Radiation Toxicity — Normal Tissue Oxygenation Following Radiotherapy
Citation(s)
Archambeau JO, Pezner R, Wasserman T Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
Delanian S, Depondt J, Lefaix JL Major healing of refractory mandible osteoradionecrosis after treatment combining pentoxifylline and tocopherol: a phase II trial. Head Neck. 2005 Feb;27(2):114-23. doi: 10.1002/hed.20121.
Delanian S, Porcher R, Rudant J, Lefaix JL Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.
Denham JW, Hauer-Jensen M The radiotherapeutic injury--a complex 'wound'. Radiother Oncol. 2002 May;63(2):129-45. doi: 10.1016/s0167-8140(02)00060-9.
Hauser CJ, Shoemaker WC Use of a transcutaneous PO2 regional perfusion index to quantify tissue perfusion in peripheral vascular disease. Ann Surg. 1983 Mar;197(3):337-43. doi: 10.1097/00000658-198303000-00014.
Marx RE, Johnson RP, Kline SN Prevention of osteoradionecrosis: a randomized prospective clinical trial of hyperbaric oxygen versus penicillin. J Am Dent Assoc. 1985 Jul;111(1):49-54. doi: 10.14219/jada.archive.1985.0074.
Moore DS and McCabe GP Introduction to the practice of statistics. New York: W.H. Freeman and Co., 2006.
Rudolph R, Tripuraneni P, Koziol JA, McKean-Matthews M, Frutos A Normal transcutaneous oxygen pressure in skin after radiation therapy for cancer. Cancer. 1994 Dec 1;74(11):3063-70. doi: 10.1002/1097-0142(19941201)74:113.0.co;2-c. Erratum In: Cancer 1995 Mar 1;75(5):1218.
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.
