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Completed

NCT Number: NCT06807697

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Città della Salute e della Scienza

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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