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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Other: optimised management

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
    • Contact: Alexandre COUTTE, MD
  • Beauvais, France
    • CH Beauvais
    • Contact: Hanifa AMMARGUELLAT, MD
  • Caen, France
    • Clinique du parc
    • Contact: Emmanuel SEVIN, MD
  • Le Havre, France
    • Centre Guillaume Le Conquerant
    • Contact: Laurent MARTIN, MD
  • Lille, France
    • CHRU Lille
    • Contact: Francois Mouawad, MD
  • Rouen, France
    • Centre Henri Becquerel
    • Contact: Sebastien Thureau, MD,PhD; Phone Number: +033276673030; Email: sebastien.thureau@chb.unicancer.fr
  • Saint-Quentin, France
    • CH Saint-Quentin
    • Contact: Farid BELKHIR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimised arm; Patients will be taken care of early and optimally way.	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.
No Intervention: Standard arm; Patients will be monitored as in standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Medico-economic analysis of multimodal management using the cost-utility method	Cost-utility ratio in each arm	18 months post treatment

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Study Director: Sébastien Thureau, MD,PhD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: nutrition; radiochemotherapy; support care; early management
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CHB19.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No