NCT05505188

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Questionnaire	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

Timeline

• Start date: 2023-03-13
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2022-08-17
• Last updated: 2025-07-25

Locations

1 site across 1 country: France