NCT04528420: OPTINECK

Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer

Recruiting now NA Last updated 2 January 2026

What this trial tests

NA trial testing optimised management in Squamous Cell Carcinoma of Head and Neck in 138 participants. Currently enrolling.

Timeline

26 November 2020

Primary endpoint
1 December 2027

1 June 2028

Quick facts

Lead sponsor	Centre Henri Becquerel
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	138
Start date	26 November 2020
Primary completion	1 December 2027
Estimated completion	1 June 2028
Sites	7 locations across France

Drugs / interventions tested

• optimised management

Conditions studied

• Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →

Sponsor

Centre Henri Becquerel — full company profile →

Who can join

Adults 18 to 75, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.