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Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer (DIP-CAOS)

Primary Purpose

Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathic Pain focused on measuring Head and neck cancer, pain, Quality of life, Addiction, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Population

    Arm Description

    no arm, single cohort follow-up

    Outcomes

    Primary Outcome Measures

    change, neuropathic pain 1
    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 Outcome Measures

    change, anxiety/depression
    with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome
    change, anxiety/depression 1
    Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome
    change, quality of life
    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.
    change, quality of life 1
    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.
    change, fatigue
    Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue
    change, symptoms related to head and neck cancer
    MD Anderson Symptom Inventory Head and Neck (MDASI-HN) questionnaire, score 0 to 220, higher scores indicating more symptoms
    change, sleep
    question about sleep quality 0-10, higher scores indicating better outcomes
    change, the impact of pain
    short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain
    change, Alcohol Use and Consumption Disorder
    Diagnostic and statistical manual of mental disorders (5th ed.) (DSM5) , questionnaire, score 0 to 115, high scores represent more disorder
    change use of other psychoactive substances
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) alcool questionnaire, score 0 to 39, high scores represent more addiction
    change severity of nicotine addiction
    Fagerström questionnaire, score 0 to 10, high scores represent more addiction

    Full Information

    First Posted
    March 14, 2022
    Last Updated
    August 23, 2022
    Sponsor
    University Hospital, Caen
    Collaborators
    Centre Francois Baclesse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05505188
    Brief Title
    Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
    Acronym
    DIP-CAOS
    Official Title
    Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for Head and Neck Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen
    Collaborators
    Centre Francois Baclesse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuropathic Pain, Anxiety Disorder/Anxiety State, Pain, Chronic, Alcohol Use Disorder, Psychoactive Substance Use, Sleep, Symptoms and Signs, Addiction Nicotine
    Keywords
    Head and neck cancer, pain, Quality of life, Addiction, Depression

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The main objective is to calculate the percentage of patients with neuropathic pain 6 months after the end of the treatments and to analyze the link between this pain and addictions, asthenia, depression, and in a more global way on the quality of life of patients. This evaluation will be done using validated questionnaires and self-questionnaires.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Population
    Arm Type
    Other
    Arm Description
    no arm, single cohort follow-up
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire
    Intervention Description
    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 Outcome Measure Information:
    Title
    change, neuropathic pain 1
    Description
    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
    Time Frame
    Day 0", "Month 6"
    Secondary Outcome Measure Information:
    Title
    change, anxiety/depression
    Description
    with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome
    Time Frame
    Day 0", "Month 6"
    Title
    change, anxiety/depression 1
    Description
    Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome
    Time Frame
    Day 0", "Month 6"
    Title
    change, quality of life
    Description
    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.
    Time Frame
    Day 0", "Month 6"
    Title
    change, quality of life 1
    Description
    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.
    Time Frame
    Day 0", "Month 6"
    Title
    change, fatigue
    Description
    Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue
    Time Frame
    Day 0", "Month 6"
    Title
    change, symptoms related to head and neck cancer
    Description
    MD Anderson Symptom Inventory Head and Neck (MDASI-HN) questionnaire, score 0 to 220, higher scores indicating more symptoms
    Time Frame
    Day 0", "Month 6"
    Title
    change, sleep
    Description
    question about sleep quality 0-10, higher scores indicating better outcomes
    Time Frame
    Day 0", "Month 6"
    Title
    change, the impact of pain
    Description
    short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain
    Time Frame
    Day 0", "Month 6"
    Title
    change, Alcohol Use and Consumption Disorder
    Description
    Diagnostic and statistical manual of mental disorders (5th ed.) (DSM5) , questionnaire, score 0 to 115, high scores represent more disorder
    Time Frame
    Day 0", "Month 6"
    Title
    change use of other psychoactive substances
    Description
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) alcool questionnaire, score 0 to 39, high scores represent more addiction
    Time Frame
    Day 0", "Month 6"
    Title
    change severity of nicotine addiction
    Description
    Fagerström questionnaire, score 0 to 10, high scores represent more addiction
    Time Frame
    Day 0", "Month 6"

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maxime Humbert, MD
    Phone
    0231064640
    Ext
    +33
    Email
    humbert-m@chu-caen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emmanuel Babin, PHD
    Phone
    0231064640
    Ext
    +33
    Email
    babin-e@chu-caen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    maxime humbert, MD
    Organizational Affiliation
    University Hospital, Caen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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