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

NCT04528420 | Recruiting

• 1 other identifier: CHB19.01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 7

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

radiochemotherapy; nutrition; support care; early management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessing the impact of multimodal management on overall survival and progression-free survival 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

  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

  3 months post treatment

• Assessing the impact of multimodal management on average weight loss

  18 months post treatment

• Medico-economic analysis of multimodal management using the cost-utility method

  18 months post treatment

Study Arms (2)

Optimised arm

EXPERIMENTAL

Patients will be taken care of early and optimally way.

Other: optimised management

Standard arm

NO INTERVENTION

Patients will be monitored as in standard practice

Interventions

optimised management OTHER

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.

Optimised arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (7)

CHU Amiens

Amiens, France

RECRUITING

CH Beauvais

Beauvais, France

RECRUITING

Clinique du Parc

Caen, France

NOT YET RECRUITING

Centre Guillaume le Conquérant

Le Havre, France

RECRUITING

CHRU Lille

Lille, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

CH Saint-Quentin

Saint-Quentin, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Sébastien Thureau, MD,PhD

  Centre Henri Becquerel

  STUDY DIRECTOR

Central Study Contacts

Florian Clatot, MD,PhD

CONTACT

+33232082231; florian.clatot@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 27, 2020
• Study Start: November 26, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)