Nasopharyngeal Carcinoma Post IMRT

NCT02597426 | Active Not Recruiting

• 1 other identifier: 15-9063
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients. This is an observational study that is being done to learn about the long-term symptoms and side effects that survivors of nasopharyngeal cancer may have following radiation treatment. This study will include assessment of patient report outcomes, physician-graded adverse events, neurocognitive assessment and endocrine and hearing testing

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Intensity-Modulated Radiotherapy; Post treatment

Outcome Measures

Primary Outcomes (9)

• Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria)

  • Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death).

  1 Year

• Serum Biochemical Tests for Endocrine Function (fT4, TSH)

  * A single blood test (at same time as the pituitary assessment) will include free thyroxine (fT4; units pmol/L), Thyroid-Stimulating Hormone (TSH; units mIU/L), * Biochemical serum deficiencies in morning testing will be scored individually according to CTCAEv4.03

  1 Year

• Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN)

  * Quality of life as measured by Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) and FACIT-Fatigue ranking individual items from 0= not at all to 4 = very much. * An overall score is reported on the sum of individual items. The FACT-HN consists of the FACT-G (which consists of 27 questions from physical, social, emotional and functional domains) and a 12-item specific head and neck module. A maximum score for the FACT-HN of 144 reflects the best possible quality of life.

  1 Year

• Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue)

  A 13-item specific questionnaire scored using individual items from 0= not at all to 4 = very much collated for a total score.

  1 Years

• Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D)

  A standardized self-reported utility instrument consisting of 5 discrete, 3-level items, and a visual analog scale

  1 YEAR

• Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck)

  • A patient-reported outcome instrument consisting of 28 items, 19 related to common and severe symptoms experienced by cancer patients and 9 specific to head and neck, rated from 0=not present to 10=as bad as you can imagine

  1 YEAR

• Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score)

  A 14 question item scale (7 Anxiety and 7 depression) score 0-3 (each item is individually written) for individual anxiety and depressions scores from 0-21 with validated cut-off points

  1 YEAR

• Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale)

  A validated self-rating scale designed to measure the three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction. A 46-item questionnaire rated pre- and post treatment is scored 1=almost never to 5= almost always. Summary scores are calculated and converted to t-scores.

  1 YEAR

• Cognitive Assessment (Montreal Cognitive Assessment - MoCA)

  A short cognitive assessment testing several cognitive domains - visuospatial, naming, memory, attention, language, abstraction, delayed recall and orientation. A maximum score is 30.

  1 YEAR

Secondary Outcomes (13)

• Association of Radiation Dose with Temporal Lobe Necrosis

  1 Year

• Association of Radiation Dose with Hearing Loss

  1 Year

• Association of Radiation Dose with Cognitive Impairment

  1 Year

• Association of Radiation Dose with Pituitary Dysfunction

  1 Year

• Association of Radiation Dose with Hypothyroidism

  1 Year

Study Arms (2)

Patient

Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT), study will involve Collection of demographic data, endocrine assessment (Pituitary and Thyroid), Patient reported outcomes (Quality of Life Questionnaire), neurocognitive assessment (Behavioral rating scale) and audiology assessment (Assessment of hearing)

Caregiver/Family member

Caregivers for patients who consent to participate. Study will involve Frontal Systems Behavior Scale- FrSBe (behavioral rating scale)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT)

You may qualify if:

• All patients with a previous diagnosis of NPC treated with curative intent who are alive and disease free with a minimum of four years of follow up following completion of treatment
• Received treatment with IMRT
• Age 18 or above, no upper limit
• Ability to comply with the protocol

You may not qualify if:

• History of recurrent nasopharyngeal disease
• A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
• Unable to provide consent

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• John N Waldron, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: November 5, 2015
• Study Start: June 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CA (1)