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Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial

  • Asal RahimiEmail author
  • Osama Mohamad
  • Kevin Albuquerque
  • D.W. Nathan Kim
  • Diana Chen
  • Kimberly Thomas
  • Rachel Wooldridge
  • Aeisha Rivers
  • Marilyn Leitch
  • Roshni Rao
  • Barbara Haley
  • Chul Ahn
  • Dan Garwood
  • Ann Spangler
Original Article
  • 23 Downloads

Abstract

Purpose

We conducted a randomized, double-blind, vehicle-controlled clinical trial to investigate the use of a new proprietary hyaluronan (HA) formulation for the prevention of acute skin toxicity in breast cancer patients undergoing radiotherapy (RT).

Methods

Thirty women with breast cancer undergoing whole breast RT were enrolled. Each patient was randomly assigned to HA formulation (study cream, S) on the medial or lateral half of the irradiated breast and the control cream (placebo, P) on the other half. The primary endpoint was physician’s evaluation of skin symptoms at week 5 during RT and week 2 post-RT. We also collected patients’ independent assessment of skin after RT, patient’s product preference, and an independent physician panel assessment of skin reactions based on photographs.

Results

Twenty-eight patients were evaluable. On physician’s evaluation, there was no significant difference in radiation dermatitis between S and P and no overall preference to either cream at week 5 during or week 2 post-RT. More patients preferred S in evaluating skin appearance and skin reactions, but this did not reach statistical significance. Univariate analysis showed that physicians had an overall preference to the S cream at week 2 post-RT in patients with larger breasts. On the independent panel assessment, 3 reviewers saw no significant difference in radiation toxicity, whereas one reviewer reported better skin outcome with S cream at week 5.

Conclusions

We found a nonstatistically significant patient preference but overall no significant radioprotective effects for this HA formulation compared with placebo except in patients with larger breasts.

Trial registration

The study was registered at www.clinicaltrials.gov (NCT02165605).

Keywords

Breast cancer Radiotherapy Hyaluronic acid Hyaluronan Skin 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

520_2019_4957_Fig1_ESM.png (34 kb)
Online Resource 1

Diagram showing the medial and lateral portions of breasts where placebo or hyaluronan serum was to be applied (PNG 34 kb)

520_2019_4957_MOESM1_ESM.tif (60 kb)
High Resolution Image (TIF 60 kb)
520_2019_4957_MOESM2_ESM.docx (17 kb)
Online Resource 2 (DOCX 16 kb)
520_2019_4957_Fig2_ESM.png (1 mb)
Online Resource 3

Breast skin reactions in two different patients (top panel patient 1; bottom panel patient 2) representing average reactions to treatment at baseline (a, d), week 5 during RT (b, e) and 2 weeks post-RT (c, f) (PNG 1033 kb)

520_2019_4957_MOESM3_ESM.tif (2.9 mb)
High Resolution Image (TIF 2947 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Asal Rahimi
    • 1
    Email author
  • Osama Mohamad
    • 1
  • Kevin Albuquerque
    • 1
  • D.W. Nathan Kim
    • 1
  • Diana Chen
    • 1
  • Kimberly Thomas
    • 1
  • Rachel Wooldridge
    • 2
  • Aeisha Rivers
    • 2
  • Marilyn Leitch
    • 2
  • Roshni Rao
    • 3
  • Barbara Haley
    • 4
  • Chul Ahn
    • 5
  • Dan Garwood
    • 1
  • Ann Spangler
    • 1
  1. 1.Department of Radiation OncologyUniversity of Texas Southwestern Medical CenterDallasUSA
  2. 2.Department of SurgeryUniversity of Texas Southwestern Medical CenterDallasUSA
  3. 3.Department of SurgeryColumbia University Medical CenterNew YorkUSA
  4. 4.Department of Medical OncologyUniversity of Texas Southwestern Medical CenterDallasUSA
  5. 5.Department of Clinical SciencesUniversity of Texas Southwestern Medical CenterDallasUSA

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