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Optimal Timing of Physical Activity in Cancer Treatment (ACT)

This study is currently recruiting participants.
Verified November 2017 by A.M.E. Walenkamp, University Medical Center Groningen
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642680
First Posted: July 17, 2012
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen
  Purpose
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).

Condition Intervention
Metabolic Syndrome Vascular Disorders Cardiovascular Risk Factors Fatigue Other: A tailored physical activity program during chemotherapy Other: A tailored physical activity program after chemotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity

Resource links provided by NLM:


Further study details as provided by A.M.E. Walenkamp, University Medical Center Groningen:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 206
Study Start Date: January 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with testicular, early colon or breast cancer 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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Annemiek Walenkamp, MD, PhD +31 (0)50 3612824 a.walenkamp@umcg.nl
Contact: Jourik Gietema, MD, PhD +31 (0)50 3611334 j.a.gietema@umcg.nl

Locations
Netherlands
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         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Annemiek Walenkamp, PhD University Medical Center Groningen
  More Information

Responsible Party: A.M.E. Walenkamp, Prinicipal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01642680     History of Changes
Other Study ID Numbers: 2012-0010
41087 ( Registry Identifier: ABR )
First Submitted: July 4, 2012
First Posted: July 17, 2012
Last Update Posted: November 10, 2017
Last Verified: November 2017

Keywords provided by A.M.E. Walenkamp, University Medical Center Groningen:
Physical activity program
Chemotherapy
Metabolic syndrome
Reducing cardiovascular risk factors
low physical activity level

Additional relevant MeSH terms:
Metabolic Syndrome X
Fatigue
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Cardiovascular Diseases