Post-OP complications Health related quality of life, FatiqueAnxiety and depression,lymphedemapolyneuropathie
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • diagnosed breast cancer • at least 12 weeks prior to surgical therapy (breast-conserving therapy (BET) or radical mastectomy with axillary dissection) • neo-adjuvant chemotherapy or neo-adjuvant radio-chemotherapy • Written and valid declaration of consent from the patient • Age> = 18 years
Exclusion criteria
Exclusion criteria: • Neo-adjuvant radiotherapy alone • relapse • Second malignancies • WHO / ECOG performance status> 1 • Life expectancy <5 months • ductal carcinoma • metastases • All illness situations that do not allow hypertrophy training, in particular: o Clinically manifest heart failure (NYHA III-IV) o Partial or global respiratory failure o Permanent thrombocytopenia <10,000 / µl, e.g. refractory autoimmune thrombocytopenias. o Congenital or acquired thrombocytopathies or coagulation disorders. o Symptomatic CHD (exercise ECG recommended if necessary) o Severe refractory hypertension o Non-adjustable COPD o severe osteoporosis o acute migraines, epilepsy, dizziness • Taking antidepressants (SSRIs) and other drugs that affect quality of life • Medical or psychological condition (psychomotor deficits) that does not allow the patient to take part in the study • unwillingness to pass on personal illness data within the framework of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to test whether pre-rehabilitation hypertrophy training consisting of strength training for the upper extremities (m. Biceps brachii, m. Triceps brachii, m. Pectoralis) in combination with vibration training for hands and feet has a positive effect on the postoperative recovery process (End point: post-op complications). | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of quality of life (EORTC QLQ-C30, BR23) and fatigue syndrome (MFI 20) Reduction of pain, sleep disorders, anxiety, depression, nausea and vomiting (HADS Score) Reduction of postmenopausal symptoms Influence on lymphedema and shoulder-arm morbidity Improvement of the strength level (hand grip strength test, two-handed) Number of days in hospital Influence on chemotherapy-induced polyneuropathies PNP (FACT CogNXT) BIA Movement behavior (BSA) The assessments will take place on 4 occasions during the trial: T0 - 12 weeks pre-OP T1 - 1 weeks pre- OP T2 - 1 weeks post-OP t3 - 4 weeks Post-OP | — |
Countries
Germany
Contacts
Uniklinik Köln, Centrum für integrierte Onkologie (CIO);Sporthochschule Köln / Uniklinik Köln Centrum für integrierte Onkologie (CIO)