NCT05887284

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jul 2023Dec 2028

First Submitted

Initial submission to the registry

May 5, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

3.3 years

First QC Date

May 5, 2023

Last Update Submit

February 12, 2024

Conditions

ArthrosisOsteoarthritis

Keywords

low dose radiotherapyLDRT

Outcome Measures

Primary Outcomes (2)

  • Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo.

    Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group.

    Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

Secondary Outcomes (12)

  • Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • Analysis of the efficacy of LDRT against placebo in modulating patient's well-being.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • Analysis of the clinical efficacy of LDRT against placebo in shoulders.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • Analysis of the clinical efficacy of LDRT against placebo in knees.

    Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).

  • +7 more secondary outcomes

Study Arms (2)

Low dose Radiation Therapy

EXPERIMENTAL

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).

Radiation: low dose radiotherapy (0.5 Gy)

Mock Radiation Therapy

PLACEBO COMPARATOR

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).

Radiation: mock radiation treatmentRadiation: low dose radiotherapy (1.0 Gy)

Interventions

low dose radiotherapy (0.5 Gy)RADIATION

12 times 0.5 Gy

Low dose Radiation Therapy
mock radiation treatmentRADIATION

6 times 0.0 Gy

Mock Radiation Therapy
low dose radiotherapy (1.0 Gy)RADIATION

6 times 1.0 Gy

Mock Radiation Therapy

Eligibility Criteria

Age39 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Oliver Ott, Prof. Dr

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

    STUDY DIRECTOR

  • Benjamin Frey, PD Dr.-Ing.

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

    PRINCIPAL INVESTIGATOR

  • Thomas Weissmann, Dr.

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

    PRINCIPAL INVESTIGATOR

  • Rainer Fietkau, Prof. Dr.

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

    STUDY CHAIR

Central Study Contacts

Benjamin Frey, PD Dr.-Ing.

CONTACT

+49 9131 85benjamin.frey@uk-erlangen.de

Anna-Jasmina Donaubauer, Dr.

CONTACT

+49 9131 85anna-jasmina.donaubauer@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind clinical trial.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 2, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)