Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Radiotherapy plays an important role in the curative treatment of head and neck cancer. This treatment however is associated with significant acute and late toxicity with xerostomia and dysphagia severely implicating the patient's quality of life. With highly conformal radiotherapy techniques it is possible to decrease de dose to the organs at risk while maintaining adequate doses to the tumour. In order to adequately register the effect of these techniques it is imperative to obtain standardized information on the acute and late treatment effects. With this study the investigators want to evaluate this toxicity using standardized and validated questionnaires during follow-up. This data will then be correlated to the doses delivered to the specific organs at risk.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01548846

Head and Neck Cancer Radiotherapy by Tomotherapy Exclusive With or Without Concurrent Chemotherapy

TERMINATED PHASE2

Frequency of Xerostomia and Their Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy

NCT02857413

Head and Neck Neoplasms

COMPLETED

Normalcy of Food Intake in Head and Neck Cancer Patients

NCT01110980

Neoplasms, Head and Neck

COMPLETED NA

Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia

NCT00081029

Head and Neck Cancer Radiation Toxicity Xerostomia

UNKNOWN PHASE3

A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer

NCT02941276

Xerostomia Head and Neck Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction Radiotherapy is one of the main curative treatment options in advanced head and neck cancer. With the introduction of altered fractionation schedules and concurrent chemotherapy locoregional control numbers and overall survival have improved significantly. This has come at the cost of excess in acute and late toxicity. The steep dose gradients associated with more conformal radiotherapy techniques such as intensity modulated radiotherapy (IMRT) allows us to maintain adequate coverage of the target volume while reducing the dose to the surrounding normal tissues, thus potentially sparing these from excess acute and late toxicity. However to accurately evaluate the value of these new techniques documentation of treatment related toxicity and quality of life is essential. Standardized quality of life scoring systems have been developed for this purpose. Especially xerostomia is very hard to evaluate, although it remains an important issue in the follow-up of these patients.

Purpose In this study the investigators want to analyze treatment related toxicity, with special emphasis on xerostomia and dysphagia in patients treated with radiotherapy for head and neck cancer by presenting them with standardized quality of life questionnaires at well defined points after treatment (2 months, six months, one year ,two years after RT). The result of these questionnaires will then be correlated to treatment data.

Study Design The investigators will include all patient which are in follow-up after primary (chemo-)radiotherapy for head and neck cancer for a period 4 years. At well defined time points after primary (chemo-)radiotherapy for head and neck cancer the investigators will ask the patient to fill in standardized questionnaires compromising of the EORTC QLQ H\&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory. The treating physician will score the toxicity using the RTOG/EORTC late toxicity scoring system and the functional oral intake scale (FOIS).

This toxicity data will then be analyzed and correlated with treatment data. Special interest will go to the relationship between the presence of xerostomia and the doses delivered to subvolumes of the parotid glands, the submandibular glands and oral cavity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Neoplasms Xerostomia Deglutition Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
* Stage T1-4,N0-3; for cancer of the glottis T3-4 or TxN1-3
* Decision for curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors.
* \>18 years of age

Exclusion Criteria

* Previous surgery of the primary tumor or lymph nodes
* Tumour recurrence, locoregional or distant
* Mental condition rendering the patient unable to understand or fill in the questionnaires

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No