Clinical trial · Interventional
Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients
Impact of Comprehensive Geriatric Assessment on Malnutrition, Functional Status and Survival in Elderly Patients With Head and Neck Squamous Cell Carcinomas (HNSCCs): a Randomized Controlled Multicenter Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological management, nutritional and functional status, and support needed at home. To assess the overall needs of the elderly patients, an assessment known as "comprehensive geriatric assessment" (CGA) can be performed by a geriatrician with extensive testing and questionnaires. This assessment is long and requires an experienced geriatrician. It leads to the development of an individualized treatment plan (physiotherapy, psychological follow-up, support at home, nutritional management ...) and follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA utility has been studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed improving survival and maintaining the elderly at home.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinomas (HNSCCs) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGA and geriatric follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- In the control arm, patients are followed-up by the head-and-neck physician, oncologist and radiotherapists and did not benefit of Comprehensive Geriatric Assessment.
- type
- EXPERIMENTAL
- label
- Comprehensive Geriatric Assessment
- description
- The CGA (Comprehensive Geriatric Assessment) is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up.
- interventionNames
- Other: CGA and geriatric follow-up
Primary outcomes (1)
- measure
- Composite criteria, including: death; autonomy (if loss of two points or more in the Activity of Daily Living (ADL) compared with the initial ADL); nutritional status (if weight loss of 10% or more compared to the initial weight at diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * patients aged 65 years old and over (modified by amendment n 2 -1/07/2014) * macroscopical lesions suggesting an cancerous tumor in head and neck awaiting pathology confirmation; * support in one of ENT/Maxilla-facial surgery departments in the study; * patients insured by a social security; * patients informed of the study, and having given his non opposition verbally. Exclusion Criteria: * patients deprived of liberty or under legal protection; * presence of psychological, family, socials or geographic condition(s) that may interfere with the proper conduct of the study; * personal history of head and neck cancer except single surgery for squamos cell carcinoma without additional treatment (without curietherapy or RT) with a free interval of at least 5 years (modified by amendment n 2 -1/07/2014) * patients with cancerous tumor of sinus and salivary glands
References
Publications (4)
- BACKGROUNDAbstracts of the 6th European Congress of Oto-Rhino-Laryngology Head and Neck Surgery, June 30-July 4, 2007, Vienna, Austria. Eur Arch Otorhinolaryngol. 2007 Jun;264 Suppl 1:S1-354. doi: 10.1007/s00405-007-0343-8. No abstract available. PMID 17558509
- BACKGROUNDHomma A, Sakashita T, Oridate N, Suzuki F, Suzuki S, Hatakeyama H, Mizumachi T, Taki S, Fukuda S. Importance of comorbidity in hypopharyngeal cancer. Head Neck. 2010 Feb;32(2):148-53. doi: 10.1002/hed.21158. PMID 19536763
- DERIVEDLafont C, Paillaud E, Bertolus C, Baron M, Caillet P, Bouvard E, Laurent M, Salvan D, Chaumette L, de Decker L, Piot B, Barry B, Raynaud-Simon A, Sauvaget E, Minard A, Anota A, Panjo H, Brugel L, Canoui-Poitrine F. Geriatric assessment and quality of life for 2 years in older patients with head and neck cancer. J Natl Cancer Inst. 2024 May 8;116(5):758-763. doi: 10.1093/jnci/djae027. PMID 38335935
- DERIVEDBrugel L, Laurent M, Caillet P, Radenne A, Durand-Zaleski I, Martin M, Baron M, de Kermadec H, Bastuji-Garin S, Canoui-Poitrine F, Paillaud E. Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR). BMC Cancer. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427. PMID 24923533