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

NCT05505188 | Recruiting

• 1 other identifier: 2020-A01894-35
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• change, anxiety/depression

  Day 0", "Month 6"

• change, anxiety/depression 1

  Day 0", "Month 6"

• change, quality of life

  Day 0", "Month 6"

• change, quality of life 1

  Day 0", "Month 6"

• change, fatigue

  Day 0", "Month 6"

Study Arms (1)

Population

OTHER

no arm, single cohort follow-up

Other: Questionnaire

Interventions

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

Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead
• Centre Francois Baclesse: collaborator

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Anxiety Disorders; Chronic Pain; Alcoholism; Signs and Symptoms; Tobacco Use Disorder; Head and Neck Neoplasms; Pain; Behavior, Addictive; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Compulsive Behavior; Impulsive Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• maxime humbert, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime Humbert, MD

CONTACT

0231064640; humbert-m@chu-caen.fr

Emmanuel Babin, PHD

CONTACT

0231064640; babin-e@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: August 17, 2022
• Study Start: March 13, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)