Clinical trial NCT05505188: Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
Official title: Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Anxiety Disorder/Anxiety State
Pain, Chronic
Alcohol Use Disorder
Psychoactive Substance Use
Sleep
Symptoms and Signs
Addiction Nicotine
Keywords: Head and neck cancer
pain
Quality of life
Addiction
Depression
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Centre Francois Baclesse
First posted: 2022-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The main objective is to calculate the percentage of patients with neuropathic pain 6 months after the end of the treatments and to analyze the link between this pain and addictions, asthenia, depression, and in a more global way on the quality of life of patients. This evaluation will be done using validated questionnaires and self-questionnaires.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: change, neuropathic pain 1
timeFrame: Day 0", "Month 6"
Secondary outcomes:
measure: change, anxiety/depression
timeFrame: Day 0", "Month 6"
measure: change, anxiety/depression 1
timeFrame: Day 0", "Month 6"
measure: change, quality of life
timeFrame: Day 0", "Month 6"
measure: change, quality of life 1
timeFrame: Day 0", "Month 6"
measure: change, fatigue
timeFrame: Day 0", "Month 6"
measure: change, symptoms related to head and neck cancer
timeFrame: Day 0", "Month 6"
measure: change, sleep
timeFrame: Day 0", "Month 6"
measure: change, the impact of pain
timeFrame: Day 0", "Month 6"
measure: change, Alcohol Use and Consumption Disorder
timeFrame: Day 0", "Month 6"
measure: change use of other psychoactive substances
timeFrame: Day 0", "Month 6"
measure: change severity of nicotine addiction
timeFrame: Day 0", "Month 6"
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: maxime humbert, MD
role: PRINCIPAL_INVESTIGATOR
References: