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Geriatric Support Strategies for Head and Neck Cancer

N/A
Recruiting
Led By Kaveh Zakeri, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically diagnosed with head and neck cancer of oral cavity, oropharynx, larynx, or hypopharynx
Will receive a 6 to 7 week course of intensity modulated radiation therapy and concurrent chemotherapy either in definitive or post-operative setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing different ways to manage side effects in older patients with head and neck cancer receiving chemoradiation therapy.

Who is the study for?
This trial is for individuals aged 65 or older with a confirmed diagnosis of head and neck cancer who are about to undergo chemoradiation therapy. Participants must be able to give informed consent, read and understand English, and commit to a 6-7 week course of treatment. Those already consulting with a geriatrician, unable to use telemedicine, or on experimental therapy trials are excluded.Check my eligibility
What is being tested?
The study compares two methods: geriatric co-management versus geriatric guided supportive care in managing side effects for older patients receiving chemoradiation for head and neck cancers. It aims to determine which approach is more effective during the treatment period.See study design
What are the potential side effects?
While specific side effects aren't listed here, both approaches aim to manage typical side effects from chemoradiation such as fatigue, nausea, mouth sores, difficulty swallowing, dry mouth/skin changes due to radiation; the exact experiences may vary by patient.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in my mouth, throat, voice box, or the area below my pharynx.
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I will undergo a 6-7 week course of radiation and chemotherapy.
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I am 65 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of patients with hospital admission (geriatric co-management arm)
proportion of patients with hospital admission (geriatric guided supportive care arm)

Trial Design

2Treatment groups
Experimental Treatment
Group I: geriatric guided supportive careExperimental Treatment1 Intervention
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. The automated report also includes suggested interventions for each deficit (e.g, referral to physical therapy. For instance, automated suggestions for a patient with a history of falls include consultation with physical therapy, neurologic evaluation, a home safety evaluation, or use of supportive devices. Automated recommendations for patient with high level of distress or depression include referral to psychiatry or social work, involvement in a cancer support group, or additional time spent addressing questions and fears. The oncology team will review the automated report from the eRFA and create an intervention plan prior to initiation of head and neck radiation and chemotherapy.
Group II: geriatric co-managementExperimental Treatment1 Intervention
Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy. Consultation with geriatricians can occur in-person or remotely via telemedicine. During this visit, the geriatrician will review the results of the eRFA and create a plan to manage geriatric deficits. Geriatric co-management involves optimization of comorbid conditions, management of polypharmacy, and supportive care referrals to address geriatric deficits. Geriatricians also work in conjunction with the treating oncologists to ensure patients have appropriate pain management and bowel regimens. Additional follow up visits after the initial consultation are at the discretion of the geriatrician may vary between patients depending on the clinical need.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,841 Total Patients Enrolled
Kaveh Zakeri, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
96 Total Patients Enrolled

Media Library

geriatric co-management Clinical Trial Eligibility Overview. Trial Name: NCT05239000 — N/A
Head and Neck Cancers Research Study Groups: geriatric co-management, geriatric guided supportive care
Head and Neck Cancers Clinical Trial 2023: geriatric co-management Highlights & Side Effects. Trial Name: NCT05239000 — N/A
geriatric co-management 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period of this trial still active?

"Clinicaltrials.gov indicates that this study is actively seeking participants, with the original posting taking place on February 3rd 2022 and the most recent update occurring March 21st of the same year."

Answered by AI

Are there any locales that are conducting this clinical experiment in the region?

"This study is presently enrolling participants at 6 different medical centres, situated in Middletown, Commack and Uniondale as well other locales. To reduce the burden of travelling for patients who choose to partake in this trial, it's best to select a location closest to you."

Answered by AI

To what extent is this research project being populated with participants?

"Affirmative. Information available on clinicaltrials.gov shows that this medical trial, initially posted on February 3rd 2022 is presently enrolling patients at 6 different sites in need of 40 volunteers."

Answered by AI
~10 spots leftby Feb 2025