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Recruiting NCT05505188

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

No phase Interventional Neuropathic Pain Anxiety Disorder/Anxiety State Pain, Chronic Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer

Overview

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.

Interventions

  • 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 ca

Primary outcome measures

  • change, neuropathic pain 1 [Time frame: Day 0", "Month 6"]
Secondary outcome measures (11)
  • change, anxiety/depression [Time frame: Day 0", "Month 6"]
  • change, anxiety/depression 1 [Time frame: Day 0", "Month 6"]
  • change, quality of life [Time frame: Day 0", "Month 6"]
  • change, quality of life 1 [Time frame: Day 0", "Month 6"]
  • change, fatigue [Time frame: Day 0", "Month 6"]
  • change, symptoms related to head and neck cancer [Time frame: Day 0", "Month 6"]
  • change, sleep [Time frame: Day 0", "Month 6"]
  • change, the impact of pain [Time frame: Day 0", "Month 6"]
  • change, Alcohol Use and Consumption Disorder [Time frame: Day 0", "Month 6"]
  • change use of other psychoactive substances [Time frame: Day 0", "Month 6"]
  • change severity of nicotine addiction [Time frame: Day 0", "Month 6"]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Caen University Hospital — Caen

Identifiers

NCT: NCT05505188 · 2020-A01894-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