Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4

International Journal of Radiation Oncology Biology Physics

Volumn 79, Issue 5, 2011, Pages 1460-1466

  Miller, Robert C ^a   Schwartz, David J ^b   Sloan, Jeff A ^a   Griffin, Patricia C ^c   Deming, Richard L ^d   Anders, Jon C ^e   Stoffel, Thomas J ^f   Haselow, Robert E ^h   Schaefer, Paul L ^g   Bearden III, James D ^c   Atherton, Pamela J ^a   Loprinzi, Charles L ^a   Martenson, James A ^a  

^a MAYO CLINIC   (United States)

^b Minneapolis Radiation Oncology   (United States)

^c Upstate Carolina Community Clinical Oncology Program   (United States)

^d Iowa Oncology Research Association Community Clinical Oncology Program   (United States)

^e WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

^f Cedar Rapids Oncology Project CCOP   (United States)

^g Toledo Community Hospital Oncology Program   (United States)

^h Metro Minnesota Community Clinical Oncology Program   (United States)

Author keywords

Breast neoplasms; Mometasone furoate; Radiotherapy; Skin manifestations; Toxicity

Indexed keywords

ADVERSE EVENTS; BREAST CANCER; BREAST CARCINOMAS; BREAST NEOPLASM; CANCER TREATMENT; CHEST WALL; COMMON TERMINOLOGY CRITERIA; DUCTAL CARCINOMA IN SITU; EXTERNAL BEAM RADIOTHERAPY; MAXIMUM GRADE; MOMETASONE FUROATE; PATIENT-REPORTED OUTCOMES; PLACEBO GROUPS; QUALITY-OF-LIFE; RANDOMIZED TRIAL; SELF-ASSESSMENT; SKIN TOXICITY;

DISEASES; RATING; TERMINOLOGY; TOXICITY; TUMORS;

RADIOTHERAPY;

DERMABASE; MOMETASONE FUROATE; PLACEBO; UNCLASSIFIED DRUG;

ACUTE TOXICITY; ADULT; ARTICLE; BREAST CARCINOMA; BURNING SENSATION; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CARCINOMA IN SITU; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; EXTERNAL BEAM RADIOTHERAPY; FEMALE; HUMAN; INTRADUCTAL CARCINOMA; INVASIVE CARCINOMA; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RADIATION DERMATITIS; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SKIN IRRITATION; SKIN TOXICITY; THORAX WALL CANCER;

ACUTE DISEASE; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS; BREAST NEOPLASMS; CARCINOMA IN SITU; CARCINOMA, DUCTAL, BREAST; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MIDDLE AGED; PREGNADIENEDIOLS; PRURITUS; RADIODERMATITIS;

EID: 79952709171     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2010.01.031     Document Type: Article

References (32)

