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Nasopharyngeal Carcinoma Post IMRT

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ClinicalTrials.gov Identifier: NCT02597426
Recruitment Status : Active, not recruiting
First Posted : November 5, 2015
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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


Condition or disease
Nasopharyngeal Carcinoma

Detailed 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.


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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria) [ Time Frame: 1 Year ]
    • 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).

  2. Serum Biochemical Tests for Endocrine Function (fT4, TSH) [ Time Frame: 1 Year ]
    • 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

  3. Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN) [ Time Frame: 1 Year ]
    • 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.

  4. Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue) [ Time Frame: 1 Years ]
    A 13-item specific questionnaire scored using individual items from 0= not at all to 4 = very much collated for a total score.

  5. Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D) [ Time Frame: 1 YEAR ]
    A standardized self-reported utility instrument consisting of 5 discrete, 3-level items, and a visual analog scale

  6. Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck) [ Time Frame: 1 YEAR ]
    • 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

  7. Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score) [ Time Frame: 1 YEAR ]
    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

  8. Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale) [ Time Frame: 1 YEAR ]
    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.

  9. Cognitive Assessment (Montreal Cognitive Assessment - MoCA) [ Time Frame: 1 YEAR ]
    A short cognitive assessment testing several cognitive domains - visuospatial, naming, memory, attention, language, abstraction, delayed recall and orientation. A maximum score is 30.


Secondary Outcome Measures :
  1. Association of Radiation Dose with Temporal Lobe Necrosis [ Time Frame: 1 Year ]
    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.

  2. Association of Radiation Dose with Hearing Loss [ Time Frame: 1 Year ]
    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

  3. Association of Radiation Dose with Cognitive Impairment [ Time Frame: 1 Year ]
    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.

  4. Association of Radiation Dose with Pituitary Dysfunction [ Time Frame: 1 Year ]
    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

  5. Association of Radiation Dose with Hypothyroidism [ Time Frame: 1 Year ]
    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

  6. Association between dysphagia and quality of life [ Time Frame: 1 Year ]
    Correlation between dysphagia and FACT-HN score and EQ-D5

  7. Association between hearing and quality of life [ Time Frame: 1 Year ]
    Correlation between dysphagia and and FACT-HN score and EQ-D5

  8. Association between hearing and quality of life [ Time Frame: 1Year ]
    Correlation between degree of hearing loss (on audiology) and FACT-HN score and EQ-D5

  9. Association between cranial neuropathy and quality of life [ Time Frame: 1Year ]
    Correlation between degree of cranial neuropathy and FACT-HN score and EQ-D5

  10. Association between neurocognitive score (MoCA) and quality of life [ Time Frame: 1 Year ]
    Correlation between Montreal Cognitive Assessment Score and FACT-HN score and EQ-D5

  11. Association between frontal functioning and quality of life [ Time Frame: 1 Year ]
    Correlation between FrSBE (Frontal Systems Behaviour) and FACT-HN score and EQ-D5

  12. Association between pituitary function and quality of life [ Time Frame: 1 Year ]
    Correlation between pituitary function and FACT-HN score and EQ-D5

  13. Association between thyroid function and quality of life [ Time Frame: 1 Year ]
    Correlation between thyrrhoid function and FACT-HN score and EQ-D5



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597426


Locations
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Canada, Ontario
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: John N Waldron, MD University Health Network--Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02597426     History of Changes
Other Study ID Numbers: UHN REB 15-9063-CE
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Keywords provided by University Health Network, Toronto:
Nasopharyngeal Carcinoma
Intensity-Modulated Radiotherapy
Post treatment

Additional relevant MeSH terms:
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Nasopharyngeal 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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases