Julie Ryan Wolf1,2,3, Charles E Heckler4,5, Joseph J Guido4,5, Anita R Peoples4, Jennifer S Gewandter6, Marilyn Ling7, Vincent P Vinciguerra8, Thomas Anderson9, Lisa Evans10, James Wade11, Alice P Pentland12, Gary R Morrow4,5. 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 Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA. julie_ryan@urmc.rochester.edu. 3. URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA. julie_ryan@urmc.rochester.edu. 4. URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA. 5. Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA. 6. Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA. 7. Department of Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA. 8. North Shore-LIJ Cancer Institute, New Hyde Park, NY, USA. 9. Columbus NCORP, Columbus, OH, USA. 10. Southeast Clinical Oncology Research Consortium, Winston-Salem, NC, USA. 11. Heartland NCORP, Decatur, IL, USA. 12. Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.
Abstract
PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancer patients. Patients took four 500-mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until 1 week post-RT. RESULTS:A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed-model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) = 0.044 (- 0.101, 0.188), p = 0.552). Fewer curcumin patients with RDS > 3.0 suggested a trend toward reduced severity (7.4 vs. 12.9%, p = 0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS:Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.
RCT Entities:
PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancerpatients. Patients took four 500-mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until 1 week post-RT. RESULTS: A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed-model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) = 0.044 (- 0.101, 0.188), p = 0.552). Fewer curcuminpatients with RDS > 3.0 suggested a trend toward reduced severity (7.4 vs. 12.9%, p = 0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS: Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.
Authors: C Robertson; A G Robertson; J H Hendry; S A Roberts; N J Slevin; W B Duncan; R H MacDougall; G R Kerr; B O'Sullivan; T J Keane Journal: Int J Radiat Oncol Biol Phys Date: 1998-01-15 Impact factor: 7.038
Authors: M Schmuth; M A Wimmer; S Hofer; A Sztankay; G Weinlich; D M Linder; P M Elias; P O Fritsch; E Fritsch Journal: Br J Dermatol Date: 2002-06 Impact factor: 9.302
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Authors: Julie Ryan Wolf; Jennifer S Gewandter; Javier Bautista; Charles E Heckler; Jon Strasser; Pawal Dyk; Thomas Anderson; Howard Gross; Tod Speer; Lindsey Dolohanty; Kevin Bylund; Alice P Pentland; Gary R Morrow Journal: Support Care Cancer Date: 2019-11-22 Impact factor: 3.603
Authors: Anita R Peoples; Wilfred R Pigeon; Dongmei Li; Sheila N Garland; Michael L Perlis; Julia E Inglis; Vincent Vinciguerra; Thomas Anderson; Lisa S Evans; James L Wade; Deborah J Ossip; Gary R Morrow; Julie Ryan Wolf Journal: J Pain Symptom Manage Date: 2020-08-05 Impact factor: 3.612
Authors: María Ángeles Ávila-Gálvez; Juan Antonio Giménez-Bastida; Juan Carlos Espín; Antonio González-Sarrías Journal: Int J Mol Sci Date: 2020-08-10 Impact factor: 5.923