Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis
in patients receiving radiation therapy for head and neck cancer.
Author(s): Lalla RV(1), Choquette LE(2), Curley KF(2), Dowsett RJ(2), Feinn RS(3), Hegde
UP(2), Pilbeam CC(2), Salner AL(4), Sonis ST(5), Peterson DE(2).
Affiliation(s): Author information:
(1)University of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT
06030, USA. Electronic address: Lalla@uchc.edu.
(2)University of Connecticut Health Center, 263 Farmington Avenue, Farmington, CT
06030, USA.
(3)Frank Netter MD School of Medicine at Quinnipiac University, 275 Mount Carmel
Avenue, Hamden, CT 06518, USA.
(4)Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, USA.
(5)Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.
Publication date & source: 2014, Oral Oncol. ,
OBJECTIVES: Oral mucositis (OM) is a painful complication of radiation therapy
(RT) for head and neck cancer (H&NC). OM can compromise nutrition, require opioid
analgesics and hospitalization for pain control, and lead to treatment
interruptions. Based on the role of inflammatory pathways in OM pathogenesis, we
investigated effect of cyclooxygenase-2 (COX-2) inhibition on severity and
morbidity of OM.
METHODS: In this double-blind placebo-controlled trial, 40 H&NC patients were
randomized to daily use of 200mg celecoxib or placebo, for the duration of RT.
Clinical OM, normalcy of diet, pain scores, and analgesic use were assessed 2-3
times/week by blinded investigators during the 6-7week RT period, using validated
scales.
RESULTS: Twenty subjects were randomized to each arm, which were similar with
respect to tumor location, radiation dose, and concomitant chemotherapy. In both
arms, mucositis and pain scores increased over course of RT. Intention-to-treat
analyses demonstrated no significant difference in mean Oral Mucositis Assessment
Scale (OMAS) scores at 5000cGy (primary endpoint). There was also no difference
between the two arms in mean OMAS scores over the period of RT, mean worst pain
scores, mean normalcy of diet scores, or mean daily opioid medication use in IV
morphine equivalents. There were no adverse events attributed to celecoxib use.
CONCLUSIONS: Daily use of a selective COX-2 inhibitor, during period of RT for
H&NC, did not reduce the severity of clinical OM, pain, dietary compromise or use
of opioid analgesics. These findings also have implications for celecoxib use in
H&NC treatment regimens (NCT00698204).
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