Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
NCT ID: NCT04528420
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
138 participants
INTERVENTIONAL
2020-11-26
2028-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival.
While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prognostic Impact of Tumor Growth Velocity in Head and Neck Squamous Cell Carcinoma Treated by Radio(Chemo)Therapy
NCT02990936
Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
NCT00424255
Treatment of Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT01086826
Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC
NCT00162708
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT07190755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Optimised arm
Patients will be taken care of early and optimally way.
optimised management
At the inclusion , the patient will benefit from an early consultation with a nutritionist, a pain doctor and a social worker.
During the preparation phase for radiotherapy the patient will benefit from weekly consultations with a pain nurse and a dietician.
During the radiotherapy the patient will be weighed daily and have an assessment of their nutritional needs and a weekly consultation with a pain nurse and dietician and then twice a month until three months post-radiotherapy.
Standard arm
Patients will be monitored as in standard practice
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
optimised management
At the inclusion , the patient will benefit from an early consultation with a nutritionist, a pain doctor and a social worker.
During the preparation phase for radiotherapy the patient will benefit from weekly consultations with a pain nurse and a dietician.
During the radiotherapy the patient will be weighed daily and have an assessment of their nutritional needs and a weekly consultation with a pain nurse and dietician and then twice a month until three months post-radiotherapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Worl Health Organisation score \< 2,
* Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,
* Having signed the informed consent,
* Affiliate or beneficiary of a social protection scheme.
Exclusion Criteria
* History of radiotherapy for head and neck cancer,
* Contraindications to cisplatin,
* Pregnant or breastfeeding woman,
* Protected major (under guardianship or curatorship),
* Patient participating in a therapeutic study
* Patient unable to understand the study for any reason or to comply with the constraints of the trial
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Henri Becquerel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sébastien Thureau, MD,PhD
Role: STUDY_DIRECTOR
Centre Henri Becquerel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens
Amiens, , France
CH Beauvais
Beauvais, , France
Clinique du Parc
Caen, , France
Centre Guillaume le Conquérant
Le Havre, , France
CHRU Lille
Lille, , France
Centre Henri Becquerel
Rouen, , France
CH Saint-Quentin
Saint-Quentin, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Alexandre COUTTE, MD
Role: primary
Hanifa AMMARGUELLAT, MD
Role: primary
Emmanuel Sevin, MD
Role: primary
Laurent Martin, MD
Role: primary
François MOUAWAD, MD
Role: primary
Farid BELKHIR, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHB19.01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.