all carcinoma (except for lung carcinoma) C00-C97
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men with carcinoma undergoing chemotherapy as an adjuvant or primary therapy Patients treated with conventional chemotherapy: - Alkylating agents - Antimetabolites - Anthracyclines - Taxanes - Vincaalcaloides - Patients treated with antibody therapy
Exclusion criteria
Exclusion criteria: - Patients with lung-ca - Relapsed carcinoma - Recent serious cardiovascular events (including but not limited to poorly controlled hypertension and congestive heart failure) - Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient - Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol - Known spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed - Peripheral neuropathy - Men participating in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week - shortness of breath, chest discomfort, or palpitations when performing activities of daily living - Men having difficulties of climbing a flight of stairs due to physical impairment - Ongoing restriction of physical activity with physician documentation - chest pain brought on by physical activity and chest pain developed in the past month - Patients with carcinoma which limit physical exercise on a bike ergometer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and compliance assessed by the following questionnaires (at baseline and after 4 weeks of training): BPI-SF (Brief Pain Inventory - Short Form) FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) FACIT-TS-G (Functional Assessment of Chronic Illness Therapy - Treatment rating) PSQI (Pittsburgh Sleep Quality Index) Immune status assessed by venous blood analyses (at baseline and after 4 weeks of training). | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function assessed by questionnaire FACT-Cog (Functional Assessment of Cancer Therapy - Cognitive Function) (Baseline and after 4 weeks of training) Quality of life assessed by questionnaire EORTC-QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) (Baseline und nach 4 Wochen Training) Health perception assessed by questionnaire EQ-5D (EuroQol five dimensions questionnaire) (Baseline and after 4 weeks of training) Aerobic capacity assessed by incremental cycle ergometer test (Baseline and after 4 weeks of training) Maximal strength of leg exensors assessed by a dynamic one repetition maximum test (Baseline and after 4 weeks of training) Physiological and psychological stress assessed by heart rate variability (3 x wöchentlich) Arterial stiffnes assessed by pulse wave analysis (Baseline and after 4 weeks of training) Additional biochemical analyses by venous blood samples (Baseline and after 4 weeks of training) Acute loading measurements: In addition, acute responses to a single training session will also be assessed throughout and after the first (week 1) and last (week 4) training session. These include: Assessment of Blood lactate concentrations Assessment of Fatigue (FACIT-F) Assessment of Rate of perceived Exertion (RPE Scale) Assessment of heart rate Assessment of heart rate variability Oxygen saturation | — |
Countries
Germany
Contacts
Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. 2: Molekulare und Zelluläre Sportmedizin