Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis

NCT ID: NCT05887284

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2028-12-31

Brief Summary

IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.

Detailed Description

The prevalence of chronic degenerative and inflammatory disorders, such as osteoarthritis, is constantly rising. As not all patients do respond adequately to the standard therapies, alternative treatment options such as low dose radiation therapy (LDRT) has gained further importance. LDRT is known to induce a long-lasting pain reduction, while having few side effects. Nonetheless, the detailed biological and immunological modes of action remain mostly elusive. In addition, there is a lack in placebo controlled randomised controlled trials (RCTs) proofing the pain-relieving effects of LDRT. So, the prospective, placebo-controlled, double-blind, randomized IMMO-LDRT02 trial to investigate the clinical efficacy of LDRT in the treatment of arthrosis should close this gap. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale (VAS) and identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group (IMMO-LDRT01 trial; ClinicalTrials.gov Identifier: NCT02653079).

Conditions

Arthrosis; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low dose Radiation Therapy

In the test group, patients receive radiotherapy with six fractions of 0.5 Gy each over a period of 3 weeks, with 2 doses applied per week (total dose 3.0 Gy). After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients from the test group receive another irradiation series with six fractions of 0.5 Gy each according to the same schedule as before (total dose 3.0 Gy and in sum with the first series 6.0 Gy).

Group Type: EXPERIMENTAL

low dose radiotherapy (0.5 Gy)

Intervention Type: RADIATION

12 times 0.5 Gy

Mock Radiation Therapy

In the control group, patients receive sham irradiation with six fractions of 0.0 Gy each over a period of 3 weeks, with 2 treatments per week. After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients in the control group, on the other hand, now also receive a radiotherapy with six fractions of 1.0 Gy each over a period of 3 weeks with 2 fractions per week (total dose 6.0 Gy).

Group Type: PLACEBO_COMPARATOR

mock radiation treatment

Intervention Type: RADIATION

6 times 0.0 Gy

low dose radiotherapy (1.0 Gy)

Intervention Type: RADIATION

6 times 1.0 Gy

Interventions

low dose radiotherapy (0.5 Gy)

12 times 0.5 Gy

Intervention Type: RADIATION

mock radiation treatment

6 times 0.0 Gy

Intervention Type: RADIATION

low dose radiotherapy (1.0 Gy)

6 times 1.0 Gy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):

• Finger and wrist osteoarthritis
• Elbow arthrosis
• Shoulder arthrosis
• Knee arthrosis
• Ankle and foot joint arthrosis
• First time application of low-dose radiotherapy (LDRT) of the affected joint.
• Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care

Exclusion Criteria

• Patients with tumor diseases
• People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy
• Persistent drug, medication or alcohol abuse
• Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.
• Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.
• Earlier radiation therapy for treatment of cancer

• Minimum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Ott, Prof. Dr

Role: STUDY_DIRECTOR

Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Benjamin Frey, PD Dr.-Ing.

Role: PRINCIPAL_INVESTIGATOR

Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Thomas Weissmann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Rainer Fietkau, Prof. Dr.

Role: STUDY_CHAIR

Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Locations

Department of Radiation Oncology, Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Benjamin Frey, PD Dr.-Ing.

Role: CONTACT

benjamin.frey@uk-erlangen.de

+49 9131 85 ext. 44248

Anna-Jasmina Donaubauer, Dr.

Role: CONTACT

anna-jasmina.donaubauer@uk-erlangen.de

+49 9131 85 ext. 44925

Facility Contacts

Benjamin Frey, Dr.-Ing.

Role: primary

benjamin.frey@uk-erlangen.de

+49 9131 85 ext. 44248

Anna Donaubauer, M.Sc.

Role: backup

anna-jasmina.donaubauer@uk-erlangen.de

+49 9131 85 ext. 32311

Other Identifiers

IMMO-LDRT02

Identifier Type: -

Identifier Source: org_study_id