No proven treatments exist to prevent the radiation-induced skin reactions that are experienced by 95% of cancer patients receiving radiation therapy. Current standard care for radiation dermatitis involves topical products that are prescribed once radiation-induced skin reactions occur, despite the lack of evidence to support the benefit of any such treatments. Although research suggests that topical agents with anti-inflammatory and moisturizing properties may prevent and/or reduce radiation-induced skin reactions, few studies have tested and/or compared the prophylactic effects of topical treatments. For example, both preclinical and clinical studies have shown that increased transepidermal water loss (TEWL) correlates with increased severity of radiation dermatitis. We hypothesize that moisturizing topical interventions with anti-inflammatory properties could reduce radiation dermatitis severity by minimizing TEWL and inflammation during radiation therapy. We propose to conduct a randomized, three-armed, placebo-controlled, blinded clinical pilot trial (N=150) to compare the prophylactic effects of two investigational topical agents, MimyX(R) (0.3% PEA) and Curcumin (4%) gel, versus placebo gel added to the University of Rochester Cancer Center "standard care" on the severity of radiation dermatitis and associated pain. The innovative design of this clinical trial will provide results that show either current "standard care" is the best treatment option or that prophylactic use of another topical intervention is the best option., Additionally, results will determine if a "preventive" approach (i.e., before onset of skin reaction) to clinical care of radiation dermatitis is superior to a "treatment" approach (i.e., after onset of skin reaction). This research proposal incorporates a unique, multidisciplinary team with expertise in the fields of dermatology, radiation oncology, and cancer control. Ultimately, the goal of this study is to identify one or two topical agents for further evaluation in a phase II/III efficacy trial for preventing and/or reducing RT-induced skin reactions and associated pain. Findings from this trial could advance the approach to clinical management of radiation dermatitis, an extremely common toxicity encountered by the majority of patients receiving radiation therapy for cancer.

Public Health Relevance

No proven treatments exist to prevent the radiation-induced skin reactions that are experienced by 95% of cancer patients receiving radiation therapy. Despite the lack of evidence to support the benefit of any treatments, various topical products are often clinically prescribed to patients once radiation-induced skin reactions occur. Few studies have tested the prophylactic effects of topical treatments. This project seeks to compare the effectiveness of two topical products initiated at the beginning of radiation therapy against placebo added to current standard care to reduce the severity of skin reactions and pain experienced by breast cancer patients receiving radiation therapy. This study strives to identify an effective prophylactic topical treatment strategy to reduce radiation-induced skin reactions and pain.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA178648-01A1
Application #
8749597
Study Section
Special Emphasis Panel (ZCA1-RPRB-M (M1))
Program Officer
O'Mara, Ann M
Project Start
2014-09-19
Project End
2016-08-31
Budget Start
2014-09-19
Budget End
2015-08-31
Support Year
1
Fiscal Year
2014
Total Cost
$200,318
Indirect Cost
$69,818
Name
University of Rochester
Department
Dermatology
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627