Thyroid Associated Ophthalmopathy
Conditions
Keywords
radiation therapy
Brief summary
Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss. Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP. Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares. This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.
Detailed description
The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT). The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy. By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease. Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.
Interventions
RADIATIONShort course radiation therapy
5 daily radiation treatments
RADIATIONStandard course radiation therapy
10 daily radiation treatments
Sponsors
Mahidol University
Janjira Petsuksiri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In this study, both participants and researchers are aware of the treatment administered due to the necessity for close monitoring of treatment outcomes and side effects by radiation oncologists and ophthalmologists.
Intervention model description
Phase 2 randomized control trial comparing between standard radiation therapy arm (20 Gy in 10 fractions) and experimental radiation therapy arm (10 Gy in 5 fractions)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient with active moderate to severe thyroid eye disease with a CAS \> 4 with/ without diplopia before starting IVMP * Patient with poor response to 3 doses of IVMP (CAS drop \< 1) หรือ CAS score \> 3 after 3 doses of IVMP * Patients with diplopia after 3 doses of IVMP * Patients with Graves' Ophthalmopathy who have maintained euthyroidism * Non-pregnant adults (aged 35 years or older)
Exclusion criteria
* Individuals with severe hypertension or diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Activity Score (CAS) change | 6 months after initiation of IVMP | To evaluate the non-inferiority of outcomes in terms of the patient's proportion of converting from active (CAS \> 4) to inactive eye disease (CAS \<3) with CAS drop \> 2 points, following orbital radiotherapy in combination with IVMP, comparing standard and reduced-dose orbital radiotherapy CAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in diplopia | 6 months after initiation of IVMP | To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy |
| change in quality of life | 6 months after initiation of IVMP | To compare the difference in Graves' ophthalmopathy quality of life (GO-QOL) scores (Thai version) between standard and reduced-dose orbital radiotherapy. The total QOL scores range from 0 to 100 with higher scores indicating a better health status. |
| muscle and retrobulbar fat volume change | 6 months after initiation of IVMP | To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy |
| Visual acuity (VA) | 6 months after initiation of IVMP | -To compare the differences in visual acuity (logMAR) change after standard and reduced-dose orbital radiotherapy |
| Visual field (VF) | 6 months after initiation of IVMP | \- To compare the differences of Humphrey's visual field (mean deviation) change after standard and reduced-dose orbital radiotherapy |
| Radiation toxicities | 6 months after initiation of IVMP | To compare the summation of the Radiation Therapy Oncology Group (RTOG) toxicity scores (including dry eye, eye pain, keratitis, eyelid, conjunctiva, lacrimal gland, cornea, iris and skin toxicities) after standard and reduced-dose orbital radiotherapy. The RTOG gradings range from grade 0 to grade 4 in each item. The total toxicity scores range from 0-34, with a higher score indicating more severe side effects. |
Countries
Thailand
Contacts
Primary ContactJanjira Petsuksiri, M.D.
Backup ContactWajana Thaweerat, M.D.
Outcome results
None listed