Graft Vs Host Disease Clinical Trial
— IRENE-GOfficial title:
IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
The IRENE-G trial is a randomized controlled study that aims to investigate the effect of a supervised resistance exercise program (2x/week for 24 weeks) in combination with a nutritional intervention on physical performance/frailty in patients with GvHD symptoms treated with high dose steroids.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | February 28, 2025 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Existing or new diagnosis of acute or chronic GvHD treated with systemic steroid therapy (=0,5 mg/kg/day) - Sufficient German language skills - Willing/ able to train at the provided exercise facilities or online twice a week - Willing/ able to take part in the scheduled testing - Capacity to consent - Signed informed consent Exclusion Criteria: - Any physical or mental conditions that would hamper the adherence to the training and/or nutritional program or the completion of the study procedures - Heart insufficiency > NYHA III or uncertain arrhythmia - Uncontrolled hypertension - Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl) - Reduced standing or walking ability - Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL) - Any other comorbidities that preclude participation in the exercise programs |
Country | Name | City | State |
---|---|---|---|
Germany | Heidelberg University Hospital | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg | Deutsche José Carreras Leukämie-Stiftung |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to week 24 in Physical performance, as measured by the Short Physical Performance Battery (SPPB) | Physical Performance will be assessed with the Short Physical Performance Battery (SPPB). The SPPB is based on three timed tasks: 4-meter walking speed test, standing balance (feet side-by-side, semi-tandem, full tandem) and sit-to-stand test. Participants score on each component of the battery. Each task is scored out of 4. The sum of the three assessments comprised the final SPPB score with a possible range from 0 to 12. A higher score represents a higher level of function, while lower level indicate lower level of function. Change = (Week 24 Score - Baseline Score). The SPPB is a well-established instrument for the measurement of physical performance, commonly used is elderly patients both in hospital and community setting. | up to 24 weeks (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Submaximal endurance performance, assessed with the 6 minute walk test | The 6 minute walk test will be used to determine the submaximal endurance capacity. The test measures the distance an individual is able to walk over a total of six minutes. The goal is for the individual to walk as far as possible within six minutes. | up to 24 weeks (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Muscle strength performance, as measured by Hand-held dynamometer | A hand-held dynamometer will be applied to assess maximal voluntary isometric muscle contraction in Newton meters in 6 muscle groups (knee and elbow flexors and extensors, hip flexors and abductors). Muscle groups will be assessed bilaterally for their isometric power. Change = (Week 24 value - Baseline value) | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Muscle volume, assessed with ultrasound measurement | Ultrasound measurement will be performed to determine the thickness and cross sectional area of both vastus lateralis muscles as well as subcutaneous adipose tissue thickness. Change = (Week 24 value - Baseline value) | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Nutritional Status | The nutritional status will be determined using the Nutritional Risk Screening (NRS 2002), lab parameters (e.g. albumin and total protein), hand-grip strength. | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 Health related Quality of life, as measured by the EORTC QLQ-C30 | Quality of life will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symtom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 24 Score - Baseline Score) | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in high-dose chemotherapy and stem cell transplantation-related symptoms and problems, as measured by the EORTC QLQ-HDC 29 | The EORTC QLQ-HDC 29 is a 29-item quality of life questionnaire, which has been developed to elicit patient's experience of symptoms and problems during and after high-dose chemotherapy and stem cell transplantation (57). It consists of 6 multi-item scales (gastro-intestinal side-effects, worry/anxiety, impact on family, body image, sexuality, in-patient issues) and 8 single-item (skin problems, fever/chills, urinary frequency, aches or pain in bones, taking regular drugs, finishing things, ability to have children, experience helping to distinguish what is important in life) questions. Scores range from 0 to 100 with higher score representing higher levels of problems. Change = (Week 24 Score - Baseline Score) | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Cancer-related Fatigue, as measured by the EORTC QLQ-FA12 | Fatigue will be assessed via the EORTC QLQ-FA 12 questionnaire, which is an internationally validated phase IV module of the European Organisation for Research and Treatment of Cancer. The module assesses physical, cognitive and emotional aspects of cancer-related fatigue. It is composed of 12 questions, 10 unidirectional and 2 criteria variables which measure the extent to which fatigue interferes with daily activities and social life. Scores range from 0 to 100. Higher scores represent a higher level of fatigue symptomatology. Change = (Week 24 Score - Baseline Score) | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in patient-perceived GVHD symptom bother, as measured by the modified 7-day Lee Chronic-versus-Host Disease Symptom Scale | The modified 7-day Lee Chronic-versus-Host Disease Symptom Scale will be used to capture the GvHD-specific symptom burden. It is a 28 item, 7-domain symptom scale (skin, eyes, mouth, lung, nutrition, energy and psych). Patients will report their level of symptom bother over a period of 7 days on a 5-point Likert scale. | up to week 24 (& 6 month follow-up) | |
Secondary | Change from baseline to week 24 in Functional Status determined with the Karnofsky performance scale | The Karnofsky performance scale (KPS) will be applied to assess functional status of a patient. The KPS is a 11-point rating scale, which ranges from normal functioning (100%) to dead (0%). The scale is widely used due to its psychometric properties and recommended in clinical assessments. | up to week 24 (& 6 month follow-up) |
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