NCT05505188Recruiting
Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Head and neck cancers are a source of complications and after-effects related to the disease and treatment. These cancers and their treatment alter the quality of life of patients and generate pain with physical and psychological components. Chronic pain affects 36% of patients at 6 months and 30% after this period. These pains are responsible for the consumption of level II and III analgesics in 53% of these patients. At the same time, after the end of treatment, nearly a quarter of patients continued to smoke and half still consumed alcohol at least twice a week. The hypothesis of this research is to investigate the correlation between pain and the continuation of addictions, the occurrence of depressive states, asthenia and the alteration of the patients' global quality of life. The investigators propose a two-center prospective cohort study to evaluate this hypothesis at 6 months after radiotherapy treatment. This study is planned to include 120 patients with a first head and neck cancer whit radiotherapy as part of their treatment sequence. The expected duration of inclusion is 18 months. The identification of factors affecting survival, quality of life and patient compliance is essential to determine appropriate management, particularly by creating appropriate therapeutic education programs.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 14 Mar 2022
- Start date
- 13 Mar 2023
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- Head and neck cancer
- NCT number
- NCT05505188
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 13 Mar 2023 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who has had a salvage surgery other than lymph node removal
- Patient who has had previous mutilating surgery (causing sequelae of swallowing and eating)
Other illness
- History of malignancy, other than treated and cured basal cell or cervical cancer
- Patient with a psychiatric pathology that could disrupt the study or prevent the interpretation of the results.
Age
- Patient under 18 years of age
Other
- Non-consenting patient
- Patient with evidence of recurrence or other progressive neoplasia at the time of examination
- Uncontrolled infectious pathology
- Patient who is not fluent in French
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Caen University Hospital Coordinator of this site? Confirm its status | Caen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.