RecruitingNot ApplicableNCT05505188

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


Sponsor

University Hospital, Caen

Enrollment

120 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French study is looking at how pain develops and persists in patients with head and neck cancer who are receiving radiotherapy. The goal is to identify which patients are most at risk for long-term pain after treatment so they can be supported earlier. **You may be eligible if...** - You have been diagnosed with a first-time head and neck cancer requiring radiotherapy - You are over 18 and have given written consent - You have not had previous radiotherapy - You speak French fluently - Your cancer is histologically confirmed and there are no signs of spread or recurrence at enrollment **You may NOT be eligible if...** - You have previously had another cancer (other than treated basal cell skin cancer or cervical cancer) - You have had major cancer surgery beyond lymph node removal - Your WHO performance score is 3 or higher (you are significantly limited in daily activity) - Your life expectancy is 3 months or less Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQuestionnaire

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


Locations(1)

Caen University Hospital

Caen, France

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NCT05505188


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