Trial Information

Evaluation of the Unstimulated Whole Saliva Flow During and After Radiotherapy, With the Use of Lauryl-Diethylene-Glycol-Ether Sodium Sulfate Associated With Calcium Hydroxide (hCt20).

Thirty one patient were observed and treated at Oral Cancer Center - Brazil, between March
1997 and June 2006, distributed into two groups the following way: Group I composed of
seventeen patients who utilized Hct20 during the period of the radiotherapy and Group II
composed of fourteen patients who utilized the drug association from the radiotherapeutic
treatment. The average of the patients in group I was of 58.8 and Group II 64.7 years old.
In the distribution, as to sex, group I was composed by fourteen males and three females and
in group II 11 male and four female.As to their color, group I presented sixteen white
patients and one non-white and group II presented 12 white and two non-white. From the
patients in group I, eight referred elitism, six reported social elitism and three denied
it; from the patients in group II five referred elitism, two reported social elitism and
seven denied it. All the patients, in both groups, presented lesions with primary site in
the mouth, oropharynx or larynx with diagnosis of squamous cell carcinoma. The patients
included in this research were carriers of oral and oropharynx squamous cell carcinoma
guided for exclusive radiotherapeutic treatment.To be accepted in this study, it was
established as a requirement that the fields of irradiation included in all occasions the
major salivary glands, partially or totally.Patients who used medical drugs wich could
interfere in the salivary flow rate, with teeth, mucositis or any other alteration of the
oral mucosa after radiotherapy was excluded.Group I was composed of seventeen patients
(n=17)that performed eight saliva collection, being one before the treatment (c0) and seven
collection (C1to C7) during seven weeks of radiotherapy utilizing Hct20.Group II was
composed of fourteen patients (n=14) Who performed nine collections, being one collection
(C7) at the end of the treatment without utilizing Hct20, six collections (c8 to C13)
utilizing Hct20 the first two months after radiotherapy and two collections (C14 and C15)
with three and four months after radiotherapy and after suspending the use of Hct20.The
total dose administered to the patients was of 7000 cGy, fractioned in doses of 200 cGy
daily, with Five fractions weekly. The composition of Hct20 is 800 ml distilled water, 200
ml of lauryl-diethylene-glycol-ether sodium sulfate (0.125 g/ml) and 2 g of calcium
hydroxide.The patients received a vial containing Hct20 and were oriented to perform two
oral rinses daily with 10 ml.The collections of unstimulated whole saliva were weekly
performed always in the same day of the week, around the same time, before breakfast,
without oral hygienization, in the same office with the same illumination and silence and
without the presence of companies in the period of the patient in the office.The patients
expelled the unstimulated salivary secretion in a test tube calibrated in cubic millimeters
with a funnel of eight centimeters of diameter adapted to it.At the end of the collections,
wich lasted five minutes, were added three ml of distilled water to each sample, which was
stored in a temperature of 6 degree Celsius for 24 hours in order to decrease the bubbles
and the foams of the samples. The three ml added to the end of the collection were despised
at the moment of the final reading.The values that were obtained were analyzed statistically
through the Bartlett test, the Friedman test and the Wilcox test, to seek an evaluation of
effectiveness of the medication on the prevention of the intense drop of the salivary flow
during the radiotherapy and do avoid the xerostomia during the post-radiotherapeutic period.
The patients from group 1 at the end of the radiotherapy kept the base index of the total
non stimulated salivary flow, the ones from group 2 that used the medication association
after the radiotherapy had a great improvement of total non stimulated salivary flow and the
usage of the Hct20 had a better result on the index of salivary flow during the
radiotherapy.