Quality of Life Before and After Radiotherapy in Patients With Head and Neck Cancer

May 6, 2025 updated by: Jacopo Lanzetti, University of Turin, Italy

A Pilot Investigation of the Quality of Life Before and After Radiotherapy in Patients With Head and Neck Cancer

Worldwide, head and neck cancers (HNCs) are widespread (650,000 cases per year) and cause more than 330,000 deaths per year. Almost all cases, about 90%, are cancers of the oral cavity, oropharynx, and larynx.

In conventional clinical practice, HNCs are treated primarily with radiation therapy (RT), often used in combination with surgery and/or chemotherapy. Like most anti-neoplastic therapies, RT carries significant adverse effects both acute and chronic. Both types of adverse effects have a significant impact on quality of life (QoL).

The aim of the study is to examine the worsening of QoL in patients with HNC before and after cancer therapy and to assess the extent that each factor has in its worsening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

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

  • Italy
      • Torino, Italy, 10126
        • AOU Città della Salute e della Scienza

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Head and Neck Cancer and waiting to undergo curative radiotherapy. HNC patients attach great importance to their health-related quality of life. In addition, there is evidence that the QoL of HNC survivors is poorer than that of the general population due to the significant functional limitations caused by the disease and treatment, this is because the head and neck district is the site of several organs that play an important role in the basic functions of daily life, including breathing, speeching, chewing, and swallowing, and are important for appearance. Moreover, HNC leads to a high incidence of psychosocial problems among survivors, such as depression, social isolation, and addiction and substance abuse, which in turn post to negative consequences with regard to QoL.

Description

Inclusion Criteria:

  • patients between the ages of 18 and 75 years;
  • patients who presented at their first dental visit with a diagnosis of HNC.

Exclusion Criteria:

  • patients who had already undergone cancer therapies (excisional surgery or chemotherapy or radiation therapy) at the time of the first dental visit;
  • patients with depression or social anxiety;
  • patients with language difficulties.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HNC and waiting to undergo curative radiotherapy
Radiation: Curative radiotherapy for Head and Neck Cancers
Radiotherapy is a localized, non-invasive, painless therapy, mostly performed on an outpatient basis, capable of causing necrosis or the death of tumor cells through the use of high-energy radiation called ionizing radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of Washington Quality of Life Questionnaire version 4.1
Time Frame: 1 month
The UW-QOL v4.1 is a widely recognized questionnaire for reporting physical and socio-emotional dysfunction after HNC treatment and consists of short multifactorial questions specific to HNC and to assess the patient's perception of general QoL in the past 7 days. The questionnaire includes 12 questions to assess pain, appearance, activity, leisure, swallowing, chewing, speech, shoulder, taste, salivation, mood, and anxiety. There are two subdomains: physical and social-emotional. The physical function items are chewing, speech, swallowing, taste, saliva and appearance. Social function includes anxiety, mood, pain, activity, recreation, and shoulder function.
1 month

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

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 (Actual)

January 2, 2025

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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