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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Questionnaire

    Other intervention

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: PopulationOther 1 intervention

Trial outcomes

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

Time frame
Day 0", "Month 6"

Secondary outcomes

1

change, anxiety/depression

with Hospital Anxiety and Depression Scale (HADS), score 0 to 21, higher scores mean a worse outcome

Time frame
Day 0", "Month 6"
2

change, anxiety/depression 1

Montgomery and Asberg Depression Scale (MADRS) questionnaire, score 0 to 60, higher scores mean a worse outcome

Time frame
Day 0", "Month 6"
3

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.

Time frame
Day 0", "Month 6"
4

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.

Time frame
Day 0", "Month 6"

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Caen

Lead sponsor

Centre Francois Baclesse

Collaborator