Vibration and balance training in breast cancer patients during radiotherapy - pilot study

Not Applicable

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00004862
• Lead Sponsor: Medizinische Universitätsklinik Freiburg Abtl. Hämatologie/Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-26
• Study Completion: 2013-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

breast cancer patients undergoing adjuvant radiotherapy (with or without lymphatic pathways)
- Age =18 years
- Performance- Status Karnofsky- Index >60
- Signed informed consent

Exclusion Criteria

Absolute:
- Instable bone metastases
- Myocardial infarction, Angina pectoris or heart disease (NYHA III-IV) in a time period of six months
- Arterial hypertension, which is not treated adequately (in therapy >180mmHg systolic; >100mmHg diastolic)
- Patients with an increased risk for thrombosis besides underlying disease

Relative (inclusion or continuation after recovery possible):
- Acute infection (=38,0°Celcius and/ or intravenously therapy with antibiotics)
- Thrombocytes < 10x10^9/L
- Leukocytes < 1x10^9/L
- Hb < 8g/dl

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
performed exercise sessions of IG compared to state of the art [%] (feasibilty of handheld vibration and balance training during radiotherapy)

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint will be assessed pre and post intervention (before radiation therapy and after 6 weeks with termination of radiation therapy) Lymphedema (volume in cm3), postural control (sway path of center of force (COF) in cm), mobility (sec in chair-rising-test), endurance capacity (watt at individual anaerobic threshold (IAT)), quality of life (EORCT-QLQ-C30), fatigue (MFI)