NCT02604329 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bensadoun RJ, Nair RG
Low-level laser therapy in the prevention and treatment of cancer therapy-induced mucositis: 2012 state of the art based on literature review and meta-analysis. Curr Opin Oncol. 2012 Jul;24(4):363-70. doi: 10.1097/CCO.0b013e328352eaa3. Review.
Glenny AM, Gibson F, Auld E, Coulson S, Clarkson JE, Craig JV, Eden OB, Khalid T, Worthington HV, Pizer B; Children's Cancer and Leukaemia Group (CCLG)/Paediatric Oncology Nurses Forum's (CCLG-PONF) Mouth Care Group
The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer. Eur J Cancer. 2010 May;46(8):1399-412. doi: 10.1016/j.ejca.2010.01.023. Epub 2010 Mar 11. Review.
Huang YY, Sharma SK, Carroll J, Hamblin MR
Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.
Qutob AF, Gue S, Revesz T, Logan RM, Keefe D
Prevention of oral mucositis in children receiving cancer therapy: a systematic review and evidence-based analysis. Oral Oncol. 2013 Feb;49(2):102-7. doi: 10.1016/j.oraloncology.2012.08.008. Epub 2012 Sep 7. Review.
Sonis ST
Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.1200/EdBook_AM.2013.33.e236. Review.

Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy

Clinical trial NCT02604329 - References