Dance-RT-01 investigates the feasibility and effects of Integrative, resource-oriented short term Dance Movement Therapy (DMT) in radio-oncological patients shortly after radiotherapy (RT). The study assesses clinical outcomes, including reduction of fatigue, improvement of quality of life (QoL), functional capacity and body composition. Immunophenotyping and laboratory blood analyses ensure objectively measurable results. Eligible patients participate in short term DMT, that is combined with psychotherapeutic elements. The trial aims to evaluate DMT's potential as a complementary therapy method in cancer care to support recovery and provide a comprehensive understanding of the therapy's effects.
The study is designed as investigator-initiated, prospective, non-randomized feasibility trial and includes radio-oncological patients (ECOG 0-2) who recently completed RT. The primary endpoint is to decide upon the feasibility, as well as identification of specific immunological changes in peripheral blood that contribute to the success of DMT (longitudinal analysis). The benefit for patients is seen in a resource activation after RT and improvement of well-being. Secondary endpoints include functional capacity, measured by maximum grip strength, body composition, assessed through bioelectrical impedance analysis (BIA), assessment of QoL, pain and reduction of fatigue using validated and standardized questionnaires for patient reported outcomes with comparable results. In addition, immunophenotyping is performed. Further laboratory analyses include inflammatory markers, hormone levels, and nutritional biomarkers. These data are analyzed to evaluate correlation of immunological changes with clinical outcomes. Participants complete five weekly DMT sessions (90 minutes each). Each session integrates structured movement exercises, music, and psychotherapeutic elements, that can be tailored depending on each individual patient. The therapy is carried out by a certified therapeutic dance instructor with expertise in radio-oncology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
All participants will be invited to five group meetings at weekly intervals. Each of these therapy sessions will take place with a specific theme. In weeks 1 and 5, data important for the study will be collected once before the short-term DMT and once again at the end of the study. This includes different assessments, laboratory blood tests as well as immunophenotyping. Additionally, patients are requested to complete a questionnaire that addresses QoL. Specific examinations, such as testing the maximal handgrip strength, a BIA and recording Eastern Cooperative Oncology Group (ECOG) performance status are implemented in each of the five meetings.
Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen, Bavaria, Germany
Primary objective
Questionnaire-based (EQ-5D-5L) measurement of well-being containts two main parts: 1) descriptive part in 5 dimentions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimensions have 5 possible answers: no problems, slight problems, moderate problems, severe problems, extreme problems. This is used to define so-called EQ-5D Health States. A total of 3125 different health states can be recorded. Depending on the level, each dimension is assigned a number, resulting in a 5-digit number combination. This 5-digit number can be converted into a score (EQ-5D-5L Index) using a special algorithm that is not publicly available and represents the patient's state of health. An index value of 1 represents the best possible state of health, whil 2) Visual Analogue Scale (VAS) a vertical scale on which the participants indicate their self-related state of health, with 0 representing "The worst health you can imagine" and 100 "The best health you can imagine".
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Assessment of muscle strength using the Jamar hand dynamometer
The subject holds the dynamometer in one hand in line with the forearm and hanging by the thigh. Maximum handgrip strength is then determined without swinging the arm. It is necessary to use the dominate hand for this measurement, because this may help for the interpretation of results. The best of three trials is recorded. The dynamometer must be adjusted for hand size, how successfully this is done will affect the accuracy of the measurement. The values in the standard table (in kg) give a guide to scores expected for adults. They are the average of the best scores of the hand.
Time frame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
Assessment of Body Mass Index
Following parameter will be measured: • Body Mass Index \[kg/m²\] (BMI) including BMI classification
Time frame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
Assessment of percentage proportion in the patient´s body of fat and skeletal muscle using Bioelectrical Impedance Analysis (BIA)
A BIA may provide a non-invasive, rapid method for the assessment of body compartments. For the measurement of a subject, the arms of the subject need to be raised horizontally with the elbows extended and the arms straight at a 90° angle to one's body, holding the display unit. All measurements are performed after the subject had been in supine position for several minutes. All values for the ECW, ICW and TBW compartments are obtained by using the instrument's software option for water volume analysis. Following parameters will be measured: * Body Fat Percentage \[%\] * Skeletal Muscle Percentage \[%\]
Time frame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
Assessment of Resting Metabolism (RM) using Bioelectrical Impedance Analysis (BIA)
A BIA may provide a non-invasive, rapid method for the assessment of body compartments. For the measurement of a subject, the arms of the subject need to be raised horizontally with the elbows extended and the arms straight at a 90° angle to one's body, holding the display unit. All measurements are performed after the subject had been in supine position for several minutes. Following parameters will be measured: • Resting Metabolism (RM) \[kcal\]
Time frame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
Assessment of laboratory parameters and comparison with standard values
complete blood count and white blood cell differential: Erythrocytes (x 10\^6/µl , normal: 3.9 - 5.2), haematocrit (%, normal: 35 - 46), haemoglobin (g/dl 11.8 - 15.5), RDW (%, 11.6 - 16.2), MCH (pg, 26 - 33), MCHC (g Hb/dl, 32 - 36), MCV (fl, 81 - 98), MPV (fl, 7.8 - 11) All x 10\^3/µl normal value in ( ) Leukocytes (4 - 11), basophils (0 - 0.1), eosinophils (0 - 0.5), lymphocytes (1 - 3.5), monocytes (0.1 - 0.9), neutrophils (6 - 7.8) C-Reactives proteine (mg/l, normal: \<5), gamma-GT (U/l, normal: \<40), ferritin (ng/ml, normal: 22-300) , cortisol in serum (µg/dl, normal: 5-25), TSH (mlU/l, normal:0.3-4.00) 25-OH-Vitamin D3 (ng/ml, normal: 30.0-70.0), , vitamin B12 (pg/ml, normal: 211-911), folic acid (ng/ml, normal: 3.89 - 20.0)
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Immunophenotyping-longitudinal immunological measurements using flow cytometry
main immune cell populations: granulocytes, monocytes, NK cells, dendritic cells, T and B cells (all counts per µl of blood)
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Assessment of the side effects of oncological therapy using NCI CTCEA 5.0
Assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
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