Open Access Open Access  Restricted Access Subscription Access

Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial on the Use of Uncaria tomentosa (Cat's Claw) for Aromatase Inhibitor-Induced Arthralgia: A Pilot Study


Affiliations
1 Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
2 Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, Brazil
 

Introduction: Aromatase inhibitors (AI) are widely used in adjuvant breast cancer treatment, and diffuse articular pain secondary to AI use is the most common cause of treatment discontinuation. Uncaria tomentosa (cat’s claw) has antiinflammatory activity and is used to treat arthrosis and arthritis. Patients and Methods: This prospective, single-center, double-blind, randomized, placebo-controlled phase II study analyzed 70 patients with breast cancer undergoing AI therapy with complaints of arthralgia. The patients received 100 mg of the dry extract of Uncaria tomentosa three times daily for 4 weeks. At the beginning and end of the study, patients answered the Brief Pain Inventory (BPI), Disability Arm, Shoulder, and Hand (DASH), Lequesne, SF-36 Quality of Life questionnaires, completed a visual analog scale (VAS) for pain, and underwent laboratory testing. Results: U. tomentosa was not more effective than the placebo. No evidence of grade 3 or 4 toxicity was found. In addition, no significant differences were seen in laboratory results or inflammatory markers between the two study groups. Conclusion: Dry extract of U. tomentosa was safe but ineffective in reducing AI-induced arthralgia compared with the placebo. Furthermore, the plant extract had no detectable anti-inflammatory activity.

Keywords

Aromatase Inhibitor, Arthralgia, Cat's Claw, Uncaria tomentosa.
Font Size

User

Notifications
JOURNAL COVERS
  

  • Conte P, Frassoldati A. Aromatase inhibitors in the adjuvant treatment of postmenopausal women with early breast cancer: Putting safety issues into perspective. The Breast Journal. 2007 Feb; 13(1): 28–35. https://doi.org/10.1111/j.1524-4741.2006.00359.x PMid:17214790
  • Din OS, Dodwell D, Wakefield RJ, Coleman RE. Aromatase inhibitor-induced arthralgia in early breast cancer: what do we know and how can we find out more? Breast Cancer Research and Treatment. 2010 Apr; 120(3): 525–38. https://doi.org/10.1007/s10549-010-0757-7 PMid:20157776t
  • Aguilar JL, Rojas P, Marcelo A, Plaza A, Bauer R, Reininger E, et al. Anti-inflammatory activity of two different extracts of Uncaria tomentosa (Rubiaceae). Journal of Ethnopharmacology. 2002 Jul; 81(2): 271–6. https://doi.org/10.1016/S0378-8741(02)00093-4
  • Aquino R, De Simone F, Pizza C, Conti C, Stein ML. Plant metabolites. Structure and in vitro antiviral activity of quinovic acid glycosides from Uncaria tomentosa and Guettardaplatypoda. Journal of Natural Products. 1989 Aug; 52(4): 679–85. https://doi.org/10.1021/np50064a002 PMid:2553871
  • Ferreira-Valente MA, Pais Ribeiro JL, Jensen MP. Further Validation of a Portuguese Version of the Brief Pain Inventory Interference Scale. Clinica Salud [Internet]. 2012; 23(1). [Cited 2018 May 15]. Available from: http://www.redalyc.org/resumen.oa?id=180623381005.
  • Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short‐Form McGill Pain Questionnaire (SF‐MPQ), Chronic Pain Grade Scale (CPGS), Short Form‐36 Bodily Pain Scale (SF‐36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) Hawker - 2011 - Arthritis Care and Research - Wiley Online Library [Internet]. [cited 2018 May 15]. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/acr.20543.
  • Marx FC, Oliveira LM de, Bellini CG, Ribeiro MCC. Translation and cultural validation of the Lequesne’s algofunctional questionnaire for osteoarthritis of knee and hip for portuguese language. Revista Brasileira De Reumatologia. 2006 Aug; 46(4): 253–60.
  • Moser AD de L, Knaut LAM, Zotz TG, Scharan KO. Validity and reliability of the portuguese version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form. Revista Brasileira De Reumatologia. 2012 Jun; 52(3): 352–6. https://doi.org/10.1590/S0482-50042012000300005
  • Ciconelli RM, Ferraz MB, Santos W, Meinao I, Quaresma MR. Traducao para a lingua portuguesa e validacao do questionario generico de avaliacao de qualidade de vida SF-36 (Brasil SF-36). Revista Brasileira De Reumatologia. 1999 Jun; 39(3): 143–50.
  • McMillan, Donald C. The systemic inflammation-based Glasgow Prognostic Score: a decade of experience in patients with cancer. Cancer Treatment Reviews. 2013; 39(5): 534–40. https://doi.org/10.1016/j.ctrv.2012.08.003 PMid:22995477
  • Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, et al. Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. International Journal of Radiation Oncology, Biology, Physics. 2000 Apr 1; 47(1): 13–47. https://doi.org/10.1016/S0360-3016(99)00559-3
  • Cutolo M, Villaggio B, Seriolo B, Montagna P, Capellino S, Straub RH, et al. Synovial fluid estrogens in rheumatoid arthritis. Autoimmunity Reviews. 2004 Mar 1; 3(3): 193–8. https://doi.org/10.1016/j.autrev.2003.08.003 PMid:15110231
  • Islander U, Jochems C, Lagerquist MK, Forsblad-d’Elia H, Carlsten H. Estrogens in rheumatoid arthritis; the immune system and bone. Molecular and Cellular Endocrinology. 2011 Mar 15; 335(1): 14–29. https://doi.org/10.1016/j.mce.2010.05.018 PMid:20685609
  • Mur E, Hartig F, Eibl G, Schirmer M. Randomized double blind trial of an extract from the pentacyclic alkaloid-chemotype of Uncaria tomentosa for the treatment of rheumatoid arthritis. The Journal of Rheumatology. 2002 Apr; 29(4): 678–81. PMid:11950006
  • Uncaria tomentosa (cat’s claw) improves quality of life in patients with advanced solid tumors. - PubMed - NCBI [Internet]. [cited 2018 May 13]. Available from: https://www.ncbi.nlm.nih.gov/pubmed/25495394
  • Araujo S, Carmo M do, Farias IL, Gutierres J, Dalmora SL, Flores N, et al. Uncaria tomentosa - Adjuvant Treatment for Breast Cancer: Clinical Trial [Internet]. Evidence-Based Complementary and Alternative Medicine. 2012. [cited 2018 May 13]. Available from: https://www.hindawi.com/journals/ecam/2012/676984/

