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

NCT06807697 | Completed DMC

• 1 other identifier: 00424
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Quality of Life (QOL)

Keywords

Quality of Life; Head and Neck Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with HNC and waiting to undergo curative radiotherapy

Radiation: Curative radiotherapy for Head and Neck Cancers

Interventions

Curative radiotherapy for Head and Neck Cancers RADIATION

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.

Patients with HNC and waiting to undergo curative radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Dental Hygiene

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 2, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

IT (1)