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

Study acronym: DIP-CAOS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 25, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 1, 2023 to Mar 1, 2026
    • Start date changed from estimate of Sep 1, 2022 to Mar 13, 2023
    • Study sites: 0 to 1
    • Study completion date: Sep 1, 2024 to Sep 1, 2026
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05505188
Lead Sponsor University Hospital, Caen
Collaborators: Centre Francois Baclesse
Conditions
(from sponsor)
Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder, Psychoactive Substance Use, Sleep, Symptoms and Signs, Addiction Nicotine
Related terms Alcoholism, Anxiety Disorders, Behavior, Addictive, Chronic Pain, Depression, Head and Neck Neoplasms, Neuralgia, Pain, Signs and Symptoms, Tobacco Use Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov