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

Sleep Clinical Trial

— DIP-CAOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05505188
• Other study ID #: 2020-A01894-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Caen
• Contact: Maxime Humbert, MD
• Phone: 0231064640
• Email: humbert-m[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Addiction Nicotine
• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorder/Anxiety State
• Anxiety Disorders
• Behavior, Addictive
• Chronic Pain
• Disease
• Head and Neck Neoplasms
• Neuralgia
• Neuropathic Pain
• Pain, Chronic
• Psychoactive Substance Use
• Sleep
• Substance-Related Disorders
• Symptoms and Signs

Intervention

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 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre Francois Baclesse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0", "Month 6"
Secondary	change, anxiety/depression	with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome	Day 0", "Month 6"
Secondary	change, anxiety/depression 1	Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome	Day 0", "Month 6"
Secondary	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.	Day 0", "Month 6"
Secondary	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.	Day 0", "Month 6"
Secondary	change, fatigue	Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue	Day 0", "Month 6"
Secondary	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	Day 0", "Month 6"
Secondary	change, sleep	question about sleep quality 0-10, higher scores indicating better outcomes	Day 0", "Month 6"
Secondary	change, the impact of pain	short pain questionnaire in French (QCD), score 0 to 120, high scores represent more impact of pain	Day 0", "Month 6"
Secondary	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	Day 0", "Month 6"
Secondary	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	Day 0", "Month 6"
Secondary	change severity of nicotine addiction	Fagerström questionnaire, score 0 to 10, high scores represent more addiction	Day 0", "Month 6"