Cancer Patients and Physical ActivityDANCE-RT-01NCT07001033
Dance Movement Therapy for Radio-oncological Patients
A study testing Dance Movement Therapy (DMT) in people with Cancer Patients and Physical Activity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients and Physical Activity
- What is being tested?
- Dance Movement Therapy (DMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2025to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen, Bavaria, 91054
About this study
Official title: Integrative, Resource-oriented Short Term Dance Movement Therapy for Radio-oncological Patients
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.
Read the 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.
- Conditions
- Cancer Patients and Physical Activity
- Being tested
- Dance Movement Therapy (DMT)
- Keywords
- Dance Movement Therapy (DMT), Breast or Prostate cancer and complementary therapy, immunophenotyping, muscle strength and bioelectrical impedance analysis (BIA), EQ-5D-5L
- Medical subject headings
- Motor Activity, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Movement Therapy (DMT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DMT arm | Other | All patients receive a dance movement therapy intervention once a week for 90 minutes over a period of five weeks, which is combined with psychotherapeutic content. The therapy is carried out by one specially trained DMT therapist with experience in radiooncology.
The structure of the sessions is designed in such a way that there is a 15-minute starting phase with a mindfulness exercise and opening flash, followed by a 50-minute active phase in which special topic are carried out:
Therapy sessions and topics:
1. Introduction. Get to know. Encounter.
2. Body awareness and dealing with one's own limits.
3. Social relationships. Proud. Becoming aware of your own resources.
4. "Cage of emotions". Release.
5. Conclusion. Reflection and transfer to everyday life. Farewell. Receives: Behavioral: Dance Movement Therapy (DMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Secondary outcomes (7)
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.
Measured: 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
Measured: 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 [%]
Measured: 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]
Measured: 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)
Measured: 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)
Measured: 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
Measured: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start22 Feb 2025
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients and Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001033
- Sponsor's protocol ID
- FAU 24-505-B
- Acronym
- DANCE-RT-01
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative, Resource-oriented Short Term Dance Movement Therapy for Radio-oncological Patients
- ClinicalTrials.gov ID
- NCT07001033
- Acronym / sponsor ID
- DANCE-RT-01 / FAU 24-505-B
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMT arm | Other | Behavioral: Dance Movement Therapy (DMT)All patients receive a dance movement therapy intervention once a week for 90 minutes over a period of five weeks, which is combined with psychotherapeutic content. The therapy is carried out by one specially trained DMT therapist with experience in radiooncology. The structure of the sessions is designed in such a way that there is a 15-minute starting phase with a mindfulness exercise and opening flash, followed by a 50-minute active phase in which special topic are carried out: Therapy sessions and topics: 1. Introduction. Get to know. Encounter. 2. Body awareness and dealing with one's own limits. 3. Social relationships. Proud. Becoming aware of your own resources. 4. "Cage of emotions". Release. 5. Conclusion. Reflection and transfer to everyday life. Farewell. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Movement Therapy (DMT)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. | Behavioural | DMT arm |
Primary outcome
Primary objective
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
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".
7 secondary outcomes
Assessment of muscle strength using the Jamar hand dynamometer
Time frame: weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)
Assessment of Body Mass Index
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)
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)
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
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
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
Time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Movement Therapy (DMT) in people with Cancer Patients and Physical Activity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: in the week 1 (baseline) in the week 3, in the week 5 (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.