Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- University Medical Center Groningen
- Enrollment
- 266
- Locations
- 1
- Primary Endpoint
- Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET).
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The number of long-term cancer survivors is growing. As a result, treatment-related morbidity - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is impacting quality of life and impairing survival. Metabolic syndrome in the general population is currently treated with lifestyle advice to increase physical activity (PA) and reduce caloric intake. This approach is still underused as standard care for cancer survivors. The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy).
Detailed Description
Improved treatment is partly responsible for the increased survival and life expectancy in cancer patients. However, such treatment can be harmful as well, and cancer survivors therefore, face an increased risk of second malignancies and other chronic diseases, e.g. cardiovascular diseases and metabolic syndrome. Due to the growing number of cancer patients and survivors, attention for rehabilitation, especially physical training, is growing. Several meta-analyses show the beneficial effects of physical training on several outcomes such as physical fitness, muscle strength, fatigue and quality of life, and a few studies showed the effect of exercise on physical active behaviour. However, studies on the effect of timing of exercise are lacking. The present study aims to insert a tailored physical activity program early versus late in the chemotherapy based cancer treatment and will yield data about its safety and efficacy. We hypothesize that a tailored physical activity program during early cancer treatment may more be effective to reduce long-term cancer treatment toxicities and morbidity in cancer survivors compared to a program after cancer treatment. Primary Objective: To investigate whether a tailored physical activity program that starts during chemotherapy (early) is superior in terms of physical fitness, as determined by VO2 peak at one year, to a program that starts after completion of chemotherapy (late). Secondary Objectives: To examine the effect of the physical activity program on muscle strength and activity level, change in metabolic and cardiovascular damage parameters, cardiovascular risk factors and quality of life including self-efficacy, motivation for exercise, and fatigue. Design: This protocol describes a multicenter, randomized study with 2 arms. Patients who will be treated with curative systemic chemotherapeutic treatment for testicular cancer, early colon cancer, early breast cancer or B-NHL will be randomized into an early or late PA program group. The early group will start the PA program during chemotherapy (for 12 weeks) until 12 weeks after completion of chemotherapy (total 24 weeks of training). The late group will start the same program (total of 12 weeks) after completion of chemotherapy. The longitudinal effects of the physical activity (PA) program for all participants will be evaluated at different time points in the UMCG: before start of chemotherapeutic treatment; at the start of the PA program and at 3, 6, 18 months after starting the PA program and 18 months after the last chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with testicular, early colon, breast cancer or B-NHL with an indication for systemic chemotherapy with a curative intent
- •Normal blood count at start of systemic treatment
- •Patients need to have an adequate physical health, which is defined by diastolic blood pressure \>45 mm Hg or \<95 mm Hg; heart frequency in at rest \< 100 per minute; body temperature below 38°C; respiration frequency in rest below 20 per minute
- •Adequate cardiac function with a LVEF above the lower limit of normal
- •Written informed consent
Exclusion Criteria
- •Infections requiring actual antibiotics
- •Signs of ongoing bleeding or fresh petechiae; unexplained bruises
- •Critical organ impairment due to their malignancy
- •Not recovered from earlier surgical intervention
- •Non adequate control of any symptoms of the malignancy
- •Inability to travel independently to the rehabilitation centre
- •Cognitive disorder or emotional instability that might impede the participation in the training program
- •Recent cardiovascular event
Outcomes
Primary Outcomes
Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET).
Time Frame: 1,5 year
The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy). The VO2 at the peak of the exercise will be defined as peak oxygen uptake (VO2 peak), measured by cardiopulmonary exercise testing (CPET) on a stationary bicycle ergometer. The CPET is considered to be the most precise measure of cardio-respiratory fitness and is recommended for use in order to determine a patient's objective or subjective difference in exercise capacity
Secondary Outcomes
- Diffusion capacity of the lungs(1,5 year)
- Forced vital capacity (FVC) will be assessed by use of dynamic spirometry(1,5 year)
- Health related quality of life measured with the EORTC QLQ-C30(1,5 year)
- Forced expiratory volume in one second (FEV1) will be assessed by use of dynamic spirometry,(1,5 year)
- Factor VIII, measured in blood serum(1,5 year)
- Muscle strength using a hand-held dynamometer(1,5 year)
- Triglyceride levels, measured in blood(1,5 year)
- Body mass index, calculated with formula (see below)(1,5 year)
- Body composition will be assessed with a DEXA scan(1,5 year)
- PAI-antigen, measured in blood serum(1,5 year)
- t-PA, measured in blood serum(1,5 year)
- Intima media thickness will be measured with vascular ultrasound(1,5 year)
- Cholesterol levels, measured in blood(1,5 year)
- Glucose levels, measured in blood(1,5 year)
- Cardiac function with echocardiography (Ultrasound technique)(1,5 year)
- Von Willebrand factor, measured in blood serum(1,5 year)
- Fibrinogen, measured in blood serum(1,5 year)
- Patient reported self-efficacy measured using the ALCOS instrument(1 year)
- Patient reported physical activity level with the PASE questionnaire(1,5 year)
- DNA collection(1,5 year)
- FEV1/FVC ratio will be assessed by use of dynamic spirometry,(1,5 year)
- Senescence with markers of the senescence- associated secretory phenotype(1,5 year)
- Advanced glycation end products (AGEs) will be determined by measuring skin auto fluorescence.(1,5 year)
- Fat percentage with skinfold measurement(1.5 years)
- Patient reported fatigue measured with the Multi-dimensional Fatigue Inventory(1,5 year)
- Blood pressure, measured with a blood pressure cuff(1,5 years)