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

NCT00741754 | Completed Phase 2 DMC

• 2 other identifiers: upeclin/FOA-Unesp-01COB-FOA-Unesp-chrishct20
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abnormalities, Radiation-Induced

Keywords

salivary flow; oral neoplasm; calcium hydroxide; sodium dodecylsulphate; radiotherapy.

Outcome Measures

Primary Outcomes (1)

• unstimulated whole saliva flow

  ml

Study Arms (1)

I, II

EXPERIMENTAL

compare the amount of salivary flow of the same patient at different times.

Other: Mouthrinse with HcT20

Interventions

Mouthrinse with HcT20 OTHER

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

Also known as: HcT20

I, II

Eligibility Criteria

• Age: 40 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Dental School - São Paulo State University

Araçatuba, São Paulo, 16015-050, Brazil

Location

Related Publications (1)

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

  PMID: 8324987 RESULT

MeSH Terms

Conditions

Abnormalities, Radiation-Induced; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Radiation Injuries; Wounds and Injuries; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Éder Ricardo Biasoli

  DdS, MsC, PhD. Professor of Oral Diagnosis, School of Dentistry, São Paulo State University - UNESP - Araçatuba - SP - Brazil.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: June 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 1, 2009

Record last verified: 2008-08

Locations

BR (1)