Optimal Timing of Physical Activity in Cancer Treatment (ACT)
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|ClinicalTrials.gov Identifier: NCT01642680|
Recruitment Status : Recruiting
First Posted : July 17, 2012
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Vascular Disorders Cardiovascular Risk Factors Fatigue||Other: A tailored physical activity program during chemotherapy Other: A tailored physical activity program after chemotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: 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.
Other: 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.
Active Comparator: 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.
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.
- Difference in VO2 max between the groups after completion of the PA program. [ Time Frame: 1 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).
- Muscle strength [ Time Frame: 1 year ]
- change in metabolic and cardiovascular damage parameters [ Time Frame: 1 year ]
- cardiovascular risk factors and quality of life including self-efficacy [ Time Frame: 1 year ]
- fatigue and physical activity level [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642680
|Contact: Annemiek Walenkamp, MD, PhD||+31 (0)50 email@example.com|
|Contact: Jourik Gietema, MD, PhD||+31 (0)50 firstname.lastname@example.org|
|University Medical Centre Groningen||Recruiting|
|Groningen, Netherlands, 9713GZ|
|Principal Investigator: Annemiek ME Walenkamp, MD, PHD|
|Principal Investigator: Jourik A Gietema, MD, PhD|
|Principal Investigator: Ellen van Weert, PhD|
|Sub-Investigator: Nico-Derk L Westerink, MD|
|Principal Investigator:||Annemiek Walenkamp, PhD||University Medical Center Groningen|