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
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
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
NCT ID
NCT05505188
First Posted
March 14, 2022
Last Updated
August 23, 2022
Sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse
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
Learn more about this trial
Predictive and Impact of Pain After 6 Months of Radiotherapy, in Head and Neck Cancer
We'll reach out to this number within 24 hrs