1. Hopewell JW. The skin: Its structure and response to ionizing radiation. Int J Radiat Biol 1990;57:751-773. (Pubitemid 20115272)
2. Bostrom A, Lindman H, Swartling C, et al. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: Results from a double-blind, randomized study. Radiother Oncol 2001;59:257-265. (Pubitemid 32429573)
3. Fisher J, Scott C, Stevens R, et al. Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys 2000;48:1307-1310.
4. Wells M, Macmillan M, Raab G, et al. Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomised controlled trial. Radiother Oncol 2004;73:153-162. (Pubitemid 39470154)
5. Wickline MM. Prevention and treatment of acute radiation dermatitis: A literature review. Oncol Nurs Forum 2004;31:237-247.
6. Williams MS, Burk M, Loprinzi CL, et al. Phase III doubleblind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity. Int J Radiat Oncol Biol Phys 1996;36:345-349. (Pubitemid 26359459)
7. Cancer Therapy Evaluation Program [Internet]. Rockville, MD: National Cancer Institute [cited 2009 Feb 4]. CommonTerminology Criteria for Adverse Events v3.0 (CTCAE); 2006 Aug 9 [cited 2009 Feb 4]. Available from: www.ctep.cancer.gov/ protocolDevelopment/electronic-applications/docs/ctcaev3. pdf. Accessed November 20, 2008.
8. Chren MM, Lasek RJ, Sahay AP, et al. Measurement properties of Skindex-16: A brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg 2001;5:105-110. (Pubitemid 32588315)
9. Berthelet E, Truong PT, Musso K, et al. Preliminary reliability and validity testing of a new Skin Toxicity Assessment Tool (STAT) in breast cancer patients undergoing radiotherapy. Am J Clin Oncol 2004;27:626-631. (Pubitemid 39603279)
10. Bretscher M, Rummans T, Sloan J, et al. Quality of life in hospice patients: A pilot study. Psychosomatics 1999;40:309-313. (Pubitemid 29315951)
11. Grunberg SM, Groshen S, Steingass S, et al. Comparison of conditional quality of life terminology and visual analogue scale measurements. Qual Life Res 1996;5:65-72. (Pubitemid 26100504)
12. Gudex C, Dolan P, Kind P, et al. Health state valuations from the general public using the visual analogue scale. Qual Life Res 1996;5:521-531. (Pubitemid 27006964)
13. Hyland ME, Sodergren SC. Development of a new type of global quality of life scale, and comparison of performance and preference for 12 global scales. Qual Life Res 1996;5:469-480. (Pubitemid 26382281)
14. Freedman GM, Anderson PR, Li J, et al. Intensity modulated radiation therapy (IMRT) decreases acute skin toxicity for women receiving radiation for breast cancer. Am J Clin Oncol 2006;29:66-70. (Pubitemid 44356718)
15. Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys 1995;31:1171-1185.
16. Boisnic S, Branchet-Gumila MC, Nizri D, et al. Histochemical and biochemical modifications induced by experimental irradiation of human skin maintained in survival conditions and modulation by application of an emulsion containing trolamine. Int J Tissue React 2003;25:9-18. (Pubitemid 36813943)
17. Cronstein BN, Kimmel SC, Levin RI, et al. A mechanism for the antiinflammatory effects of corticosteroids: the glucocorticoid receptor regulates leukocyte adhesion to endothelial cells and expression of endothelial-leukocyte adhesion molecule 1 and intercellular adhesion molecule 1. Proc Natl Acad Sci USA 1992;89:9991-9995.
18. Halperin EC, Gaspar L, George S, et al., for the CNS Cancer Consortium. A double-blind, randomized, prospective trial to evaluate topical vitamin C solution for the prevention of radiation dermatitis. Int J Radiat Oncol Biol Phys 1993;26:413-416. (Pubitemid 23182335)
19. Heggie S, Bryant GP, Tripcony L, et al. A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nurs 2002;25:442-451. (Pubitemid 35424054)
20. Liguori V, Guillemin C, Pesce GF, et al. Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy. Radiother Oncol 1997;42:155-161. (Pubitemid 27132744)
21. Lokkevik E, Skovlund E, Reitan JB, et al. Skin treatment with bepanthen cream versus no cream during radiotherapy: A randomized controlled trial. Acta Oncol 1996;35:1021-1026.
22. Vuong T, Franco E, Lehnert S, et al. Silver leaf nylon dressing to prevent radiation dermatitis in patients undergoing chemotherapy and external beam radiotherapy to the perineum. Int J Radiat Oncol Biol Phys 2004;59:809-814. (Pubitemid 38748746)
23. Marshall AH. The action cortisone on experimental acute roentgen dermatitis. Acta Radiol 1953;39:73-77.
24. Scott A, Kalz F. The effect of the topical application of corticotrophin, hydrocortisone, and fluorocortisone on the process of cutaneous inflammation. J Invest Dermatol 1956;26:361-378.
25. Bjornberg A, Hellgren L, Olsson S. Treatment of radiation dermatitis with fluocinolone acetonide. Acta Radiol Ther Phys Biol 1965;3:129-134.
26. Bjornberg A, Hellgren L, Magnusson B, et al. Topical treatment of radiation dermatitis with bethamethasone-17-valerate, Vaseline and Eucerine: A double-blind comparison. Clin Radiol 1967;18:463-464.
27. Glees JP, Mameghan-Zadeh H, Sparkes CG. Effectiveness of topical steroids in the control of radiation dermatitis: A randomised trial using 1% hydrocortisone cream and 0.05% clobetasone butyrate (Eumovate). Clin Radiol 1979;30:397-403. (Pubitemid 9207923)
28. Huter KA, Muller HG. [Radiation reaction of the skin in the use of glucocorticoids (German).]. Strahlentherapie 1959;108: 475-477.
29. Potera ME, Lookingbill DP, Stryker JA. Prophylaxis of radiation dermatitis with a topical cortisone cream. Radiology 1982;143:775-777. (Pubitemid 12129333)
30. Schmuth M, Wimmer MA, Hofer S, et al. Topical corticosteroid therapy for acute radiation dermatitis: A prospective, randomized, double-blind study. Br J Dermatol 2002;146:983-991. (Pubitemid 34779478)
31. Sloan JA, Berk L, Roscoe J, et al., for the National Cancer Institute. Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. J Clin Oncol 2007;25:5070-5077. (Pubitemid 350232285)
32. Trotti A, Colevas AD, Setser A, et al. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol 2007;25:5121-5127. (Pubitemid 350232293)