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NCT Number: NCT05505188

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

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.

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Key information

Conditions

Neuropathic Pain Addiction Nicotine Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Anxiety Disorder/Anxiety State Anxiety Disorders Behavior Behavior, Addictive Behavioral Symptoms Chemically-Induced Disorders Chronic Pain Compulsive Behavior Depression Head and Neck Neoplasms Impulsive Behavior Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Psychoactive Substance Use Signs and Symptoms Sleep Substance-Related Disorders Symptoms and Signs Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. change, neuropathic pain 1

    Time frame: Day 0", "Month 6"

    Neuropathic Pain Symptom Inventory (NPSI) questionnaire, score 0 to 10, higher scores mean a worse, score 0 to 100, higher scores mean a worse outcome

Secondary outcomes

  1. change, anxiety/depression

    Time frame: Day 0", "Month 6"

    with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome

  2. change, anxiety/depression 1

    Time frame: Day 0", "Month 6"

    Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome

  3. change, quality of life

    Time frame: Day 0", "Month 6"

    QLQC30 questionnaire of Quality of Life, score 30-100, higher scores indicating better outcomes. the questionnaire measures several factors: physical fitness, professional activity, pain, nutrition, secondary effect, psychological and social status.

  4. change, quality of life 1

    Time frame: Day 0", "Month 6"

    H&N43 questionnaire of Quality of Life, score 43 to 172, higher scores indicating a worse outcomes. The questionnaire measures several factors:secondary effect, self-image, sociability, sexuality.

  5. change, fatigue

    Time frame: Day 0", "Month 6"

    Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue

  6. change, symptoms related to head and neck cancer

    Time frame: Day 0", "Month 6"

    MD Anderson Symptom Inventory Head and Neck (MDASI-HN) questionnaire, score 0 to 220, higher scores indicating more symptoms

  7. change, sleep

    Time frame: Day 0", "Month 6"

    question about sleep quality 0-10, higher scores indicating better outcomes

  8. change, the impact of pain

    Time frame: Day 0", "Month 6"

    short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain

  9. change, Alcohol Use and Consumption Disorder

    Time frame: Day 0", "Month 6"

    Diagnostic and statistical manual of mental disorders (5th ed.) (DSM5) , questionnaire, score 0 to 115, high scores represent more disorder

  10. change use of other psychoactive substances

    Time frame: Day 0", "Month 6"

    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) alcool questionnaire, score 0 to 39, high scores represent more addiction

  11. change severity of nicotine addiction

    Time frame: Day 0", "Month 6"

    Fagerström questionnaire, score 0 to 10, high scores represent more addiction

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Babin, PHD

CONTACT

[email protected]

0231064640 ext. +33

Maxime Humbert, MD

CONTACT

[email protected]

0231064640 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Centre Francois Baclesse

Registry information

Official study title

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

Acronym: DIP-CAOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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