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NCT05239000 Clinical Trial

A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Pilot Randomized Clinical Trial of Geriatric Comanagement or Geriatric Guided Supportive Care for Older Patients With Head and Neck Cancer Receiving Radiation and Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05239000
Other study ID # 22-016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2022
Est. completion date February 2025

Study information
Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact Kaveh Zakeri, MD
Phone 848-225-6435
Email zakerik@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The researchers are doing this study to see whether geriatric co-management or geriatric guided supportive care are good approaches for managing side effects in older patients who have head and neck cancer and are receiving chemoradiation therapy. This study will provide valuable information about different ways to manage side effects in older patients receiving chemoradiation therapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age = 65 - Pathologically (histologically or cytologically) diagnosis of head and neck cancer of oral cavity, oropharynx, larynx, or hypopharynx - Patient will receive a 6 to 7 week course of intensity modulated radiation therapy and concurrent chemotherapy either in definitive or post-operative setting - Able to read and understand English - Able to provide informed consent Exclusion Criteria: - Patients who have previously consulted with or are followed by a geriatrician - Inability to use telemedicine if unable to present to clinic visits in person - Inability to complete the eRFA (patient is unable to comprehend or answer questions included on the eRFA) - Treatment with proton therapy - Patients on therapeutic clinical trials of experimental therapies or those not receiving standard of care

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• geriatric co-management
Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy.
• geriatric guided supportive care
Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of patients with hospital admission (geriatric co-management arm) The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm. 2 years
Primary proportion of patients with hospital admission (geriatric guided supportive care arm) The proportion of patients hospitalized during the course of chemoradiation either at MSKCC or an outside hospital will be assessed for each arm. 2 years
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