Breast Cancer

PV QA 4 - Poster Viewing Q&A 4

TU_11_3431 - Novel Hyaluronan Formulation for Preventing Acute Skin Reactions in Breast During Radiation Therapy: A Randomized Clinical Trial

Tuesday, October 23
2:45 PM - 4:15 PM
Location: Innovation Hub, Exhibit Hall 3

Novel Hyaluronan Formulation for Preventing Acute Skin Reactions in Breast During Radiation Therapy: A Randomized Clinical Trial
O. Mohamad1, A. E. Spangler2, D. N. Kim3, K. Thomas3, K. Albuquerque4, R. Wooldridge2, A. Rivers5, M. Leitch6, R. Rao3, B. Haley3, C. Ahn3, and A. S. Rahimi3; 1University of Texas – Southwestern Medical Center, Department of Radiation Oncology, Dallas, TX, 2UTSW, Dallas, TX, 3University of Texas Southwestern Medical Center, Dallas, TX, 4Department of Radiation Oncology,The University of Texas Southwestern Medical Center, Dallas, TX, 5University of Texas Southwestern, Dallas, TX, 6University of Texas – Southwestern, Dallas, TX

Purpose/Objective(s): Multiple studies have investigated the effects of hyaluronan (HA) for the prevention or management of acute skin reactions during breast radiotherapy (RT) with conflicting results. In this study, we conducted a randomized, double blind, vehicle-controlled clinical trial to investigate the use of a new proprietary HA formulation for the prevention of acute skin toxicity in breast cancer patients undergoing RT. This new formulation of small and large molecular weight HA has high water retention properties and is designed to provide controlled release and slow delivery of various skin moisturizing ingredients including HA.

Materials/Methods: Thirty women with breast cancer undergoing whole breast RT (50.4 Gy with a 10 Gy boost) after lumpectomy were enrolled in this study. Each patient was randomly assigned to the 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 appearance/reactions to RT, patient’s product preference and an independent physician panel assessment of skin reactions based on photographs. Breast size was classified into 3 main categories: small (bra sizes 32A or 32B, 34A or 34B, and 36A), medium (bra sizes 32C, 34C, 36B or 36C, and 38A, 38B, or 38C), or large (larger bra sizes).

Results: Twenty-eight evaluable patients were included in the final analysis. On physician’s evaluation, there was no significant difference in the NCI-CTC radiation dermatitis grades at week 5 during (p=1.00) and week 2 after RT (p=0.43) between S and P. Likewise, skin desquamation was similar between S and P at both time points. Physicians had no overall preference when comparing the study versus placebo creams at week 5 (p=0.41) and week 2 after RT (p=0.80). More patients preferred the study serum in evaluating skin appearance (39 vs 18% at week 5 and 39 vs 22% at week 2 after RT) and skin reactions (46 vs 25% at week 5 and 46 vs 29% at week 2 after RT), but this did not reach statistical significance. Univariate analysis showed that physicians had an overall preference to the S cream at week 2 after RT (p=0.04) in patients with large breasts (compared to small and medium sized breasts).

Conclusion: We found an increase in patient preference but overall no significant radioprotective effects for this HA formulation compared to placebo, however, patients with large breasts may benefit.

Author Disclosure: O. Mohamad: None. A. Spangler: Travel Expenses; ACGME. Chair, Radiation Oncology RRC; ACGME. D. Kim: None. K. Thomas: None. K. Albuquerque: None. R. Wooldridge: None. B. Haley: None. A.S. Rahimi: Employee; Baylor.

Send Email for Osama Mohamad


Assets

TU_11_3431 - Novel Hyaluronan Formulation for Preventing Acute Skin Reactions in Breast During Radiation Therapy: A Randomized Clinical Trial



Attendees who have favorited this

Please enter your access key

The asset you are trying to access is locked. Please enter your access key to unlock.

Send Email for Novel Hyaluronan Formulation for Preventing Acute Skin Reactions in Breast During Radiation Therapy: A Randomized Clinical Trial