Clinical trial NCT07001033: Dance Movement Therapy for Radio-oncological Patients
Official title: Integrative, Resource-oriented Short Term Dance Movement Therapy for Radio-oncological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients and Physical Activity
Keywords: Dance Movement Therapy (DMT)
Breast or Prostate cancer and complementary therapy
immunophenotyping
muscle strength and bioelectrical impedance analysis (BIA)
EQ-5D-5L
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and female oncological patients
* Age at least 18 years. No upper age limit
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Written informed consent for participation in the study
* Prior RT received shortly before study inclusion (therapy completed)
* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including

Exclusion Criteria:

* Inability to speak and understand German
* Serious concurrent neurologic or psychiatric disorders: dementia, uncontrolled seizures, psychosis, schizophrenia, neurosis, autism that would interfere with cooperation with the requirements of the trial
* Familial, sociological, or geographical condition that would preclude study compliance (these conditions should be discussed with the patient before registration in the study)
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the study team
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Is pregnant or breastfeeding, or expecting to conceive

Primary outcomes:
measure: Primary objective
timeFrame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Secondary outcomes:
measure: Assessment of muscle strength using the Jamar hand dynamometer
timeFrame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
measure: Assessment of Body Mass Index
timeFrame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
measure: Assessment of percentage proportion in the patient´s body of fat and skeletal muscle using Bioelectrical Impedance Analysis (BIA)
timeFrame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
measure: Assessment of Resting Metabolism (RM) using Bioelectrical Impedance Analysis (BIA)
timeFrame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
measure: Assessment of laboratory parameters and comparison with standard values
timeFrame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
measure: Immunophenotyping-longitudinal immunological measurements using flow cytometry
timeFrame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
measure: Assessment of the side effects of oncological therapy using NCI CTCEA 5.0
timeFrame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
state: Bavaria
Study officials:
References: