Clinical trial NCT02025062: Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinomas (HNSCCs)
Keywords: head and neck squamous cell carcinomas (HNSCCs)
elderly
cancer
comprehensive geriatric assessment
functional status
malnutrition
survival
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Cancéropole Ile De France
First posted: 2013-12-31
Enrollment: 499
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Context: The survival of elderly patients with head and neck squamous cell carcinomas (HNSCC) cancer is greatly reduced compared to younger subjects. Several explanations have been proposed : a competitive comorbidity, a more frequent refusal of standard therapy or the choice of a suboptimal treatment due to fear of toxicities. The comprehensive geriatric assessment (CGA) may influence the decision-making process and help for managing elderly patients with head and neck cancer. The CGA 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.

Hypotheses: We postulate that the CGA and the geriatric follow-up improves 1) the therapeutic decision-making process thanks to a better assessment of the patient's functional reserve and its capacity to support or not the treatment, and 2) the overall survival, the functional status and the nutritional status of elderly patients with HNSCC because of a more appropriate treatment and a personalized medical follow-up after surgery and/or radiotherapy and/or chemotherapy or more rarely targeted therapy, with adjustment of treatments and management of comorbidities and/or treatment complications.

Main objective: To assess the impact of the CGA and the geriatric follow-up on the overall survival, the functional status and the nutritional status of elderly patients with HNSCC.

Secondary objectives: To assess the impact of the CGA on the therapeutic decision, the toxicity and/or complications of treatment, the complete realization of treatment, the autonomy, the institutionalization, the total hospitalization stay, the quality of life of elderly patients with HNSCCs and the costs.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 6 months after the randomization
Secondary outcomes:
measure: progression-free survival
timeFrame: 6 month, 12 month and 24 month after the randomization
measure: death
timeFrame: 6 month , 12 month and 24 month after the randomization
measure: total duration of hospitalization
timeFrame: 6 month, 12 month and 24 month after the randomization
measure: quality of life (QLQC30, HN35)
timeFrame: 6 month , 12 month and 24 month after the randomization
measure: costs of treatment
timeFrame: 6 month , 12 month and 24 month after the randomization
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eléna Paillaud, MD / PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier intercommunal de Créteil
name: Lydia Brugel, MD / PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abstracts 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.
citation: Homma 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.
citation: Brugel 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.