Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract (TOQUAL)

March 12, 2015 updated by: Centre Francois Baclesse
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • France
      • Caen, France, 14076
        • Centre Francois Baclesse

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient (e) old (e) over 18 years
  • Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
  • Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
  • Indication of head and neck radiotherapy bilateral
  • All of the TNM stage except metastatic
  • Patient has signed informed consent for participation in the study
  • Mastery of the French language

Exclusion Criteria:

  • History of head and neck radiotherapy
  • Indication of head and neck radiotherapy unilateral
  • Personal history of malignant tumors uncontrolled over the past 5 years
  • History of oral sicca syndrome
  • Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
  • Concomitant treatment with amifostine
  • Concomitant treatment with cetuximab
  • Primary tumor of the salivary glands
  • Head and neck hyperfractionated radiotherapy and / or accelerated
  • Head and neck radiotherapy hypofractionated
  • Metastatic disease
  • Patient deprived of liberty, under guardianship
  • Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
  • Refusal of the patient.

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients with xerostomia
Time Frame: 12 months after completion of radiotherapy.
Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.
12 months after completion of radiotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of acute and late xerostomia
Time Frame: after 3, 6 and 12 months after radiotherapy
Evaluation of acute xerostomia
after 3, 6 and 12 months after radiotherapy
Measurement of salivary flow with and without stimulation
Time Frame: at 3, 6 and 12 months after end of radiotherapy
Measurement of salivary flow with and without stimulation
at 3, 6 and 12 months after end of radiotherapy
Evaluation of the incidence of acute side effects of radiotherapy
Time Frame: Weekly during radiotherapy
Evaluation of the incidence of acute and late side effects of radiotherapy
Weekly during radiotherapy
Evaluation of the incidence of late side effects of radiotherapy
Time Frame: At 3, 6 and 12 months after radiotherapy
Evaluation of the incidence of late side effects of radiotherapy
At 3, 6 and 12 months after radiotherapy
Evaluation of quality of life and fatigue
Time Frame: At 3, 6 and 12 months after radiotherapy
Evaluation of quality of life and fatigue
At 3, 6 and 12 months after radiotherapy
Evaluation of overall survival and progression-free survival
Time Frame: at 3, 6 and 12 months after radiotherapy
Evaluation of overall survival and progression-free survival
at 3, 6 and 12 months after radiotherapy

Collaborators and Investigators

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

Sponsor

Centre Francois Baclesse

Investigators

  • Principal Investigator: bernard GERY, MD, Centre Francois Baclesse

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

May 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOQUAL

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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