Clinical trial NCT05705947: PROs Following Low-dose Irradiation for Osteoarthritis
Official title: Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Keywords: Osteoarthritis
radiation therapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged 60 or above, who are receiving radiation treatment at UNC Radiation Oncology for Osteoarthritis are the intended study population.

Brief summary: The goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (OA) patients receiving standard of care radiation therapy (RT).

Detailed description: This is a single-institution, single-arm, prospective, observational study of patients with osteoarthritis who are being treated with standard of care radiation therapy (RT). The purpose of this non-interventional study is to systematically collect data related to patient reported outcomes (pain, function, quality of life, toxicity) with the goal of optimizing approaches to management with radiation therapy and clinical care during follow up. The primary endpoint of this study is a change in visual analog pain scale (VAPS) at 3 months post radiation and a variety of secondary endpoints are aimed at assessing disease control, patient function, avoidance of invasive surgery, and toxicity. Participants will complete patient-reported outcome surveys for pain and joint-specific functional assessment.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* Established diagnosis of OA of at least 1 joint
* Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater.
* Will undergo radiation as part of their standard of care for OA.
* At least 55 years old
* Ability to read and speak English.

Exclusion Criteria:

* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).
* Estimated life expectancy less than 6 months.
* Radiation treatment for shoulder OA
* Patient weight greater than 550lbs

Primary outcomes:
measure: Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
timeFrame: Baseline and 3 months post RT
Secondary outcomes:
measure: Change in Visual Analog Pain Scale (VAPS) Score Over Time
timeFrame: Baseline up to 5 years post RT
measure: Change in Hip Joint-Specific Outcome Over Time
timeFrame: Baseline up to 5 years post RT
measure: Change in Knee Joint-Specific Outcome Over Time
timeFrame: Baseline up to 5 years post RT
measure: Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time
timeFrame: Baseline up to 5 years post RT
measure: Change in Foot Joint-Specific Outcome Over Time
timeFrame: Baseline up to 5 years post RT
measure: Change in NSAID Dosage
timeFrame: Baseline up to 5 years post RT
measure: Change in Opioid Dosage
timeFrame: Baseline up to 5 years post RT
measure: Change in NSAID Frequency
timeFrame: Baseline up to 5 years post RT
measure: Change in Opioid Frequency
timeFrame: Baseline up to 5 years post RT
measure: Invasive Procedures
timeFrame: Up to 5 years post RT
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Theodore Yanagihara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: