Oral Mucositis — Study for the Prevention of Oral Mucositis (SPOM)
Citation(s)
Abstracts for MASCC/ISOO Annual Meeting 2019 Support Care Cancer. 2019 May 18:1-302. doi: 10.1007/s00520-019-04813-1. Online ahead of print. No abstract available. Erratum In: Support Care Cancer. 2019 Aug 29;:303-318.
Elad S, Yarom N The Search for an Effective Therapy and Pain Relief for Oral Mucositis. JAMA. 2019 Apr 16;321(15):1459-1461. doi: 10.1001/jama.2019.3269. No abstract available.
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.
Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S Oral mucositis and outcomes of allogeneic hematopoietic stem-cell transplantation in patients with hematologic malignancies. Support Care Cancer. 2007 May;15(5):491-6. doi: 10.1007/s00520-006-0176-9. Epub 2006 Dec 1.
A Phase 1/Phase 2 Study for the Prevention of Oral Mucositis (SPOM)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