Abstract Views: 126

PDF Views: 70




  • Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial on the Use of Uncaria tomentosa (Cat's Claw) for Aromatase Inhibitor-Induced Arthralgia: A Pilot Study

Abstract Views: 126  |  PDF Views: 70

Authors

Renan Sordi
Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
Suellen Nastri Castro
Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
Andrea Thaumaturgo Lera
Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
Macilon Nonato Irene
Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
Marilia de Melo Farinazzo
Medical Residents of Clinical Oncology of the Brazilian Institute of Cancer Control, Brazil
Claudia Sette
Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, Brazil
Daniel de Iracema Gomes Cubero
Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, Brazil
Ana Luisa de Castro Baccarin
Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, Brazil
Auro del Giglio
Department of Clinical Oncology, Brazilian Institute of Cancer Control; and Hematology and Oncology Sector, School of Medicine of ABC, Brazil

Abstract


Introduction: Aromatase inhibitors (AI) are widely used in adjuvant breast cancer treatment, and diffuse articular pain secondary to AI use is the most common cause of treatment discontinuation. Uncaria tomentosa (cat’s claw) has antiinflammatory activity and is used to treat arthrosis and arthritis. Patients and Methods: This prospective, single-center, double-blind, randomized, placebo-controlled phase II study analyzed 70 patients with breast cancer undergoing AI therapy with complaints of arthralgia. The patients received 100 mg of the dry extract of Uncaria tomentosa three times daily for 4 weeks. At the beginning and end of the study, patients answered the Brief Pain Inventory (BPI), Disability Arm, Shoulder, and Hand (DASH), Lequesne, SF-36 Quality of Life questionnaires, completed a visual analog scale (VAS) for pain, and underwent laboratory testing. Results: U. tomentosa was not more effective than the placebo. No evidence of grade 3 or 4 toxicity was found. In addition, no significant differences were seen in laboratory results or inflammatory markers between the two study groups. Conclusion: Dry extract of U. tomentosa was safe but ineffective in reducing AI-induced arthralgia compared with the placebo. Furthermore, the plant extract had no detectable anti-inflammatory activity.

Keywords


Aromatase Inhibitor, Arthralgia, Cat's Claw, Uncaria tomentosa.

References





DOI: https://doi.org/10.18311/jnr%2F2019%2F22867