Evaluation of the Unstimulated Whole Saliva Flow During and After Radiotherapy, With the Use HcT20
Condition: Abnormalities, Radiation-Induced
MeSH terms: Abnormalities, Radiation-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this report was to evaluate the unstimulated whole saliva flow in patients with
      head and neck cancers during and after the exclusive radiotherapy with an association of
      lauryl-diethylene-glycol-ether sodium sulfate and calcium hydroxide (Hct20). This study was
      held at the buccal cancer center of UNESP and involved thirty one patients (n = 31) divided
      into two groups: Group 1 had seventeen patients (n = 17) submitted to fractioned radiation
      treatment in the head and neck region at the total dose of 7.000 cGy and had Hct20 during the
      treatment. Group 2 with fourteen patients (n = 14) started with the use of Hct20 after the
      end of radiotherapy. A weekly and measured collection of the index of the total non
      stimulated saliva flow was done on the patients of both groups. 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.
    

Detailed description: 
      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.
    

Intervention name(s): Mouthrinse with HcT20
Intervention type(s): Other
Intervention description(s): Mouthrinse for 1 minute with 10ml, twice a day. During seven weeks
Other intervention name(s): HcT20
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: salivary flow; oral neoplasm; calcium hydroxide; sodium dodecylsulphate; radiotherapy.