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PACES: Physical exercise during Adjuvant Chemotherapy Effectiveness Study.

Effectiveness of physical exercise during chemotherapy to improve physical fitness and reduce fatigue: A randomized trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20755
Enrollment
360
Registered
2010-01-11
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

breast cancer, colon cancer, borstkanker, darmkanker

Interventions

1. Onco-Move
2. OnTrack. 1. Onco-Move is a relatively low intensity, home-based, individualized, self-managed physical activity program based on the “Every Step Counts” program of Mock. It uses self-management pr

Sponsors

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histologically confirmed primary breast or primary colon cancer who are scheduled to undergo adjuvant chemotherapy with curative intent.

Exclusion criteria

Exclusion criteria: Patients with comorbid conditions that would contraindicate participation in a physical activity/exercise program. This includes patients with serious orthopedic conditions that would hamper functional recovery, and patients with serious cardiovascular or cardiopulmonary conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients suffering from malnutrition as evidenced by a BMI < 18 kg/m2, unintended weight loss of more than 5% per month, or more than 10% unintended weight loss during the previous 6 month period will be considered poor candidates for physical condition training and thus will not be eligible for participation. Patients judged to have serious psychiatric or cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language. Patients participating in concurrent studies or rehabilitation programs containing elements of physical activity or exercise will also be considered ineligible for the study.

Design outcomes

Primary

MeasureTime frame
1. Cardiorespiratory fitness; 2. Muscle strength; 3. Self-reported fatigue.

Secondary

MeasureTime frame
1. Mood disturbance; 2. Self-reported physical activity level; 3. Functioning in daily life; 4. Health-related quality of life; 5. Quality of sleep; 6. Measured physical activity level; 7. Chemotherapy completion rates; 8. Complaince; 9. Statisfaction with intervention;

Contacts

Public ContactH. Waart, van

Plesmanlaan 121

h.v.waart@nki.nl+31 (0)20 5122474

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)