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Optimal Timing of Physical Activity in Cancer Treatment (ACT)

This study is currently recruiting participants.
Verified February 2013 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01642680
First received: July 4, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Difference in VO2 max between the groups after completion of the PA program. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • change in metabolic and cardiovascular damage parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • cardiovascular risk factors and quality of life including self-efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • fatigue and physical activity level [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Centre Groningen
Investigators
Principal Investigator: Annemiek Walenkamp, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: A.M.E. Walenkamp, Prinicipal investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01642680     History of Changes
Other Study ID Numbers: 2012-0010, 41087
Study First Received: July 4, 2012
Last Updated: February 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
Physical activity program
Chemotherapy
Metabolic syndrome
Reducing cardiovascular risk factors
low physical activity level

Additional relevant MeSH terms:
Fatigue
Vascular Diseases
Metabolic Syndrome X
Signs and Symptoms
Cardiovascular Diseases
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013