Back to resultsThe Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TSH, T3, T4 and thyroid gland DVH
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring hypothyroidism, radiotherapy, head and neck cancer
Eligibility Criteria
Inclusion Criteria:
- Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy
Exclusion Criteria:
- Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy
Sites / Locations
- Department of clinical oncology and nuclear medicine, Cairo university
Outcomes
Primary Outcome Measures
The the incidence of hypothyroidism
Measuring the thyroid function tests
Secondary Outcome Measures
The risk factors of hypothyroidism
Defining the risk factors of hypothyroidism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03699098
Brief Title
The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up
Official Title
The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a retrospective study with long term follow up to evaluate the incidence, timing and risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy.
Detailed Description
For any patient, fixation was done by a thermoplastic mask. CT scan was done at 3mm thickness for the head and neck region. CT images were transferred to the planning system. Three-dimensional conformal RT, intensity-modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT) was created. All patients were irradiated with once-daily fractionation at 1.8-2.0 Gy/d with 6-MV photon beams for five days a week. The gross target volume (GTV) was treated with a dose of 70Gy and the lymphatic site (CTV) and areas of high risk microscopic disease (CTV) including lymph nose levels received a radiation dose ranging from 54-66 Gy according to its risk. PTV is a circumferential margin of 5mm around CTV.
Thyroid function parameters:
The patient's serum T4, T3 and TSH levels, were measured during follow up. Clinical hypothyroidism is defined as the increase in TSH above 5.0mIu/ml with a decrease in free thyroxine levels (free T4) in the serum while elevated TSH with normal free T4 levels was labeled as subclinical hypothyroidism .As per institutional values, the normal values intervals of T4 level (7- 25 PMOL/L), T3( 1.5-7 PMOL/L),TSH (0.2-5 mIu/L).
The median time to onset of hypothyroidism was defined as the time interval between completion of radiotherapy and first abnormal recorded T3/T4/TSH value.
For all treated patients, thyroid gland was delineated and by reviewing the DVH, the V45, V50, V55, V60, V65 and V70 which means the volume of the thyroid gland receiving 45 Gy, 50 Gy, 55Gy, 60 Gy and 70 Gy respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
hypothyroidism, radiotherapy, head and neck cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
TSH, T3, T4 and thyroid gland DVH
Intervention Description
measuring thyroid functions and DVH parameters of thyroid gland
Primary Outcome Measure Information:
Title
The the incidence of hypothyroidism
Description
Measuring the thyroid function tests
Time Frame
8 months
Secondary Outcome Measure Information:
Title
The risk factors of hypothyroidism
Description
Defining the risk factors of hypothyroidism
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy
Exclusion Criteria:
Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy
Facility Information:
Facility Name
Department of clinical oncology and nuclear medicine, Cairo university
City
Cairo
ZIP/Postal Code
11311
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up
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