Predicting and understanding pain six months after radiotherapy for head and neck cancer
Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT05505188 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Caen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.