PROs Following Low-dose Irradiation for Osteoarthritis (PRO-LO)

Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry

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).

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Olivia Roberts; Phone Number: 984-974-8441; Email: olivia_roberts@med.unc.edu
• Study Contact Backup: Name: Victoria Xu; Phone Number: 984-974-8744; Email: victoria_xu@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • UNC Chapel Hill
      • Principal Investigator: Theodore Yanagihara, MD, PhD
      • Contact: Victoria Xu; Phone Number: 984-974-8744; Email: victoria_xu@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 60 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 β-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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with osteoarthritis receiving radiation treatment; Patients with osteoarthritis receiving standard of care radiation treatment at UNC Radiation Oncology clinic. Radiation dose and fractionation prescription is at the physician's discretion. Typically, this prescription is delivered in 6 fractions, every other day, over 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion	The investigators will use the visual analog 0-10 pain scale (VAPS) and compare the baseline pre-radiation measurement to that measured at 3 months post radiation.	Baseline and 3 months post RT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Pain Scale (VAPS) Score Over Time	The investigators will use the visual analog 0-10 pain scale (VAPS), where 0 is no pain and 10 is the worst physical pain imaginable, and compare the baseline pre-radiation measurement to that assessed at 6 weeks, 6 and 12 months, and yearly up to 5 years post radiation (RT). Higher scores indicate a worse outcome.	Baseline up to 5 years post RT
Change in Hip Joint-Specific Outcome Over Time	Joint-specific outcomes measures scales will include the Hip Injury and Osteoarthritis Outcome Score (HOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. Investigators will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Change in Knee Joint-Specific Outcome Over Time	Joint-specific outcomes measures scales will include the Knee Injury and Osteoarthritis Outcome Score (KOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time	Joint-specific outcomes measures scales will include the Disability of Arm Shoulder and Hand (DASH). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Change in Foot Joint-Specific Outcome Over Time	Joint-specific outcomes measures scales will include the Foot & Ankle Disability Index Score (FADI). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Change in NSAID Dosage	The investigator will compare NSAID doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.	Baseline up to 5 years post RT
Change in Opioid Dosage	The investigator will compare opioid doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.	Baseline up to 5 years post RT
Change in NSAID Frequency	The investigator will compare NSAID frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Change in Opioid Frequency	The investigator will compare opioid frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.	Baseline up to 5 years post RT
Invasive Procedures	The investigator will report invasive procedures to treat the radiated joint experienced by each subject for the treatment of OA.	Up to 5 years post RT

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Theodore Yanagihara, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; radiation therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 22-3256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No