Skip to main content

Advertisement

SpringerLink
Log in

Topical Use of a Silymarin-Based Preparation to Prevent Radiodermatitis

Results of a Prospective Study in Breast Cancer Patients

Prophylaxe und Therapie der Radiodermatitis mit einer silymarinhaltigen Cremeformulierung: Ergebnisse einer prospektiven Untersuchung von Mammakarzinom-Patientinnen

  • Original Article
  • Published:
Strahlentherapie und Onkologie Aims and scope Submit manuscript

Abstract

Purpose:

More than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade 3 lesions. Side effects may reduce the patient’s compliance and can be limiting factors to follow RT protocols. Therefore, there is a high need for more effective prophylactic treatments. In this study, a silymarin-based cream (Leviaderm®) was tested in comparison to our standard of care (SOC) at the involved site.

Methods:

A total of 101 patients were evaluated after breast-conserving surgery followed by RT with 50.4 Gy plus boost 9–16 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50 patients were documented receiving a panthenol-containing cream interventionally, if local skin lesions occurred. The acute skin reactions were classified according to the RTOG and VAS (Visual Analogue Scale) scores.

Results:

The median time to toxicity was prolonged significantly with silymarin-based cream (45 vs. 29 days (SOC), p < 0.0001). Only 9.8% of patients using silymarin-based cream showed grade 2 toxicity in week 5 of RT in comparison to 52% with SOC. At the end of RT, 23.5% of patients in the silymarin-based study group developed no skin reactions vs. 2% with SOC, while grade 3 toxicity occurred only in 2% in the silymarin-based arm compared to 28% (SOC).

Conclusions:

Silymarin-based cream Leviaderm® may be a promising and effective treatment for the prevention of acute skin lesions caused by RT of breast cancer patients. To confirm the results of this nonrandomized, observational trial, this component should be tested in larger multicenter studies in this setting.

Zusammenfassung

Hintergrund:

Im Rahmen einer Strahlentherapie (RT) nach brusterhaltender Operation von Mammakarzinom-Patientinnen stehen die Hautreaktionen im Vordergrund der akuten Nebenwirkungen. Dies kann die Lebensqualität erheblich beeinträchtigen und den Therapieerfolg gefährden. In dieser Untersuchung sollte daher geprüft werden, inwieweit eine prophylaktische Anwendung mit einer silymarinhaltigen Cremeformulierung (Leviaderm®), Hautreaktionen im Vergleich zur Standardpflege reduzieren kann.

Material und Methode:

Ausgewertet wurden insgesamt 101 Mammakarzinom-Patientinnen, die nach einer brusterhaltenden OP mit einer ZVD von 50,4 Gy + Boost 9–16 Gy bestrahlt wurden. Bei 51 Patientinnen wurde eine silymarinhaltige Cremeformulierung prophylaktisch angewendet. Zusätzlich wurden 50 Patientinnen dokumentiert, die gemäß der Standardpflege nur bei Auftreten von Hautreaktionen eine panthenolhaltige Salbe erhielten. Die akuten Hautreaktionen wurden entsprechend den RTOG- und VAS (Visual Analogue Scale) Kriterien klassifiziert.

Ergebnisse:

Unter der silymarinhaltigen Pflegeformulierung kam es signifikant seltener zu Hautnebenwirkungen (mittlere Zeitdauer bis zum Auftreten einer Toxizität 45 Tage vs. 29 Tage im Standardarm, p < 0,0001). In Woche 5 der RT zeigte sich eine G2-Toxizität nur bei 9.8% der Leviaderm®-Patienten (vs 52% im Kontrollarm). 23,5% der Patientinnen, die prophylaktisch eine silymarinhaltige Pflege anwendeten, zeigten bei RT-Ende keine Hautreaktionen gegenüber 2% im Standardarm; G3-Toxizitäten kamen im Verlauf nur in 2% der Fälle unter silymarinhaltiger Lokal-Pflege vor (vs 28% im Kontrollarm).

Schlussfolgerung:

Unsere Daten dieser prospektiven, nicht-randomisierten Untersuchung zeigen, dass die prophylaktische Anwendung einer antioxidativen silymarinhaltigen Cremeformulierung wie Leviaderm® signifikant Schweregrad und Häufigkeit einer Radiodermatitis bei Mammakarzinom-Patientinnen reduzieren kann.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Arangio A, Ivaldi GB, Fodor C et al. Observational PMS comparing best supportive care (BSC) to Leviaderm® in the prophylaxis of radiation induced skin toxicity for women undergoing breast radiation with hyperfractionated scheme after breast conserving surgery. Suppl di Tumori 2006;5:164.

    Google Scholar 

  2. Barone V, Cartia G, D’Emilio V et al. Acute cutaneous side effects in radiotherapy breast cancer treatment. Clinical comparison of two topical products: Leviaderm® with Adelmidrol or Biafin. Suppl di Tumori 2006;5:190.

    Google Scholar 

  3. Bolderston A, Lloyd N, Wong R et al. The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline. Supportive Care Cancer 2006;14:802–817.

    Article  Google Scholar 

  4. Boström 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.

    Article  PubMed  Google Scholar 

  5. Bush DA, Slater JD, Garberoglio C et al. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J 2007;13:114–118.

    Article  PubMed  Google Scholar 

  6. Clarke M, Collins R, Darby S et al. Early Breast Cancer Trialists’rative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005;366:2087–2106.

    PubMed  CAS  Google Scholar 

  7. Cox JD Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys 1995;31:1341–1346.

    Article  PubMed  CAS  Google Scholar 

  8. Dehmlow C, Murawski N, de Groot H. Scavenging of reactive oxygen species and inhibition of arachidonic acid metabolism by silibinin in human cells. Life Sci. 1996;58:1591–1600.

    Article  PubMed  CAS  Google Scholar 

  9. Falkowski S, Trouillas P, Duroux JL et al. Radiodermatitis prevention with sucralfate in breast cancer: fundamental and clinical studies. Support Care Cancer 2011;19:57–65.

    Article  PubMed  Google Scholar 

  10. Fisher B, Anderson S, Bryant J et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 2002;347:1233–1241.

    Article  PubMed  Google Scholar 

  11. Formenti SC, Gidea-Addeo D, Goldberg JD et al. Phase I-II trial of prone accelerated intensity modulated radiation therapy to the breast to optimally spare normal tissue. J Clin Oncol 2007;25:2236–2242.

    Article  PubMed  Google Scholar 

  12. Harsolia A, Kestin L, Grills I et al. Intensity-modulated radiotherapy results in significant decrease in clinical toxicities compared with conventional wedge-based breast radiotherapy. Int J Radiat Oncol Biol Phys 2007;68:1375–1380.

    Article  PubMed  Google Scholar 

  13. Heggie S, Bryant GP, Tripcony L et al. Phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nurs 2002;25:442–451.

    Article  PubMed  Google Scholar 

  14. Herskind C, Wenz F. Radiobiological comparison of hypofractionated accelerated partial breast irradiation (APB!) and single dose intraoperative radiotherapy (IORT) with 50 KV X-rays. Strahlenther Onkol 2010;186:444–451.

    Article  PubMed  Google Scholar 

  15. Calendula IO. In: Blaschek W, Ebel S, Hackenthal E, Holzgrabe U, Keller K, Reichling J, Schulz V (eds) Hagers Enzyklopädie der Arzneistoffe und Drogen. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart 2007;3:546–579.

    Google Scholar 

  16. Jalali R, Malde R, Bhutani R, et al. Prospective evaluation of concomitant tumour bed boost with whole breast irradiation in patients with locally advanced breast cancer undergoing breast-conserving therapy. Breast 2008;17:64–70.

    Article  PubMed  Google Scholar 

  17. Lambert DM Vandevoorde S, Jonsson KO et al. The palmitoylethanolamide family: a new class of anti inflammatory agents Current Medicinal Chemistry 2002;9:663–674.

    PubMed  CAS  Google Scholar 

  18. Lehmacher W. Multiple testing with two groups of repeated measures. In: Vollmar J (ed) Biometrie in der chemisch-pharmazeutischen Industrie Band 6. Gustav Fischer Verlag, Stuttgart 1995;27–40.

    Google Scholar 

  19. López E, Núñez MI, Guerrero MR et al. Breast cancer acute radiotherapy morbidity evaluated by different scoring systems. Breast Canc Res Treat 2002;73:127–134.

    Article  Google Scholar 

  20. Mansour HH, Hafez HF, Fahmy NM. Silymarin modulates cisplatin-induced oxidative stress and hepatotoxicity in rats. J Biochem Mol Biol 2006;39:656–661.

    Article  PubMed  CAS  Google Scholar 

  21. Moran MS, Haffty BG. Radiation techniques and toxicities for locally advanced breast cancer. Semin Radiat Oncol 2009;19:244–255.

    Article  PubMed  Google Scholar 

  22. Olsen DL, Raub W Jr, Bradley C et al. The effect of aloe vera gel/mild soap versus mild soap alone in preventing skin reactions in patients undergoing radiation therapy. Oncol Nurs Forum 2001;28(3):543–547.

    PubMed  CAS  Google Scholar 

  23. Pignol J, Olivotto I, Rakovitch E et al. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol 2008;26:2085–2092.

    Article  PubMed  Google Scholar 

  24. Pires AM, Segreto RA, Segreto HR. RTOG criteria to evaluate acute skin reaction and risk fFactors in patients with breast cancer submitted to radiotherapy. Rev Lat Am Enfermagem 2008;16:844–849.

