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Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity


N/A
18 Years
80 Years
Open (Enrolling)
Both
Metabolic Syndrome, Vascular Disorders, Cardiovascular Risk Factors, Fatigue

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Trial Information

Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Difference in VO2 max between the groups after completion of the PA program.

Outcome Description:

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).

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Annemiek Walenkamp, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

2012-0010

NCT ID:

NCT01642680

Start Date:

January 2013

Completion Date:

September 2016

Related Keywords:

  • Metabolic Syndrome
  • Vascular Disorders
  • Cardiovascular Risk Factors
  • Fatigue
  • Physical activity program
  • Chemotherapy
  • Metabolic syndrome
  • Reducing cardiovascular risk factors
  • low physical activity level
  • Fatigue
  • Vascular Diseases
  • Metabolic Syndrome X

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