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

NCT ID: NCT05505188

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2026-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Population

no arm, single cohort follow-up

Group Type: OTHER

Questionnaire

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

maxime humbert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Caen University Hospital

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maxime Humbert, MD

Role: CONTACT

humbert-m@chu-caen.fr

0231064640 ext. +33

Emmanuel Babin, PHD

Role: CONTACT

babin-e@chu-caen.fr

0231064640 ext. +33

Other Identifiers

2020-A01894-35

Identifier Type: -

Identifier Source: org_study_id