Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors

Tumors Clinical Trial

Official title:

Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733091
• Other study ID #: PA18-0969
• Secondary ID: NCI-2023-01436
• Status: Recruiting
• Start date: December 20, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Shirley Su, MBBS
• Phone: (713) 792-4720
• Email: sysu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

Description:

Objectives:

• To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.

• To estimate the prevalence of health promotion behaviors during skull base tumor survivorship

• To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.

• To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.

• To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.

2. Age = 18 years

3. Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy

4. Ability to understand and willingness to sign written informed consent

Exclusion criteria:

1. History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.

2. Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.

3. Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.

Related Conditions & MeSH terms

• Skull Base Neoplasms
• Tumors

Intervention

Behavioral:
• Standard of Care
Standard of care assessment of their function including pituitary hormone lab draws, audiogram hearing test, eye exam, teeth and jaw exam (in trismus clinic) and speech and swallowing evaluation

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)	MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) is a disease specific PRO instrument validated for patients with head and neck cancer. It is the most commonly utilized instrument in the head and neck cancer population, of which sinonasal and nasopharyngeal tumors are disease subsites.; Score scale from 0 (symptom has been present) to 10 (the symptom was as bad as you can imagine it could be)	through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center