Evaluation of the Unstimulated Whole Saliva Flow During and After Radiotherapy, With the Use HcT20 (EUWSFDAR)

March 30, 2009 updated by: UPECLIN HC FM Botucatu Unesp

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Araçatuba, São Paulo, Brazil, 16015-050
        • Dental School - São Paulo State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presented lesions with primary site in the mouth, oropharynx or larynx with diagnosis of squamous cell carcinoma.
  • the patients were edentulous
  • The patients included were 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I, II
compare the amount of salivary flow of the same patient at different times.
Other: Mouthrinse with HcT20
Mouthrinse for 1 minute with 10ml, twice a day. During seven weeks
Other Names:
  • HcT20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
unstimulated whole saliva flow
Time Frame: ml
ml

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Éder Ricardo Biasoli, DdS, MsC, PhD. Professor of Oral Diagnosis, School of Dentistry, São Paulo State University - UNESP - Araçatuba - SP - Brazil.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/FOA-Unesp-01
  • COB-FOA-Unesp-chrishct20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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