Advanced Gastrointestinal Cancer
Conditions
Brief summary
The study is a randomized controlled trial with the aim to examine the feasibility and the effects of a home-based exercise intervention program on activities of daily living (ADL) in patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further outcomes include functional and body status, quality of life, body composition, and chemotherapy completion rate. Study participants will be randomized to an exercise intervention group or a wait-list control group
Detailed description
A randomised longitudinal study. A total of 44 gastrointestinal cancer patients before their first-line chemotherapy are recruited and randomised into one of two treatment groups A: Home based- physical activity or B: wait-control. The intervention period is 12 weeks. Primary outcome are the ADLs (iADL 1-8; FIM 1-7).Secondary outcomes are the physical activity, quality of life, peripheral polyneuropathy, chemotherapy regimen, gait speed, postural stability, maximal isometric voluntary force of the upper extremity, Maximal isometric voluntary force (MIVF) and strength endurance of the lower extremity, nutritional state, body composition and perceive functional ability. All measurements are standardized and are performed before chemotherapy, after 2 cycles of chemotherapy (4-6weeks) and after 12 weeks.
Interventions
Endurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.
Sponsors
Agaplesion Markus Krankenhaus gGmbH
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically classified gastrointestinal cancer * UICC III-IV * Prior to (planned) first-line chemotherapy (curative und palliative) * ≥50 years
Exclusion criteria
* ECOG \> 2 * Systemic diseases (MS, ALS) * disorders (neurological, skeletal, muscular, mental or cognitive) or drug use (irrespective of the cancer therapy) that may affect gait, balance or muscular strength * chronic infection, uncontrolled hypertension (diastolic pressure over 95 mmHg) * vestibulopathies * uncorrected visual deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | Change between the first 12 weeks of chemotherapy | Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyneuropathy | 3 times in the course of 12 weeks of chemotherapy | Measuring the sensibility with a Rydel-Seiffer tuning fork |
| Gait speed | 3 times in the course of 12 weeks of chemotherapy | usual gait speed (km/h) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany) |
| Postural sway | 3 times in the course of 12 weeks of chemotherapy | balance measuring (COP) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany) |
| Maximum isometric voluntary force of the upper extremity | 3 times in the course of 12 weeks of chemotherapy | JAMAR Hand Dynamometer |
| Maximum isometric voluntary force of the lower extremity | 3 times in the course of 12 weeks of chemotherapy | The maximal isometric voluntary force (MIVF) of the randomly chosen knee extensor is measured with a strain gauge force transducer (ASYS®; SPOREG; 100 Hz) in a standardised seating position (predefined knee and hip angle = 90°). |
| Muscular endurance (Chair-Rise Test) | 3 times in the course of 12 weeks of chemotherapy | For the five times sit to stand test patients start in a standard position sitting on a chair that is placed next to the wall with the arms folded across their chest. They are asked to stand up from a chair to a full standing position and sit down again keeping the arms crossed for five times as quickly as possible. |
| Daily physical activity | 3 times in the course of 12 weeks of chemotherapy | 7 days accelerometry |
| Nutrition Assessment | 3 times in the course of 12 weeks of chemotherapy | Mini Nutritional Assessment (MNA) |
| Phase angle | 3 times in the course of 12 weeks of chemotherapy | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle |
| Body cell mass | 3 times in the course of 12 weeks of chemotherapy | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM) |
| Fat mass | 3 times in the course of 12 weeks of chemotherapy | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass |
| Perceived functional ability | 3 times in the course of 12 weeks of chemotherapy | perceived functional ability scale |
| Activities of daily living | Change between the first 12 weeks of chemotherapy | Functional Independence Measurement (FIM) Questionnaire |
| Quality of life | 3 times in the course of 12 weeks of chemotherapy | European Organisation for Research and Treatment of Cancer (EORTC\_QLQ-C30) |
Countries
Germany
Outcome results
None listed