    Article  PubMed  Google Scholar 

  25. Polgar C, Strnad V, Kovacs G. Partial-breast irradiation or whole-breast radiotherapy for early breast cancer: a meta-analysis of randomized trials. Strahlenther Onkol 2010;186:113–114.

    Article  PubMed  Google Scholar 

  26. Pommier P, Gomez F, Sunyach MP et al. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol 2004;22:1447–1453.

    Article  PubMed  CAS  Google Scholar 

  27. Porock D, Kristjanson L. Skin reactions during chemotherapy for breast cancer: the use and impact of topical agents and dressing. Eur J Cancer Care 1999;8:143–153.

    Article  CAS  Google Scholar 

  28. Pulvirenti N, Nasca MR, Micali G. Topical Adelmidrol 2% emulsion, a novel aliamide, in the treatment of mild atopic dermatitis in pediatric subjects: a pilot study. Acta Dermatovenerol Croat 2007;15:80–83.

    PubMed  CAS  Google Scholar 

  29. Röper B, Kaisig D, Auer F et al. Thêta-Cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care Strahlenther Onkol 2004;180:315–322.

    Article  PubMed  Google Scholar 

  30. Roy I, Fortin A, Larochelle M. The impact of skin washing with water and soap during breast irradiation. A randomized study. Radiother Oncol 2001;58:333–339.

    Article  CAS  Google Scholar 

  31. Saller R, Melzer J, Reichling J et al. An updated systematic review of the pharmacology of silymarin. Forsch Komplementärmed 2007;14:70–80.

    Article  Google Scholar 

  32. Sauer R, Budach W, Dunst J et al. Leitlinien in der Radioonkologie. Leitlinie Radiotherapie des Mammakarzinoms. Strahlenther Onkol 2006;182:17–18.

    Article  Google Scholar 

  33. Shukla PN, M Gairola, BK Mohanti et al. Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: a prospective randomized study. Indian J Cancer 2006;43:180–184.

    Article  PubMed  CAS  Google Scholar 

  34. Valenzuela A, Monica A, Soledad V et al. Selectivity of silymarin on the increase of the glutathione content in different tissues of the rat. Planta Med 1989;55:420–422.

    Article  PubMed  CAS  Google Scholar 

  35. Victorrajmohan C, Pradeep K, Karthikeyan S. Influence of silymarin administration on hepatic glutathione-conjugating enzyme system in rats treated with antitubercular drugs. Drugs R D 2006;6:395–400.

    Article  Google Scholar 

  36. Voigtmann K, Köllner V, Einsle F et al. Emotional state of patients in radiotherapy and how they deal with their disorder. Strahlenther Onkol 2010;186:229–235.

    Article  PubMed  Google Scholar 

  37. Wewers ME, Lowe NK. A critical review of Visual Analogue Scales in the measurement of clinical phenomena. Research in Nursing and Health 1990;13:227–236.

    Article  PubMed  CAS  Google Scholar 

  38. Zimmermann J, Budach W, Dörr W. Individual skin care during radiotherapy. Strahlenther Onkol 1998;174:74–77.

    PubMed  Google Scholar 

  39. Zurl B, Stranzl H, Winkler P et al. Quantitative assessment of irradiated lung volume and lung mass in breast cancer patients treated with tangential fields in combination with deep inspiration breath hold (DIBH). Strahlenther Onkol 2010;186:157–162.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Klinik für Radioonkologie und Strahlentherapie, Klinikum Braunschweig, Braunschweig, Germany

    Martina Becker-Schiebe & Wolfgang Hoffmann

  2. Research & Development, Rottapharm/Madaus, Cologne, Germany

    Ulrich Mengs & Margitta Schaefer

  3. CRM Biometrics GmbH, Rheinbach, Germany

    Michael Bulitta

  4. Klinik für Radioonkologie und Strahlentherapie, Städt. Klinikum Braunschweig gGmbH, Celler Straße 38, 38114, Braunschweig, Germany

    Martina Becker-Schiebe

Authors
  1. Martina Becker-Schiebe
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ulrich Mengs
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Margitta Schaefer
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Michael Bulitta
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Wolfgang Hoffmann
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Martina Becker-Schiebe.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Becker-Schiebe, M., Mengs, U., Schaefer, M. et al. Topical Use of a Silymarin-Based Preparation to Prevent Radiodermatitis. Strahlenther Onkol 187, 485–491 (2011). https://doi.org/10.1007/s00066-011-2204-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00066-011-2204-z

Key Words

Schlüsselwörter

Search

Navigation