Cancer — Prevention of Capecitabine Induced Hand and Foot Syndrome
Citation(s)
Abushullaih S, Saad ED, Munsell M, Hoff PM Incidence and severity of hand-foot syndrome in colorectal cancer patients treated with capecitabine: a single-institution experience. Cancer Invest. 2002;20(1):3-10.
Borkow G, Gabbay J Putting copper into action: copper-impregnated products with potent biocidal activities. FASEB J. 2004 Nov;18(14):1728-30. Epub 2004 Sep 2.
Karlström AR, Levine RL Copper inhibits the protease from human immunodeficiency virus 1 by both cysteine-dependent and cysteine-independent mechanisms. Proc Natl Acad Sci U S A. 1991 Jul 1;88(13):5552-6.
Kim JH, Cho H, Ryu SE, Choi MU Effects of metal ions on the activity of protein tyrosine phosphatase VHR: highly potent and reversible oxidative inactivation by Cu2+ ion. Arch Biochem Biophys. 2000 Oct 1;382(1):72-80.
Ueda K, Morita J, Yamashita K, Komano T Inactivation of bacteriophage phi X174 by mitomycin C in the presence of sodium hydrosulfite and cupric ions. Chem Biol Interact. 1980 Feb;29(2):145-58.
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.