Optimal Timing of Physical Activity in Cancer Treatment
Condition: Metabolic Syndrome; Vascular Disorders; Cardiovascular Risk Factors; Fatigue
MeSH terms: Vascular Diseases; Metabolic Syndrome
Study type: Interventional

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.
    

Intervention name(s): A tailored physical activity program during chemotherapy; A tailored physical activity program after chemotherapy
Intervention type(s): Other; Other
Intervention description(s): The early group will start the PA program during chemotherapy for 3 months, and after completion of chemotherapy for 3 months (total 6 months). The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.; The late group will start the PA program after completion of the chemotherapy for 6 months. The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Physical activity program; Chemotherapy; Metabolic syndrome; Reducing cardiovascular risk factors; low physical activity level