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

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: Head and Neck Cancer; Quality of Life (QOL)
• Intervention / Treatment: Radiation: Curative radiotherapy for Head and Neck Cancers

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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

• Sponsor: University of Turin, Italy

Study record dates

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: Head and Neck Cancer; Quality of Life; Radiotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• 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