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New study evaluating the effect of CAPHOSOL in reducing Oral Mucositis in head and neck cancer patients undergoing chemo-radiotherapy or radiotherapy
M.Thomson. BEATSON ONCOLOGY CENTRE WESTERN INFIRMARY, Glasgow, UK
The purpose of this study was to evaluate the
implementation of Caphosol in the prevention and treatment of
mucositis in patients undergoing Radiotherapy or Chemo-radiotherapy
whose treatment fields included a large part of the oral cavity.
compared to the previous standard treatment.
Materials: 60 patients undergoing whole mouth irradiation for
oral and oropharynx cancers over a 6 month period in 2010 were
included in the assessment. Patients suitable for inclusion in the
study were selected by a consultant radiographer. A retrospective
review of 30 patients who had completed radiotherapy receiving the
standard treatment were compared to 30 patients who had received
Patients were treated according to the following regimen: 36
patients: 68Gy in 34 fractions; 24 patients: 66Gy in 33 fractions.
All patients were instructed to rinse with Caphosol 4 times daily
from the start of radiotherapy until radiation therapy was
Caphosol was prescribed on a weekly basis so that compliance to
study medication could be assessed. Patients were monitored through
weekly clinic assessment for: Grade of oral mucositis - using the
CTC/EORTC/RTOG assessment scale (range 0-4); Weight change;
Performance status - assessed using the WHO Scale (range 0-4); Oral
intake - assessed using the BWoSCC scale (range 0-4); Pain - using
the WHO Pain Ladder which includesa patient self-assessment.
Results: The results from the statistical analysis showed
statistical significance in Oral Mucositis (OM)grade and in
analgesic steps. OM grade showed statistical significance for weeks
3,4,5,6 and 7 with a p values of 0.004 for week3, p=0 for week4,
p=0 for week 5 and p=0 for week 6. Week 7 had a different sample
size N=17 for Caphosol and N=12 for Corsodyl. Week 7 had a p value
of 0. The median for Caphosol was lower in each of theseweeks which
showed Caphosol improved OM grade.Results for the analgesic steps
were similar. Week 1,2,and 3 showed no statistical significance and
week 4, 5, 6 and 7 all showed a significant diference between the
two mouthwashes. P value for week4 was 0, week 5 p=0.001 and week 6
p=0.001. Again week 7 had a different sample size but showed a
statistical difference with a p value of 0.003.The results for oral
intake showed no statistically significant difference between the
mouthwashes for weeks 1 and 2. Week,3 4, 5, and 6 all showed
statistically significant differnece with p values of 0.004 for
week3, p=0.32 for week4, p=0.01 for week 5 and p=0.02 for week 6.
This shows that patients using Caphosol can eat more orally during
Conclusions:Positive: Results encouraging with statistical
significance in the reduction of overall grade of OM and the
reduction in the use of analgesia. Caphosol worthy of further
investigation in the weeks immediately prior to completion of
radiotherapy treatment in the area of head and neck cancers.
Results consistent with previously published studies in head and
neck cancer and other therapy areas.
Limitations : Mucositis graded by members of MDT so possibility
of inconsistency in grading limited to 4 rinses per day only no
advice to increase in line with symptoms as per product information
which states can increase to 10 per day.