coll Radiol) 21:781–785
Lee TS, Kilbreath SL, Refshauge KM, et al. (2008) Quality of life of women treated with radiotherapy for breast cancer. Support Care Cancer 16:399–405
Back M, Ahern V, Delaney G, et al. (2005) Absence of adverse early quality of life outcomes of radiation therapy in breast conservation therapy for early breast cancer. Australas Radiol 49:39–43
Begg AC, Russell NS, Knaken H, Lebesque JV (1993) Lack of correlation of human fibroblast radiosensitivity in vitro with early skin reactions in patients undergoing radiotherapy. Int J Radiat Biol 64:393–405
Turesson I, Nyman J, Qvarnstrom F, et al. (2010) A low-dose hypersensitive keratinocyte loss in response to fractionated radiotherapy is associated with growth arrest and apoptosis. Radiother Oncol 94:90–101
Freedman GM, Anderson PR, Li J, et al. (2006) Intensity modulated radiation therapy (IMRT) decreases acute skin toxicity for women receiving radiation for breast cancer. Am J Clin Oncol 29:66–70
Harsolia A, Kestin L, Grills I, et al. (2007) Intensity-modulated radiotherapy results in significant decrease in clinical toxicities compared with conventional wedge-based breast radiotherapy. Int J Radiat Oncol Biol Phys 68:1375–1380
Morgan M, McCreedy R, Simpson J, Hay RJ (1997) Dermatology quality of life scales—a measure of the impact of skin diseases. Br J Dermatol 136:202–206
1932;140:1–55. LR. A technique for the measurement of attitudes. Archives of Psychology 1932; 140: 1–55.
Ozolins M, Eady EA, Avery A, et al. (2005) Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne. Health Technol Assess 9:iii–212
Uehara M, Sugiura H, Sakurai K (2001) A trial of oolong tea in the management of recalcitrant atopic dermatitis. Arch Dermatol 137:42–43
Basch E, Iasonos A, McDonough T, et al. (2006) Patient versus clinician symptom reporting using the National Cancer Institute common terminology criteria for adverse events: results of a questionnaire-based study. Lancet Oncol 7:903–909
Acknowledgments
The authors would like to thank Mr. Tony van de Velde for building the database, the nurses at the department of radiotherapy for including and guiding patients in the study, and the patients for taking part.
The study was sponsored and facilitated by the Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, from general research facilities.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (Medical Ethical Review Board of the Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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The authors declare that they have no conflicts of interest .
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Russell, N.S., van Werkhoven, E. & Schagen, S.B. Quantification of patient-reported outcome measures of radiation-induced skin reactions for use in clinical trial design. Support Care Cancer 25, 67–74 (2017). https://doi.org/10.1007/s00520-016-3376-y
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DOI: https://doi.org/10.1007/s00520-016-3376-y