Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer (NCT05505188) | Clinical Trial Compass
RecruitingNot Applicable
Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
France120 participantsStarted 2023-03-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.