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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05733091
Enrollment
300
Registered
2023-02-17
Start date
2018-12-20
Completion date
2029-12-31
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumors

Brief summary

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

Detailed 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.

Interventions

BEHAVIORALStandard 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

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)through study completion; an average of 1 yearMD 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)

Countries

United States

Contacts

CONTACTShirley Su, MBBS
sysu@mdanderson.org(713) 792-4720
PRINCIPAL_INVESTIGATORShirley Su, MBBS

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026