title: A randomized double-blind placebo-controlled cross-over trial of the impact on quality of life of continuing dexamethasone beyond 24 h following adjuvant chemotherapy for breast cancer.
abstract: Uncertainty remains about the optimal anti-emetic regimen for control of delayed nausea and vomiting after adjuvant chemotherapy for breast cancer. Many patients receive dexamethasone but complain of insomnia, anxiety/agitation, and indigestion. The aim was to determine if patients receiving chemotherapy for breast cancer prefer treatment with dexamethasone or placebo for prophylaxis against delayed nausea and vomiting, and to compare quality of life (QOL) between the two treatments. In this randomized, double-blind, cross-over trial, we compared oral dexamethasone (4 mg twice daily for 2 days) versus placebo for chemotherapy-naïve patients with breast cancer. All patients received intravenous granisetron and dexamethasone pre-chemotherapy and oral granisetron on day 2. Primary endpoints were: (i) patient preference; (ii) difference between cycles in change of QOL from days 1 to 8. Median age of the 94 women was 51 years (range 27-76): 79 received fluorouracil/epirubicin/cyclophosphamide and 15 received doxorubicin/cyclophosphamide. Thirteen withdrew pre-cycle 2 with no differences between arms. Of 80 patients stating a preference, 31 preferred placebo (39 %, 95 % CI: 28-50 %) and 37 (46 %, 95 % CI: 35-58 %) preferred dexamethasone; 12 had no preference. There were no differences in intensity of vomiting, nausea, or time to onset of vomiting. There was greater decrease in global QOL (p = 0.06) when patients received dexamethasone. No other symptom/QOL domains differed significantly. In conclusion, no significant difference was found in patient preference, QOL, or symptoms regardless of whether dexamethasone or placebo was used after adjuvant chemotherapy.
authors.affiliation: Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada. janette.vardy@sydney.edu.au
authors.forename: J
authors.initials: J
authors.lastname: Vardy
authors.forename: G
authors.initials: G
authors.lastname: Pond
authors.forename: A
authors.initials: A
authors.lastname: Dodd
authors.forename: D
authors.initials: D
authors.lastname: Warr
authors.forename: B
authors.initials: B
authors.lastname: Seruga
authors.forename: M
authors.initials: M
authors.lastname: Clemons
authors.forename: L
authors.initials: L
authors.lastname: Bordeleau
authors.forename: P
authors.initials: P
authors.lastname: Goodwin
authors.forename: I F
authors.initials: IF
authors.lastname: Tannock
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000473:pathology; D005260:Female; D017829:Granisetron / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life
chemical_list: D003907:Dexamethasone; D017829:Granisetron