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Abnormalities, Radiation-InducedPhase 2EUWSFDARNCT00741754

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

A Phase 2 study testing Mouthrinse with HcT20 in people with Abnormalities, Radiation-Induced, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 82 years
Conditions the study is for
Abnormalities, Radiation-Induced
What is being tested?
Mouthrinse with HcT20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteBrazil
Study dates
Jun 2005to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Dental School - São Paulo State University

    Araçatuba, São Paulo, 16015-050

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Mouthrinse with HcT20
Keywords
salivary flow, oral neoplasm, calcium hydroxide, sodium dodecylsulphate, radiotherapy.
Medical subject headings
Abnormalities, Radiation-Induced, Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mouthrinse with HcT20Other

    Also called HcT20

    Mouthrinse for 1 minute with 10ml, twice a day. During seven weeks

Study groups in NCT00741754
Study groupRoleWhat they receive
I, IIExperimentalcompare the amount of salivary flow of the same patient at different times.
Receives: Other: Mouthrinse with HcT20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. unstimulated whole saliva flow

    Measured: ml

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2008 (estimated)
  2. Study startJun 2005
  3. Primary completionMay 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741754
Sponsor's protocol ID
upeclin/FOA-Unesp-01
Other IDs
COB-FOA-Unesp-chrishct20
Acronym
EUWSFDAR
Status last verified
Aug 2008
First submitted
25 Aug 2008
Last updated
1 Apr 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Larson DL. Long-term effects of radiation therapy in the head and neck. Clin Plast Surg. 1993 Jul;20(3):485-90.

    PubMed 8324987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mouthrinse with HcT20 in people with Abnormalities, Radiation-Induced, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

unstimulated whole saliva flow (time frame: ml). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.

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