Optimal Timing of Physical Activity in Cancer Treatment

NCT01642680 | Completed

• 2 other identifiers: 2012-001041087
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Syndrome; Vascular Disorders; Cardiovascular Risk Factors; Fatigue

Keywords

Physical activity program; Chemotherapy; Metabolic syndrome; Reducing cardiovascular risk factors; low physical activity level

Outcome Measures

Primary Outcomes (1)

• Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET).

  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

  1,5 year

Secondary Outcomes (26)

• Muscle strength using a hand-held dynamometer

  1,5 year

• Intima media thickness will be measured with vascular ultrasound

  1,5 year

• Cholesterol levels, measured in blood

  1,5 year

• Triglyceride levels, measured in blood

  1,5 year

• Glucose levels, measured in blood

  1,5 year

Study Arms (2)

Physical activity during chemotherapy

EXPERIMENTAL

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.

Other: A tailored physical activity program during chemotherapy

Physical activity after chemotherapy

ACTIVE COMPARATOR

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.

Other: A tailored physical activity program after chemotherapy

Interventions

A tailored physical activity program during chemotherapy 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 during chemotherapy

A tailored physical activity program after chemotherapy 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.

Physical activity after chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37889308 DERIVED

• 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.

  PMID: 36444224 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Vascular Diseases; Fatigue

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annemiek Walenkamp, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 17, 2012
• Study Start: January 24, 2013
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)