Clinical trial NCT04528420: Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
Official title: Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: radiochemotherapy
nutrition
support care
early management
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment.

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.


Eligibility criteria: Inclusion Criteria:

* Male or female, over 18 and under 75 years of age,
* 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 other neoplastic disease less than 2 years old or progressive,
* 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

Primary outcomes:
measure: Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Assessing the impact of multimodal management on overall survival and progression-free survival at 18 months post-treatment
timeFrame: 18 months post treatment
measure: Assessing the impact of multimodal management on the percentage of patients receiving the full treatment as planned
timeFrame: 1 month
measure: Assessing the impact of multimodal management on the percentage of patients receiving level 3 analgesics during radio-chemotherapy and up to 3 months post-treatment
timeFrame: 3 months post treatment
measure: Assessing the impact of multimodal management on average weight loss
timeFrame: 18 months post treatment
measure: Medico-economic analysis of multimodal management using the cost-utility method
timeFrame: 18 months post treatment
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Beauvais
country: France
facility: CH Beauvais
city: Caen
country: France
facility: Clinique du Parc
city: Le Havre
country: France
facility: Centre Guillaume le Conquérant
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Quentin
country: France
facility: CH Saint-Quentin
Study officials:
affiliation: Centre Henri Becquerel
name: Sébastien Thureau, MD,PhD
role: STUDY_DIRECTOR
References: