Predicting and understanding pain six months after radiotherapy for head and neck cancer
Official title: Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
Run by University Hospital, Caen · NCT05505188 · Data updated 2026-11-12
This project will see if people treated with radiotherapy for head and neck cancer who still have pain at six months are more likely to keep smoking or drinking, be depressed, feel very tired, or have worse overall quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Status | Recruiting |
| Started | March 13, 2023 |
| Main results expected | March 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT05505188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult (over 18), French-speaking patients with a first head and neck cancer treated with radiotherapy, WHO performance status below 3, life expectancy greater than three months, no prior radiotherapy, and no evidence of recurrence are ideal candidates.
✕Probably not a fit
Patients with prior radiotherapy, recurrent or progressive cancer, recent mutilating surgery causing swallowing sequelae, uncontrolled infection, non–French speakers, or very poor performance status are unlikely to match the study population and may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-center prospective cohort of about 120 French-speaking patients with a first head and neck cancer treated with radiotherapy who will be followed to six months after treatment. Participants will complete standardized questionnaires about pain, analgesic use, substance use (tobacco and alcohol), mood symptoms, fatigue, and global quality of life. Investigators will measure the prevalence of chronic pain at six months and analyze correlations between persistent pain and continued addictions, depressive symptoms, asthenia, and quality-of-life scores. The goal is to identify clinical patterns that predict which patients are at higher risk of long-term pain and related psychosocial problems.
Why it matters
Potential benefit: If links are confirmed, the results could help clinicians identify patients at higher risk for long-term pain and target early support for pain management, addiction counseling, and mental health care to improve quality of life.
How similar studies have gone: Previous observational studies have documented persistent pain and its negative impact on quality of life and substance use after head and neck cancer, so this study builds on existing evidence rather than testing a wholly novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a first Head and neck cancer whose therapeutic sequence involves radiotherapy * Patient over 18 years of age * Having given written consent * patient not previously treated with radiotherapy * Life expectancy \> 3 months * World Health Organization (WHO) score \< 3 * Histologically proven Head and Neck cancer * Stable patient, with no signs of recurrence or other progressive neoplasia at the time of the examination * Patient treated with radiotherapy * Patient fluent in French Exclusion Criteria: * Non-consenting patient * History of malignancy, other than treated and cured basal cell or cervical cancer * Patient who has had a salvage surgery other than lymph node removal * Patient with evidence of recurrence or other progressive neoplasia at the time of examination * Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating) * Uncontrolled infectious pathology * Patient under 18 years of age * Patient who is not fluent in French * Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.
Where it's running
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Caen University Hospital
Caen, France Recruiting
Study contacts
- Principal investigator: maxime humbert, MD — University Hospital, Caen
- Study coordinator: Maxime Humbert, MD
- Email: humbert-m@chu-caen.fr
- Phone: 0231064640
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.