drugset / Trial / NCT05308732
Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
NaSequentialOpen-labelPrevention
Summary
This study aims to propose an alternative and auxiliary methodology for the prevention and treatment of Oral Mucositis (OM) in patients undergoing radiotherapy or radio and chemotherapy for head and neck neoplasms through the use of copaiba-based mouthwash, since the treatment that currently has proven efficacy for the prevention of OM(Low Power Laser Therapy) cannot be applied in tumor regions due to the risk of stimulating the tissue proliferation of malignant cells.
Timeline
- Start
- 2021-05-11
- Primary completion
- 2025-09-07
- Completion
- 2026-12
Publications
- Background Addy M. Oral hygiene products: potential for harm to oral and systemic health? Periodontol 2000. 2008;48:54-65. doi: 10.1111/j.1600-0757.2008.00253.x. No abstract available.
- Background Ames-Sibin AP, Barizao CL, Castro-Ghizoni CV, Silva FMS, Sa-Nakanishi AB, Bracht L, Bersani-Amado CA, Marcal-Natali MR, Bracht A, Comar JF. beta-Caryophyllene, the major constituent of copaiba oil, reduces systemic inflammation and oxidative stress in arthritic rats. J Cell Biochem. 2018 Dec;119(12):10262-10277. doi: 10.1002/jcb.27369. Epub 2018 Aug 21.
- Background Antunes HS, Herchenhorn D, Small IA, Araujo CM, Viegas CM, Cabral E, Rampini MP, Rodrigues PC, Silva TG, Ferreira EM, Dias FL, Ferreira CG. Phase III trial of low-level laser therapy to prevent oral mucositis in head and neck cancer patients treated with concurrent chemoradiation. Radiother Oncol. 2013 Nov;109(2):297-302. doi: 10.1016/j.radonc.2013.08.010. Epub 2013 Sep 14.
- Background Antunes HS, de Azevedo AM, da Silva Bouzas LF, Adao CA, Pinheiro CT, Mayhe R, Pinheiro LH, Azevedo R, D'Aiuto de Matos V, Rodrigues PC, Small IA, Zangaro RA, Ferreira CG. Low-power laser in the prevention of induced oral mucositis in bone marrow transplantation patients: a randomized trial. Blood. 2007 Mar 1;109(5):2250-5. doi: 10.1182/blood-2006-07-035022. Epub 2006 Oct 19.
- Background Antunes HS, Ferreira EM, de Faria LM, Schirmer M, Rodrigues PC, Small IA, Colares M, Bouzas LF, Ferreira CG. Streptococcal bacteraemia in patients submitted to hematopoietic stem cell transplantation: the role of tooth brushing and use of chlorhexidine. Med Oral Patol Oral Cir Bucal. 2010 Mar 1;15(2):e303-9. doi: 10.4317/medoral.15.e303.
- Background Ariyawardana A, Cheng KKF, Kandwal A, Tilly V, Al-Azri AR, Galiti D, Chiang K, Vaddi A, Ranna V, Nicolatou-Galitis O, Lalla RV, Bossi P, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3985-3995. doi: 10.1007/s00520-019-04888-w. Epub 2019 Jul 8.
- Background Bensadoun RJ, Franquin JC, Ciais G, Darcourt V, Schubert MM, Viot M, Dejou J, Tardieu C, Benezery K, Nguyen TD, Laudoyer Y, Dassonville O, Poissonnet G, Vallicioni J, Thyss A, Hamdi M, Chauvel P, Demard F. Low-energy He/Ne laser in the prevention of radiation-induced mucositis. A multicenter phase III randomized study in patients with head and neck cancer. Support Care Cancer. 1999 Jul;7(4):244-52. doi: 10.1007/s005200050256.
- Background Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background Cohen N, Fedewa S, Chen AY. Epidemiology and Demographics of the Head and Neck Cancer Population. Oral Maxillofac Surg Clin North Am. 2018 Nov;30(4):381-395. doi: 10.1016/j.coms.2018.06.001. Epub 2018 Aug 3.
- Background Dalenogare DP, Ferro PR, De Pra SDT, Rigo FK, de David Antoniazzi CT, de Almeida AS, Damiani AP, Strapazzon G, de Oliveira Sardinha TT, Galvani NC, Boligon AA, de Andrade VM, da Silva Brum E, Oliveira SM, Trevisan G. Antinociceptive activity of Copaifera officinalis Jacq. L oil and kaurenoic acid in mice. Inflammopharmacology. 2019 Aug;27(4):829-844. doi: 10.1007/s10787-019-00588-3. Epub 2019 May 16.
- Background Dias-da-Silva MA, Pereira AC, Marin MC, Salgado MA. The influence of topic and systemic administration of copaiba oil on the alveolar wound healing after tooth extraction in rats. J Clin Exp Dent. 2013 Oct 1;5(4):e169-73. doi: 10.4317/jced.51104. eCollection 2013 Oct 1.
- Background Diefenbach AL, Muniz FWMG, Oballe HJR, Rosing CK. Antimicrobial activity of copaiba oil (Copaifera ssp.) on oral pathogens: Systematic review. Phytother Res. 2018 Apr;32(4):586-596. doi: 10.1002/ptr.5992. Epub 2017 Nov 29.
- Background Estevao LR, Medeiros JP, Baratella-Evencio L, Simoes RS, Mendonca Fde S, Evencio-Neto J. Effects of the topical administration of copaiba oil ointment (Copaifera langsdorffii) in skin flaps viability of rats. Acta Cir Bras. 2013 Dec;28(12):863-9. doi: 10.1590/s0102-86502013001200009.
- Background Fidler P, Loprinzi CL, O'Fallon JR, Leitch JM, Lee JK, Hayes DL, Novotny P, Clemens-Schutjer D, Bartel J, Michalak JC. Prospective evaluation of a chamomile mouthwash for prevention of 5-FU-induced oral mucositis. Cancer. 1996 Feb 1;77(3):522-5. doi: 10.1002/(SICI)1097-0142(19960201)77:33.0.CO;2-6.
- Background Gelmini F, Beretta G, Anselmi C, Centini M, Magni P, Ruscica M, Cavalchini A, Maffei Facino R. GC-MS profiling of the phytochemical constituents of the oleoresin from Copaifera langsdorffii Desf. and a preliminary in vivo evaluation of its antipsoriatic effect. Int J Pharm. 2013 Jan 20;440(2):170-8. doi: 10.1016/j.ijpharm.2012.08.021. Epub 2012 Aug 20.
- Background Gomes Nde M, de Rezende CM, Fontes SP, Matheus ME, Pinto Ada C, Fernandes PD. Characterization of the antinociceptive and anti-inflammatory activities of fractions obtained from Copaifera multijuga Hayne. J Ethnopharmacol. 2010 Mar 2;128(1):177-83. doi: 10.1016/j.jep.2010.01.005. Epub 2010 Jan 12.
- Background Gooi Z, Fakhry C, Goldenberg D, Richmon J, Kiess AP; Education Committee of the American Head and Neck Society (AHNS). AHNS Series: Do you know your guidelines?Principles of radiation therapy for head and neck cancer: A review of the National Comprehensive Cancer Network guidelines. Head Neck. 2016 Jul;38(7):987-92. doi: 10.1002/hed.24448. Epub 2016 Mar 25.
- Background GUTKNECHT, N.; EDUARDO, C. P. A odontologia e o laser. Primeira e ed. [s.l.]: Berlin: Quintessence, 2004. 25-60 p.
- Background INCA. Estimativa 2020: incidêcia de câncer no Brasil. [s.l.]: Instituto Nacional de Câncer José Alencar Gomes da Silva/ Ministério da Saúde, 2019. ISBN: 9788573183887.
- Background Jones JA, Avritscher EB, Cooksley CD, Michelet M, Bekele BN, Elting LS. Epidemiology of treatment-associated mucosal injury after treatment with newer regimens for lymphoma, breast, lung, or colorectal cancer. Support Care Cancer. 2006 Jun;14(6):505-15. doi: 10.1007/s00520-006-0055-4. Epub 2006 Apr 7.
- Background Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, McGuire DB, Migliorati C, Nicolatou-Galitis O, Peterson DE, Raber-Durlacher JE, Sonis ST, Elad S; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014 May 15;120(10):1453-61. doi: 10.1002/cncr.28592. Epub 2014 Feb 25.
- Background Leandro LM, Vargas Fde S, Barbosa PC, Neves JK, da Silva JA, da Veiga-Junior VF. Chemistry and biological activities of terpenoids from copaiba (Copaifera spp.) oleoresins. Molecules. 2012 Mar 30;17(4):3866-89. doi: 10.3390/molecules17043866.
- Background Lima CS, de Medeiros BJ, Favacho HA, dos Santos KC, de Oliveira BR, Taglialegna JC, da Costa EV, de Campos KJ, Carvalho JC. Pre-clinical validation of a vaginal cream containing copaiba oil (reproductive toxicology study). Phytomedicine. 2011 Sep 15;18(12):1013-23. doi: 10.1016/j.phymed.2011.05.004. Epub 2011 Jun 12.
- Background Lydiatt WM, Patel SG, O'Sullivan B, Brandwein MS, Ridge JA, Migliacci JC, Loomis AM, Shah JP. Head and Neck cancers-major changes in the American Joint Committee on cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017 Mar;67(2):122-137. doi: 10.3322/caac.21389. Epub 2017 Jan 27.
- Background Marur S, Forastiere AA. Head and Neck Squamous Cell Carcinoma: Update on Epidemiology, Diagnosis, and Treatment. Mayo Clin Proc. 2016 Mar;91(3):386-96. doi: 10.1016/j.mayocp.2015.12.017.
- Background Mazokopakis EE, Vrentzos GE, Papadakis JA, Babalis DE, Ganotakis ES. Wild chamomile (Matricaria recutita L.) mouthwashes in methotrexate-induced oral mucositis. Phytomedicine. 2005 Jan;12(1-2):25-7. doi: 10.1016/j.phymed.2003.11.003.
- Background MENEZES, A. C. et al. Abordagem clínica e terapêutica da mucosite oral induzida por radioterapia e quimioterapia em pacientes com câncer. Revistas, [s.l.], v. 71, no 1, p. 35, 2014. ISSN: 0034-7272, DOI: 10.18363/rbo.v71i1.536.
- Background Mifsud M, Eskander A, Irish J, Gullane P, Gilbert R, Brown D, de Almeida JR, Urbach DR, Goldstein DP. Evolving trends in head and neck cancer epidemiology: Ontario, Canada 1993-2010. Head Neck. 2017 Sep;39(9):1770-1778. doi: 10.1002/hed.24829. Epub 2017 May 30.
- Background Migliorati C, Hewson I, Lalla RV, Antunes HS, Estilo CL, Hodgson B, Lopes NN, Schubert MM, Bowen J, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of laser and other light therapy for the management of oral mucositis in cancer patients. Support Care Cancer. 2013 Jan;21(1):333-41. doi: 10.1007/s00520-012-1605-6. Epub 2012 Sep 22.
- Background NEVILLE, B. W. et al. Patologia Oral e Maxilofacial. Terceira E ed. Rio de Janeiro: Elsevier, 2012. ISBN: 9788535230895.
- Background Pfeifer Barbosa AL, Wenzel-Storjohann A, Barbosa JD, Zidorn C, Peifer C, Tasdemir D, Cicek SS. Antimicrobial and cytotoxic effects of the Copaifera reticulata oleoresin and its main diterpene acids. J Ethnopharmacol. 2019 Apr 6;233:94-100. doi: 10.1016/j.jep.2018.11.029. Epub 2018 Nov 23.
- Background PIERI, F. A.; MUSSI, M. C.; MOREIRA, M. A. S. Óleo de copaíba (Copaifera sp.): Histórico, extração, aplicações industrials e propriedades medicinais. Revista Brasileira de Plantas Medicinais, [s.l.], v. 11, no 4, p. 465-472, 2009. ISSN: 15160572, DOI: 10.1590/s1516-05722009000400016.
- Background Pieri FA, Mussi MC, Fiorini JE, Moreira MA, Schneedorf JM. Bacteriostatic effect of copaiba oil (Copaifera officinalis) against Streptococcus mutans. Braz Dent J. 2012;23(1):36-8. doi: 10.1590/s0103-64402012000100006.
- Background Pinna R, Campus G, Cumbo E, Mura I, Milia E. Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage. Ther Clin Risk Manag. 2015 Feb 4;11:171-88. doi: 10.2147/TCRM.S70652. eCollection 2015.
- Background Rettig EM, D'Souza G. Epidemiology of head and neck cancer. Surg Oncol Clin N Am. 2015 Jul;24(3):379-96. doi: 10.1016/j.soc.2015.03.001. Epub 2015 Apr 9.
- Background Ricardo LM, Dias BM, Mugge FLB, Leite VV, Brandao MGL. Evidence of traditionality of Brazilian medicinal plants: The case studies of Stryphnodendron adstringens (Mart.) Coville (barbatimao) barks and Copaifera spp. (copaiba) oleoresin in wound healing. J Ethnopharmacol. 2018 Jun 12;219:319-336. doi: 10.1016/j.jep.2018.02.042. Epub 2018 Mar 2.
- Background Sahebjamee M, Mansourian A, Hajimirzamohammad M, Zadeh MT, Bekhradi R, Kazemian A, Manifar S, Ashnagar S, Doroudgar K. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial. Oral Health Prev Dent. 2015;13(4):309-15. doi: 10.3290/j.ohpd.a33091.
- Background SCHIRMER, E. M.; FERRARI, A.; TRINDADE, L. C. T. Evolução da mucosite oral após intervenção nutricional em pacientes oncológicos no serviço de cuidados paliativos. Revista Dor, [s.l.], v. 13, no 2, p. 141-146, 2012. ISSN: 2317-6393, DOI: 10.1590/s1806-00132012000200009.
- Background Scully C, Epstein J, Sonis S. Oral mucositis: a challenging complication of radiotherapy, chemotherapy, and radiochemotherapy. Part 2: diagnosis and management of mucositis. Head Neck. 2004 Jan;26(1):77-84. doi: 10.1002/hed.10326.
- Background Simoes CA, Conde NC, Venancio GN, Milerio PS, Bandeira MF, da Veiga Junior VF. Antibacterial Activity of Copaiba Oil Gel on Dental Biofilm. Open Dent J. 2016 May 11;10:188-95. doi: 10.2174/1874210601610010188. eCollection 2016.
- Background Sonis ST, Eilers JP, Epstein JB, LeVeque FG, Liggett WH Jr, Mulagha MT, Peterson DE, Rose AH, Schubert MM, Spijkervet FK, Wittes JP. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Mucositis Study Group. Cancer. 1999 May 15;85(10):2103-13. doi: 10.1002/(sici)1097-0142(19990515)85:103.0.co;2-0.
- Background Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
- Background Sonis ST. Mucositis: The impact, biology and therapeutic opportunities of oral mucositis. Oral Oncol. 2009 Dec;45(12):1015-20. doi: 10.1016/j.oraloncology.2009.08.006. Epub 2009 Oct 13.
- Background Sroussi HY, Jessri M, Epstein J. Oral Assessment and Management of the Patient with Head and Neck Cancer. Oral Maxillofac Surg Clin North Am. 2018 Nov;30(4):445-458. doi: 10.1016/j.coms.2018.06.006. Epub 2018 Aug 31.
- Background Tobouti PL, de Andrade Martins TC, Pereira TJ, Mussi MCM. Antimicrobial activity of copaiba oil: A review and a call for further research. Biomed Pharmacother. 2017 Oct;94:93-99. doi: 10.1016/j.biopha.2017.07.092. Epub 2017 Jul 27.
- Background da Trindade R, da Silva JK, Setzer WN. Copaifera of the Neotropics: A Review of the Phytochemistry and Pharmacology. Int J Mol Sci. 2018 May 18;19(5):1511. doi: 10.3390/ijms19051511.
- Background Valadas LAR, Gurgel MF, Mororo JM, Fonseca SGDC, Fonteles CSR, de Carvalho CBM, Fechine FV, Rodrigues Neto EM, de Franca Fonteles MM, Chagas FO, Lobo PLD, Bandeira MAM. Dose-response evaluation of a copaiba-containing varnish against streptococcus mutans in vivo. Saudi Pharm J. 2019 Mar;27(3):363-367. doi: 10.1016/j.jsps.2018.12.004. Epub 2018 Dec 15.
- Background Wagner VP, Webber LP, Ortiz L, Rados PV, Meurer L, Lameira OA, Lima RR, Martins MD. Effects of Copaiba Oil Topical Administration on Oral Wound Healing. Phytother Res. 2017 Aug;31(8):1283-1288. doi: 10.1002/ptr.5845. Epub 2017 Jun 21.
- Background Yarom N, Ariyawardana A, Hovan A, Barasch A, Jarvis V, Jensen SB, Zadik Y, Elad S, Bowen J, Lalla RV; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of natural agents for the management of oral mucositis in cancer patients. Support Care Cancer. 2013 Nov;21(11):3209-21. doi: 10.1007/s00520-013-1869-5. Epub 2013 Jun 14.
- Background Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8.
- Background INCA, I. N. de C. Cuidados paliativos oncológicos. Cuidados Paliativos Oncológicos. [s.l.]: [s.n.], 2001. v. 22, 2055-2066 p. ISBN: 857318079X
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copaiba | Unknown | 10 % | Other |
| Subject | Copaiba | Unknown | 15 % | Other |