Geriatric Support Strategies for Head and Neck Cancer

Recruiting at 5 trial locations

Overseen By Nancy Lee, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Geriatrician consultation, Telemedicine inability, Proton therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Geriatric Co-Management, Geriatric Guided Supportive Care for head and neck cancer?

Research highlights the importance of geriatric assessment and a multidisciplinary team approach in managing older patients with head and neck cancer, but evidence specifically supporting the effectiveness of Geriatric Co-Management and Geriatric Guided Supportive Care is limited. A study found that geriatric assessment-driven interventions did not significantly improve survival, functional, or nutritional status in older patients with head and neck cancer. ^{1 2 3 4 5}

Is Geriatric Support Strategies for Head and Neck Cancer safe for elderly patients?

There is limited safety data specifically for Geriatric Support Strategies in elderly head and neck cancer patients, but older patients often face higher risks of treatment side effects and may need more supportive care. Adjustments in treatment plans are often necessary to reduce potential adverse effects. ^{3 6 7 8 9}

How does the treatment for elderly head and neck cancer patients differ from other treatments?

This treatment is unique because it focuses on a comprehensive geriatric assessment to tailor the approach specifically for older patients, considering their overall health, cognitive function, and personal circumstances, which is not typically emphasized in standard treatments for head and neck cancer. ^{1 2 3 10 11}

Research Team

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My cancer is in my mouth, throat, voice box, or the area below my pharynx.

I will undergo a 6-7 week course of radiation and chemotherapy.

Able to read and understand English

Exclusion Criteria

I am undergoing or have undergone proton therapy.

I am not currently on any standard treatments or experimental therapy trials.

I cannot use telemedicine and must visit the clinic in person.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation

Consultation with a geriatrician or oncologist to review eRFA results and create a management plan for geriatric deficits

1 week

1 visit (in-person or virtual)

Treatment

Participants receive head and neck radiation and chemotherapy with either geriatric co-management or geriatric guided supportive care

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Geriatric Co-Management
• Geriatric Guided Supportive Care

Trial Overview 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.

Participant Groups

Group I: geriatric guided supportive care Experimental Treatment 1 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-management Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Older Adult With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma: Knowledge Gaps and Future Direction in Assessment and Treatment. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Special considerations for elderly patients with head and neck cancer during the COVID-19 pandemic. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Management of elderly patients with head and neck cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

G-8 indicates overall and quality-adjusted survival in older head and neck cancer patients treated with curative radiochemotherapy. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Geriatric Assessment-Driven Interventions on Survival and Functional and Nutritional Status in Older Patients with Head and Neck Cancer: A Randomized Controlled Trial (EGeSOR). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Functional and cognitive impairment, social environment, frailty and adverse health outcomes in older patients with head and neck cancer, a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Elderly patients with squamous cell carcinoma of the head and neck and the benefit of multimodality therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A specific approach for elderly patients with head and neck cancer. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of older patients with head and neck cancer: a review. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Use of the Geriatric-8 screening tool to predict prognosis and complications in older adults with head and neck cancer: A prospective, observational study. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Palliative Care and End-of-Life Issues in Elderly Cancer Patients With Head and Neck Cancer. [2022]