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How may exercise reduce fatigue in patients with cancer. A pilot study examining the role of muscular, immune and endocrine systems.

How may exercise reduce fatigue in patients with cancer. A pilot study examining the role of muscular, immune and endocrine systems. - MEchanisms of TRaining In patients with Cancer (METRIC)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43997
Enrollment
30
Registered
2013-03-18
Start date
2014-09-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer colorectal cancer

Interventions

Resistance and endurance exercise: the CytoFys program. Patients will participate in a 9 or 12-week resistance and endurance exercise intervention during chemotherapy. They will be randomly assigned

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with histological confirmed primary colorectal cancer or breast cancer stage II/III aged * 18 years, who will be treated with (neo-)adjuvant or first line chemotherapy.

Exclusion criteria

Exclusion criteria: Patients who are not able to perform basic activities such as walking or biking, who show cognitive disorders or severe emotional instability, who are suffering from other disabling co-morbidity that might hamper physical exercise (e.g. heart failure, chronic obstructive pulmonary disease (COPD), orthopaedic conditions and neurological disorders), and patients who are unable to understand and read the Dutch language will be excluded from the study

Design outcomes

Primary

MeasureTime frame
The main outcome of measures of this pilot study are: a) Measurements of muscles contractile properties, i.e. muscle force, speed of force development and relaxation, and fatigability. b) Measures of inflammation (CRP, IL-6, TNF-alpha) c) Measures of the insulin pathway (insulin, IGF, C-peptide).

Secondary

MeasureTime frame
Secondary outcome measures are perceived fatigue, assessed with the Multidimensional Fatigue Inventory (MFI) (60), and health-related quality of life, assessed with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QL-C30). Sociodemographic factors (e.g. age, gender) will be assessed with questionnaires. Physical activity will also be measured by questionnaire. Cardiorespiratory fitness will be measured using a submaximal exercise test (Chester step test). Upper and lower extremity strength will be measured using a handgrip dynamometer and 30s sit to stand test. Body composition will be assessed by measuring height, weight, hip and waist circumference, and thickness of four skinfolds. These assessments correspond to those used in the Alpe d*HuZes Cancer Rehabilitation (A-CaRe) research programme . Information on clinical variables (e.g. diagnose, tumour stage, treatment and follow-up data including progression free survival (PFS) and overall survival (OS) up to 5 years after diagnosis) will be obtained by medical records.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)