Julie Ryan Wolf1, Jennifer S Gewandter2, Javier Bautista3, Charles E Heckler3, Jon Strasser4, Pawal Dyk5, Thomas Anderson6, Howard Gross7, Tod Speer8, Lindsey Dolohanty9, Kevin Bylund10, Alice P Pentland9, Gary R Morrow3. 1. Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. julie_ryan@urmc.rochester.edu. 2. Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA. 3. URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA. 4. Delaware/Christiana Care NCORP, Newark, DE, USA. 5. Heartland Cancer Research NCORP, St. Louis, MO, USA. 6. Columbus NCORP, Columbus, OH, USA. 7. Dayton Clinical Oncology Program, Dayton, OH, USA. 8. Metro-Minnesota NCORP, St. Louis Park, MN, USA. 9. Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. 10. Department Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA.
Abstract
PURPOSE: Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis. METHODS: This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion. RESULTS: Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT. CONCLUSIONS: Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.
RCT Entities:
PURPOSE: Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis. METHODS: This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancerpatients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion. RESULTS: Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT. CONCLUSIONS: Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.
Entities:
Keywords:
Breast cancer; Pain; Radiation dermatitis; Radiation therapy
Authors: Nicola S Russell; Inge M Krul; Anna M van Eggermond; Berthe M P Aleman; Rosie Cooke; Susanne Kuiper; Steven D Allen; Matthew G Wallis; Damien Llanas; Ibrahima Diallo; Florent de Vathaire; Susan A Smith; Michael Hauptmann; Annegien Broeks; Anthony J Swerdlow; Flora E Van Leeuwen Journal: Clin Transl Radiat Oncol Date: 2017-10-24
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Authors: Carmen Griñan-Lison; Jose L Blaya-Cánovas; Araceli López-Tejada; Marta Ávalos-Moreno; Alba Navarro-Ocón; Francisca E Cara; Adrián González-González; Jose A Lorente; Juan A Marchal; Sergio Granados-Principal Journal: Antioxidants (Basel) Date: 2021-01-31