Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 2:11 PM
Study NCT ID:
NCT07001033
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2025-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dance Movement Therapy for Radio-oncological Patients
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
Study Overview
Official Title:
Integrative, Resource-oriented Short Term Dance Movement Therapy for Radio-oncological Patients
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DANCE-RT-01
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: