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Effects of improved hypoallergenic fabrics in medical wigs in patients with breast cancer with chemotherapy-induced alopecia: a randomised clinical trial
  1. Nao Tamai1,2,
  2. Takeo Minematsu2,3,
  3. Mari Ikeda4,
  4. Yuko Mugita5 and
  5. Hiromi Sanada2,5
  1. 1Department of Imaging Nursing Science, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  2. 2Division of Care Innovation, Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  3. 3Department of Skincare Science, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  4. 4Department of Nursing Administration, School of Nursing, Tokyo Women’s Medical University, Shinjuku-ku, Tokyo, Japan
  5. 5Department of Gerontological Nursing/Wound Care Management, Division of Health Science and Nursing, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
  1. Correspondence to Professor Hiromi Sanada, Division of Care Innovation, Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan; hsanada{at}g.ecc.u-tokyo.ac.jp

Abstract

Purpose Chemotherapy causes changes in appearance in patients with cancer. Therefore, to have a normal life, it is necessary for patients to wear a wig. However, wearing a wig may strain an already sensitive scalp during chemotherapy. This study aimed to assess the effects of a hypoallergenic medical wig in breast cancer patients with chemotherapy-induced alopecia (CIA).

Methods A randomised, single-blind, controlled study was conducted from January 2015 to July 2017 in Tokyo, Japan. Women with non-metastatic breast cancers were enrolled. Participants were provided a hypoallergenic medical wig or a traditional medical wig. The primary endpoint was incidence of scalp dermatitis, including erythema, rash and erosion. The secondary endpoints were incidence of scalp symptoms, alterations in scalp barrier functions and quality of life (QOL). Patients were followed at the start of the first chemotherapy administration and at 13th week.

Results Fifty-nine women were included in the analysis. At 13th week, the incidence of erythema was 44.8% among patients in the intervention group and 86.7% among patients in the control group, in the intention-to-treat analysis (p<0.01). The incidence of erosion tended to decrease in the intervention group at the 13th week (p=0.09). The incidence of scalp symptoms, alterations in scalp barrier functions and QOL were not significantly different between the groups.

Conclusions The incidence of dermatitis, including erythema, rash and erosion, decreased when wearing the new hypoallergenic medical wig. The gentle hypoallergenic medical wig is useful in improving erythema in cancer patients with CIA.

Trial registration number UMIN000021289.

  • breast
  • clinical assessment
  • quality of life
  • skin care
  • supportive care

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Footnotes

  • Contributors NT conceived the research question, designed the study, collected the data, analysed the data, interpreted the data and wrote the manuscript. TM, MI and YM conceived and designed the study, collected the data, analysed the data and wrote the manuscript. HS was responsible for study and protocol design, oversaw the data collection process and consulted on the data analysis protocols, and contributed to the writing of the manuscript.

  • Funding This study was supported by JSPS KAKENHI (grant number JP16K20749).

  • Disclaimer Aderans Co., Ltd. had no role in the study design, data collection, data analysis or manuscript preparation.

  • Competing interests Aderans Co., Ltd. provided the medical wigs containing sericin and traditional medical wigs for the patients.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by each institutional review board, and written informed consent was obtained from all participants prior to study enrolment (#10606-(1), #14-R104).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. The data sets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

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