Optimal Timing of Physical Activity in Cancer Treatment (ACT)

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Vascular Disorders; Cardiovascular Risk Factors; Fatigue; Metabolic Syndrome

Treatments: Other: A tailored physical activity program during chemotherapy; Other: A tailored physical activity program after chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01642680

2012-0010

41087 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

Physical activity during chemotherapy

Experimental group

Description:

This group will start with a physical activity program 3 months before the end of their chemotherapeutic regimen. After chemotherapy they will continue the PA program for another 3 months.

Treatment:

Other: A tailored physical activity program during chemotherapy

Physical activity after chemotherapy

Active Comparator group

Description:

This group will start with a physical activity program after the end of their chemotherapeutic regimen. The physical activity program wil take 6 months to complete.

Treatment:

Other: A tailored physical activity program after chemotherapy