Henri Becquerel Center
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.
Squamous Cell Carcinoma of Head and Neck
optimised management
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 138 participants |
| Masking : | NONE |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck |
| Actual Study Start Date : | 2020-09-01 |
| Estimated Primary Completion Date : | 2023-12-01 |
| Estimated Study Completion Date : | 2025-06-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 75 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
CHU Amiens
Amiens, France,
Not yet recruiting
CH Beauvais
Beauvais, France,
Not yet recruiting
Park Clinic
Caen, France,
Not yet recruiting
William the Conqueror Center
Le Havre, France,
Not yet recruiting
CHRU Little
Lille, France,
Not yet recruiting
Henri Becquerel Center
Rouen, France,
Not yet recruiting
CH Saint-Quentin
Saint-Quentin, France,