Optimal Timing of Physical Activity in Cancer Treatment

NCT ID: NCT01642680

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-24
• Study Completion Date: 2020-10-22

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.

Conditions

Metabolic Syndrome; Vascular Disorders; Cardiovascular Risk Factors; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physical activity during chemotherapy

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.

Group Type: EXPERIMENTAL

A tailored physical activity program during chemotherapy

Intervention Type: OTHER

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.

Physical activity after chemotherapy

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.

Group Type: ACTIVE_COMPARATOR

A tailored physical activity program after chemotherapy

Intervention Type: OTHER

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.

Interventions

A tailored physical activity program during chemotherapy

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.

Intervention Type: OTHER

A tailored physical activity program after chemotherapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemiek Walenkamp, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, , Netherlands

Countries

Netherlands

References

van der Schoot GGF, Ormel HL, Westerink NL, Wempe JB, Lefrandt JD, May AM, Vrieling AH, Meijer C, Gietema JA, Walenkamp AME. Physical exercise in patients with testicular cancer treated with bleomycin, etoposide and cisplatin chemotherapy: pulmonary and vascular endothelial function-an exploratory analysis. J Cancer Res Clin Oncol. 2023 Dec;149(19):17467-17478. doi: 10.1007/s00432-023-05469-5. Epub 2023 Oct 27.

Reference Type: DERIVED

PMID: 37889308 (View on PubMed)

van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.

Reference Type: DERIVED

PMID: 36444224 (View on PubMed)

Other Identifiers

41087

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0010

Identifier Type: -

Identifier Source: org_study_id