Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT

Chronic Inflammatory Disorder Clinical Trial

— IMMO-LDRT01  

Official title:

Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (LDRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02653079
• Other study ID #: IMMO-LDRT01
• Status: Recruiting
• Start date: June 2016
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Benjamin Frey, PhD
• Phone: +49 9131 85 44248
• Email: benjamin.frey[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients suffering from chronic degenerating diseases are often treated by a plethora of NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many patients are refractory to this treatment and suffer from chronic pain over years, leading to a worsening of the quality of live. The mobilization of these patients is one main goal in the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is applied since more than one century for the local treatment of chronic degenerating joint diseases. The success of the treatment was described by many retrospective as well as pattern of care studies, respectively.

Local (only at the painful joint) low dose irradiation of the chronic patients results in most patients in a significantly reduced pain, not only direct after the therapy, but also lasting for more than 12 month in many cases. The patients experience enhanced mobility and increased quality of life. The molecular and cellular processes leading to the pain reduction are just fragmentarily analyzed. Our group revealed that macrophages are key players in radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of radiation showed a reduced inflammatory capacity and attenuated an inflammatory microenvironment. Besides macrophages further immune cells are most likely involved in reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.

The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining over 30 immune cell subsets and additionally their activation status. Further, biodosimetry will be performed with the whole-blood samples to get hints about dose that the immune cells are exposed to. This will be performed with national and international co-operation partners.

The IMMO-LDRT01 study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the LDRT affects besides local cells in the irradiated area also the systemic inflammatory response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suffering and diagnosed for:

• painful shoulder syndrome (periarthritis humeroscapularis)

• painful elbow syndrome (Epicondylopathia humeri)

• benign achillodynia

• benign calcaneodynia

• arthosis (finger- , rhiz-, gon-, and anklearthrosis

• arthritis (gon- and anklearthrosis)

• Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen.

• Age at least 18 years

Exclusion Criteria:

• patients who are suffering or had suffered from any malignant diseases

• fertile patients who refuse effective contraception during study treatment

• persistent drug and/or alcohol abuse

• patients not able or willing to behave according to study protocol

• patients in care

• patients that are not able to speak German

Related Conditions & MeSH terms

• Chronic Inflammatory Disorder
• Joint Diseases

Intervention

Other:
• Blood Draw and Questionaire
The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw from patients at several time points during and after low dose radiation therapy.

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, Universitätsklinikum Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of circulating immune cells of treated patients by deep immunophenotyping.	Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers. The analyses are conducted at time points before (day 0) and after low dose radiation therapy (day 21): before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment.	up to 3 month after completion of RT
Secondary	Change of joint pain intensity of the treated patients.	Analysis of the pain by VAS (visaul Analog Scale; 0 - lowest pain intensity, 10 highest pain intensity) at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment.	up to 9 month after completion of RT
Secondary	Change of functional capacity in daily life of the treated patients	Analysis of the functional capacity in daily life by FFbH-R (Funktionsfragebogen Hannover, 100% normal to 10 % nearly complete restricted) questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment.	up to 9 month after completion of RT
Secondary	Change of health-related quality of life	Analysis of the health-related quality of life by EQ5DL (health index value) questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment.	up to 9 month after completion of RT
Secondary	description of pain quality	Analysis of the pain by descriptive questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT. This scheme is repeated if patient receives additional round of LDRT for relapse treatment.	up to 9 month after completion of RT