Nasopharyngeal Carcinoma Post IMRT

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Comprehensive Prospective Cross Sectional Study on the Late Effects of Radical Chemoradiotherapy in Nasopharyngeal Carcinoma Patients Treated in the Intensity-Modulated Radiotherapy Era

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02597426
• Other study ID #: UHN REB 15-9063-CE
• Status: Active, not recruiting
• Start date: June 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

This study is designed to provide comprehensive cross sectional information on the late toxicities following radical chemoradiotherapy in nasopharyngeal carcinoma in patients who are disease free with a minimum of four years follow-up and who were treated with contemporary radiotherapy techniques (IMRT). This is an observational cross-sectional study which will aim to define the late effects in this population, investigating both well known toxicities identified from studies using earlier radiotherapy techniques (2D and 3D radiotherapy) as well as toxicities which have not been well defined in the current literature and which may be under-recognized and under treated (pituitary function and neurocognitive outcomes).

This study will assess survivors at a single time point four years after completion of their treatment who are disease free. This comprehensive review will include demographic data, clinical assessment, biochemical assessment of hormonal (pituitary and thyroid) function, patient reported outcomes, and quality of life and neurocognitive questionnaires. This study will attempt to comprehensively review these toxicities in a contemporary patient group with modern radiotherapy techniques in an attempt to bridge the gap between current recommended follow up protocols and the actual challenges faced by long term survivors. Some of these factors will be correlated with radiation doses received by the patient to inform on radiation dose thresholds for appropriate toxicities (hypothalamic-pituitary, thyroid, temporal lobe necrosis, neurocognitive performance). Patients will be offered follow-up, if required with appropriate personnel if appropriate, including neuropsychology, endocrinology and otoloryngology.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Association of Radiation Dose with Temporal Lobe Necrosis	Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the temporal lobe and risk of temporal lobe necrosis.	1 Year
Secondary	Association of Radiation Dose with Hearing Loss	Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the cochlear and vestibulocochlear nerve and risk of hearing loss	1 Year
Secondary	Association of Radiation Dose with Cognitive Impairment	Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the temporal lobe, brain and hippocampus and risk of neurocognitive impairment.	1 Year
Secondary	Association of Radiation Dose with Pituitary Dysfunction	Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the pituitary and risk of hypopituitarism	1 Year
Secondary	Association of Radiation Dose with Hypothyroidism	Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the thyroid gland and risk of hypothyroidism	1 Year
Secondary	Association between dysphagia and quality of life	Correlation between dysphagia and FACT-HN score and EQ-D5	1 Year
Secondary	Association between hearing and quality of life	Correlation between dysphagia and and FACT-HN score and EQ-D5	1 Year
Secondary	Association between hearing and quality of life	Correlation between degree of hearing loss (on audiology) and FACT-HN score and EQ-D5	1Year
Secondary	Association between cranial neuropathy and quality of life	Correlation between degree of cranial neuropathy and FACT-HN score and EQ-D5	1Year
Secondary	Association between neurocognitive score (MoCA) and quality of life	Correlation between Montreal Cognitive Assessment Score and FACT-HN score and EQ-D5	1 Year
Secondary	Association between frontal functioning and quality of life	Correlation between FrSBE (Frontal Systems Behaviour) and FACT-HN score and EQ-D5	1 Year
Secondary	Association between pituitary function and quality of life	Correlation between pituitary function and FACT-HN score and EQ-D5	1 Year
Secondary	Association between thyroid function and quality of life	Correlation between thyrrhoid function and FACT-HN score and EQ-D5	1 Year