Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer

Trial Title: Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer

NCT ID: NCT05505188

Condition: Neuropathic Pain
Anxiety Disorder/Anxiety State
Pain, Chronic
Alcohol Use Disorder
Psychoactive Substance Use
Sleep
Symptoms and Signs
Addiction Nicotine

Conditions: Official terms:
Head and Neck Neoplasms
Neuralgia
Chronic Pain
Substance-Related Disorders
Alcoholism
Anxiety Disorders
Behavior, Addictive

Conditions: Keywords:
Head and neck cancer
pain
Quality of life
Addiction
Depression

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Questionnaire
Description: Self-questionnaires are completed by the patient at the time of this consultation: - Neuropathic pain: NPSI in screening - Anxiety/depression: HADS in screening - Quality of life: EORTC (QLQC30 and H&N43) - Fatigue: MFI-20 hese self-questionnaires will be retrieved by the Clinical Research Associate (CRA) for verification. Depending on the result of the NPSI questionnaire can be completed to better characterize neuropathic pain. Depending on the result of the HADS, the MADRS questionnaire can be completed to quantify the degree of depression. Individuals diagnosed with neuropathic pain or other depressive symptoms during the 6-month inclusion period will be referred to and managed by specialized practitioners. This assistance will be indicated in follow-up report
Arm group label: Population

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2022

Completion date: September 1, 2024

Lead sponsor:
Agency: University Hospital, Caen
Agency class: Other

Collaborator:
Agency: Centre Francois Baclesse
Agency class: Other

Source: University Hospital, Caen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05505188