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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— OPTINECK  

Official title:

Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04528420
• Other study ID #: CHB19.01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2020
• Source: Centre Henri Becquerel
• Contact: Florian Clatot, MD,PhD
• Phone: +33232082231
• Email: florian.clatot[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.	Proportion of patients with at least 5% reduction in weight at 3 months post-treatment compared to the inclusion consultation	3 months post treatment
Secondary	Assessing the impact of multimodal management on overall survival and progression-free survival at 18 months post-treatment	Overall and progression-free survival rate at 18 months post-treatment	18 months post treatment
Secondary	Assessing the impact of multimodal management on the percentage of patients receiving the full treatment as planned	Percentage of patients who received all the treatment as planned	1 month
Secondary	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	Number of patients who level 3 analgesics has been prescribed	3 months post treatment
Secondary	Assessing the impact of multimodal management on average weight loss	Average of difference of weight at the end of the study and weight at the inclusion	18 months post treatment
Secondary	Medico-economic analysis of multimodal management using the cost-utility method	Cost-utility ratio in each arm	18 months post treatment