Head and Neck CancerNCT06807697
Quality of Life Before and After Radiotherapy in Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer and Quality of Life (QOL), run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Quality of Life (QOL)
- What is being tested?
- Curative radiotherapy for Head and Neck Cancers
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2025to 30 Apr 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients between the ages of 18 and 75 years;
- patients who presented at their first dental visit with a diagnosis of HNC.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Cancer, Quality of Life (QOL)
- Being tested
- Curative radiotherapy for Head and Neck Cancers
- Keywords
- Quality of Life, Head and Neck Cancer, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative radiotherapy for Head and Neck CancersRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HNC and waiting to undergo curative radiotherapy | Not described Receives: Radiation: Curative radiotherapy for Head and Neck Cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start2 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Lanzetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807697
- Sponsor's protocol ID
- 00424
- Status last verified
- May 2025
- First submitted
- 29 Jan 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lanzetti J, Ferrati F, Bartolomeo M, Crupi A, Gibello U, Mussano F, Pera F. A pilot study of quality of life domains before and after radiotherapy in patients with head and neck cancer. Cancer Treat Res Commun. 2026;47:101232. doi: 10.1016/j.ctarc.2026.101232. Epub 2026 Apr 28.
PubMed 42066680
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of the Quality of Life Before and After Radiotherapy in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06807697
- Acronym / sponsor ID
- 00424
- Conditions
- Head and Neck Cancer, Quality of Life (QOL)
- Keywords
- Quality of Life, Head and Neck Cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HNC and waiting to undergo curative radiotherapy | – | Radiation: Curative radiotherapy for Head and Neck Cancers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients between the ages of 18 and 75 years;
- patients who presented at their first dental visit with a diagnosis of HNC.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative radiotherapy for Head and Neck CancersRadiotherapy 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. | Radiation | Patients with HNC and waiting to undergo curative radiotherapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42066680Lanzetti J, Ferrati F, Bartolomeo M, Crupi A, Gibello U, Mussano F, Pera F. A pilot study of quality of life domains before and after radiotherapy in patients with head and neck cancer. Cancer Treat Res Commun. 2026;47:101232. doi: 10.1016/j.ctarc.2026.101232. Epub 2026 Apr 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Quality of Life (QOL), run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Washington Quality of Life Questionnaire version 4.1 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.