Advanced Gastrointestinal CancerNCT02677129
Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
A study testing home-based exercise intervention in people with Advanced Gastrointestinal Cancer, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Advanced Gastrointestinal Cancer
- What is being tested?
- home-based exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically classified gastrointestinal cancer
- UICC III-IV
- Prior to (planned) first-line chemotherapy (curative und palliative)
- ≥50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Advanced Gastrointestinal Cancer
- Being tested
- home-based exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based exercise interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| home-based exercise intervention | Experimental | home-based exercise intervention:
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. Receives: Other: home-based exercise intervention |
| Waiting control group | No intervention | The wait list control group receives usual care over the study period. Usual care depends on the hospital guidelines as well as oncologists' and physicians' consideration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.
Measured: Change between the first 12 weeks of chemotherapy
Secondary outcomes (16)
Daily physical activity
7 days accelerometry
Measured: 3 times in the course of 12 weeks of chemotherapy
Polyneuropathy
Measuring the sensibility with a Rydel-Seiffer tuning fork
Measured: 3 times in the course of 12 weeks of chemotherapy
Gait speed
usual gait speed (km/h) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)
Measured: 3 times in the course of 12 weeks of chemotherapy
Postural sway
balance measuring (COP) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)
Measured: 3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the upper extremity
JAMAR Hand Dynamometer
Measured: 3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the lower extremity
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°).
Measured: 3 times in the course of 12 weeks of chemotherapy
Muscular endurance (Chair-Rise Test)
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.
Measured: 3 times in the course of 12 weeks of chemotherapy
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30)
Measured: 3 times in the course of 12 weeks of chemotherapy
Quality of life
The 36-Items Short Form Health Survey (SF-36)
Measured: 3 times in the course of 12 weeks of chemotherapy
Nutrition Assessment
Mini Nutritional Assessment (MNA)
Measured: 3 times in the course of 12 weeks of chemotherapy
Phase angle
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle
Measured: 3 times in the course of 12 weeks of chemotherapy
Body cell mass
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM)
Measured: 3 times in the course of 12 weeks of chemotherapy
Fat mass
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass
Measured: 3 times in the course of 12 weeks of chemotherapy
Perceived functional ability
perceived functional ability scale
Measured: 3 times in the course of 12 weeks of chemotherapy
Activities of daily living
Functional Independence Measurement (FIM) Questionnaire
Measured: Change between the first 12 weeks of chemotherapy
Activities of daily living
- instrumental Activity of Daily Living (iADL)
Measured: Change between the first 12 weeks of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Agaplesion Markus Krankenhaus gGmbH
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
- Investigators
- Winfried Banzer, Prof., Principal investigator, Department of Sports Medicine, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677129
- Sponsor's protocol ID
- SPM2015-003
- Status last verified
- Apr 2017
- First submitted
- 2 Feb 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Only pseudonymised data without the plan to share
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
- ClinicalTrials.gov ID
- NCT02677129
- Acronym / sponsor ID
- SPM2015-003
- Conditions
- Advanced Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Agaplesion Markus Krankenhaus gGmbH
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home-based exercise intervention | Experimental | Other: home-based exercise interventionhome-based exercise intervention: 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. |
| Waiting control group | No intervention | –The wait list control group receives usual care over the study period. Usual care depends on the hospital guidelines as well as oncologists' and physicians' consideration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically classified gastrointestinal cancer
- UICC III-IV
- Prior to (planned) first-line chemotherapy (curative und palliative)
- ≥50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based exercise interventionEndurance 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. | Other | home-based exercise intervention |
Primary outcome
Short Physical Performance Battery
Time frame: 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.
16 secondary outcomes
Daily physical activity
Time frame: 3 times in the course of 12 weeks of chemotherapy
Polyneuropathy
Time frame: 3 times in the course of 12 weeks of chemotherapy
Gait speed
Time frame: 3 times in the course of 12 weeks of chemotherapy
Postural sway
Time frame: 3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the upper extremity
Time frame: 3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the lower extremity
Time frame: 3 times in the course of 12 weeks of chemotherapy
Muscular endurance (Chair-Rise Test)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Quality of life
Time frame: 3 times in the course of 12 weeks of chemotherapy
Quality of life
Time frame: 3 times in the course of 12 weeks of chemotherapy
Nutrition Assessment
Time frame: 3 times in the course of 12 weeks of chemotherapy
Phase angle
Time frame: 3 times in the course of 12 weeks of chemotherapy
Body cell mass
Time frame: 3 times in the course of 12 weeks of chemotherapy
Fat mass
Time frame: 3 times in the course of 12 weeks of chemotherapy
Perceived functional ability
Time frame: 3 times in the course of 12 weeks of chemotherapy
Activities of daily living
Time frame: Change between the first 12 weeks of chemotherapy
Activities of daily living
Time frame: Change between the first 12 weeks of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No. Only pseudonymised data without the plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Banzer, Prof. principal investigator
Department of Sports Medicine, Goethe University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based exercise intervention in people with Advanced Gastrointestinal Cancer, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Change between the first 12 weeks of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.