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Completed

NCT Number: NCT02025062

Comprehensive Geriatric Assessment and Head and Neck Elderly Cancer Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGA and geriatric follow-up

Other

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

Primary outcomes

  1. 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

    Time frame: 6 months after the randomization

Secondary outcomes

  1. progression-free survival

    Time frame: 6 month, 12 month and 24 month after the randomization

  2. death

    Time frame: 6 month , 12 month and 24 month after the randomization

  3. total duration of hospitalization

    Time frame: 6 month, 12 month and 24 month after the randomization

  4. quality of life (QLQC30, HN35)

    Time frame: 6 month , 12 month and 24 month after the randomization

  5. costs of treatment

    Time frame: 6 month , 12 month and 24 month after the randomization

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cancéropôle Ile De France
  • National Cancer Institute (NCI)

Registry information

Official study 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

Acronym: EGéSOR

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Dec 31, 2013
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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