title: The impact of phase I clinical trials on the quality of life of patients with cancer.
abstract: This prospective, non-randomized study was designed to evaluate the quality of life (QOL) of cancer patients receiving new cytotoxic therapy. QOL was measured using a linear analog self assessment scale (LASA). Cancer patients who received a phase I agent (n = 45) had no significant changes in any of the individual QOL variables, overall QOL (p = 0.77) or performance status (p = 0.08) following one course of phase I therapy. However, patients who were not eligible for entry on a phase I protocol and who received supportive care (n = 10) experienced significant decreases in overall QOL (p = 0.02) and performance status (p = 0.003) after 1 month of follow-up. This pilot study suggests that participation in phase I trials does not adversely affect one's QOL.
authors.affiliation: Department of Medicine, University of Maryland Cancer Center, Baltimore 21201.
authors.forename: T J
authors.initials: TJ
authors.lastname: Melink
authors.forename: G M
authors.initials: GM
authors.lastname: Clark
authors.forename: D D
authors.initials: DD
authors.lastname: Von Hoff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000523:psychology*; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents