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

Predictive and Impact of Pain at 6 Months in Patients Treated With Radiotherapy for 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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Neuropathic Pain; Alcohol Use Disorder; Pain, Chronic; Psychoactive Substance Use; Addiction Nicotine; Symptoms and Signs; Anxiety Disorder/Anxiety State
• Intervention / Treatment: Other: Questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime Humbert, MD; Phone Number: +33 0231064640; Email: humbert-m@chu-caen.fr
• Study Contact Backup: Name: Emmanuel Babin, PHD; Phone Number: +33 0231064640; Email: babin-e@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Population; no arm, single cohort follow-up

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change, anxiety/depression	with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome	Day 0", "Month 6"
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"
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"
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"
change, fatigue	Multidimensional Fatigue Inventory (MFI-20) questionnaire, score 20 to 100, high scores represent more fatigue	Day 0", "Month 6"
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"
change, sleep	question about sleep quality 0-10, higher scores indicating better outcomes	Day 0", "Month 6"
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"
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"
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"
change severity of nicotine addiction	Fagerström questionnaire, score 0 to 10, high scores represent more addiction	Day 0", "Month 6"

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Centre Francois Baclesse
• Investigators: Principal Investigator: maxime humbert, MD, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Depression; pain; Quality of life; Addiction; Head and neck cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chemically-Induced Disorders; Alcohol-Related Disorders; Compulsive Behavior; Impulsive Behavior; Anxiety Disorders; Alcoholism; Chronic Pain; Substance-Related Disorders; Neuralgia; Head and Neck Neoplasms; Behavior, Addictive
• Other Study ID Numbers: 2020-A01894-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No