Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Draw and Questionaire.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (LDRT)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change of circulating immune cells of treated patients by deep immunophenotyping. [Time frame: up to 3 month after completion of RT]
Secondary outcome measures (4)
- Change of joint pain intensity of the treated patients. [Time frame: up to 9 month after completion of RT]
- Change of functional capacity in daily life of the treated patients [Time frame: up to 9 month after completion of RT]
- Change of health-related quality of life [Time frame: up to 9 month after completion of RT]
- description of pain quality [Time frame: up to 9 month after completion of RT]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- Department of Radiation Oncology, Universitätsklinikum Erlangen — Erlangen
Publications
- Donaubauer AJ, Becker I, Weissmann T, Frohlich BM, Munoz LE, Gryc T, Denzler M, Ott OJ, Fietkau R, Gaipl US, Frey B. Low Dose Radiation Therapy Induces Long-Lasting Reduction of Pain and Immune Modulations in the Peripheral Blood - Interim Analysis of the IMMO-LDRT01 Trial. Front Immunol. 2021 Oct 12;12:740742. doi: 10.3389/fimmu.2021.740742. eCollection 2021. PMID 34712229
Identifiers
NCT: NCT02653079 · IMMO-LDRT01