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2014 ; 50
(8
): 765-9
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Phase II multicenter trial of Caphosol for the reduction of mucositis in patients
receiving radiation therapy for head and neck cancer
#MMPMID24954065
Rao NG
; Trotti A
; Kim J
; Schell MJ
; Zhao X
; Amdur RJ
; Brizel DM
; Chambers MS
; Caudell JJ
; Miyamoto C
; Rosenthal DI
Oral Oncol
2014[Aug]; 50
(8
): 765-9
PMID24954065
show ga
PURPOSE: We conducted a phase II multicenter study evaluating Caphosol in
patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic
sensitizer. MATERIALS/METHODS: The primary endpoint of the study tested the rate
of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75%
of patients would develop > or equal to 2 mucositis with Caphosol compared with a
historical rate of >90%. New methods were applied with higher than historic
rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC),
MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC),
University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol
was taken by patients at least 4 times a day and up to 10 times per day
commencing with day 1 of RT and for a total duration of 8 weeks after completion
of RT. Detailed questionnaires were completed weekly by patients and a unique
algorithm was used to generate the WHO grade of mucositis. RESULTS: 98 Patients
were enrolled in the study. 59/98 (60%) patients were evaluable for the primary
endpoint giving us 80% power. All evaluable patients experienced WHO grade > or
equal to 2 mucositis and the trial failed to reject the null hypothesis. > or
equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%,
98%, 71%, 50%. CONCLUSION: We were unable to demonstrate that Caphosol
significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate.
We are not surprised with this finding given our rigorous methodology in grading.