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Recruiting

NCT Number: NCT05733091

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Shirley Su, MBBS

CONTACT

[email protected]

713-792-4720

Shirley Su, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age ≥ 18 years
  • Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
  • Ability to understand and willingness to sign written informed consent

Exclusion criteria

  • History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
  • Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
  • Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.

Treatment and study plan

Standard of Care

Behavioral

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

Primary outcomes

  1. MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)

    Time frame: through study completion; an average of 1 year

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley Su, MBBS

CONTACT

[email protected]

(713) 792-4720

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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