Advanced CancerPhase 2NCT02930876
Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients
A Phase 2 study testing Resistance training in people with Advanced Cancer, run by King's College London at 1 site in United Kingdom.
Trial summary
Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion. Pharmacological treatments provide improvements in expected survival and symptoms, but at cost of a high rate of toxicities and increased time spent by patients away from their homes and families during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 8 Feb 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological diagnosis of cancer, incurable (stage IIIB/IV according to AJCC 2010).
Who cannot join
- chemotherapy within 90 days prior to study enrollment
- not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)
- bone metastasis in risk of fracture
- inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)
- considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if >50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients: a Phase II Trial
Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion. Pharmacological treatments provide improvements in expected survival and symptoms, but at cost of a high rate of toxicities and increased time spent by patients away from their homes and families during treatment. This is particularly important for patients with advanced disease as the timeframe at stake relates to their last months of life.
Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been widely reported as an important prognostic factor in advanced cancer, with impact on survival, toxicities, response to treatment and other patient-centered outcomes (such as functional capacity, quality of life and fatigue).
Read more
Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss. In 2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased functional performance and muscle strength. It has been reported as a hallmark of cancer, with impact on prognosis, response to treatments, side effects of chemotherapy and recovery after surgery. The prevalence of sarcopenia in advanced cancer seems to vary according to gender, stage, primary tumor location and treatments, being present in about 28 to 67% of patients.
Exercise, in particular resistance training, is one of the most powerful ways of increasing muscle mass and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia. There is evidence that resistance training can be effective but evidence is still scarce for patients with advanced disease. Historically there have been some concerns regarding safety and efficacy for oncologic patients, and though evidence suggests that resistance training is one of the most preferred forms of exercise by patients, the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer remains unknown. Another question is whether home (which seems to be the patients' preferred location for exercise) produces better results than hospital (the traditional location).
Read the detailed description
Study hypothesis: Home is the preferred setting for resistance training programs in adults newly diagnosed with advanced cancer, compared to hospital or standard care alone.
AIM: to test the feasibility and clinical impact of home vs. hospital based resistance training programs in adults newly diagnosed with advanced cancer, compared to standard care.
Objective 1: to describe the feasibility (defined as acceptability, compliance, recruitment and retention) of the two intervention models and control; Secondary outcome measures: Objective 2: to test their tolerability (patients' perception) and safety (number of adverse events due to the exercise); Objective 3: to explore the effect of the interventions on clinical outcomes (muscle mass, treatment related toxicities, strength, functional capacity, quality of life, fatigue); Objective 4: to evaluate the associated health resources use (unplanned medical appointments, acute and emergency visits and hospital admissions) in the intervention and control arms.
Study design: the investigators designed a three arm, randomised, open label, phase II trial, in advanced cancer patients, comparing 1) standard treatment concomitant with a resistance training program at home; 2) standard treatment concomitant with a resistance training program at the hospital; 3) standard treatment alone.
Overall trial start date: 01/05/2016 Overall trial end date: 31/03/2017 Condition: Advanced cancer Interventions: Resistance training at home, resistance training at the hospital
- Conditions
- Advanced Cancer
- Being tested
- Resistance training
- Keywords
- sarcopenia, cancer, chemotherapy, palliative care, resistance training
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Set of muscle strengthening exercises of all major muscle groups, guided by physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training at home | Experimental | Participants will undergo training sessions at their own homes. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes. Receives: Behavioral: Resistance training |
| Resistance training at the hospital | Experimental | Participants will undergo training sessions at the hospital. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes. Receives: Behavioral: Resistance training |
| Controls | No intervention | Participants will be given an information leaflet with the exercise recommendations of the Portuguese national ministry of health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of training sessions completed
Feasibility of the two intervention models assessed by the number of sessions completed
Measured: 3 months after baseline (at the end of the training program)
Number of exercises done within each session
Feasibility of the two intervention models assessed by the number of exercises completed in each session
Measured: 3 months after baseline (at the end of the training program)
Secondary outcomes (9)
Tolerability
Tolerability defined as the patients' perception of whether the program is tolerable on a Likert scale at 3 months after enrollment
Measured: 3 months after baseline (at the end of the training program)
Safety of the exercise program
Evaluated as the number of adverse events due to the exercise program
Measured: 3 months after baseline (at the end of the training program)
Change in muscle mass after the 3 months of exercise
to explore the effect of the interventions on muscle mass measured by DXA
Measured: Reported at baseline and 3 months after enrolment;
Frequency of treatment related toxicities
to explore the effect of the interventions on treatment related toxicities reported according to Common Toxicity Criteria for Adverse Events
Measured: Reported at baseline and 3 months after enrolment;
Change in strength after the 3 months of exercise
to explore the effect of the interventions on strength assessed through sit to stand transitions
Measured: Reported at baseline and 3 months after enrolment;
Change in functional capacity after the 3 months of exercise vs controls
to explore the effect of the interventions on functional capacity assessed though 6 minute walking test
Measured: Reported at baseline and 3 months after enrolment;
Change in quality of life after the 3 months of exercise vs controls
to explore the effect of the interventions on quality of life assessed using EORTC QoL C30
Measured: Reported at baseline and 3 months after enrolment;
Change in fatigue after the 3 months of fatigue vs controls
to explore the effect of the interventions on fatigue assessed using Brief Fatigue Inventory
Measured: Reported at baseline and 3 months after enrolment;
Health resources use
number of unplanned medical appointments, acute and emergency visits and hospital admissions
Measured: 3 months after baseline (at the end of the training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Calouste Gulbenkian Foundation, Centro Hospitalar de Lisboa Central
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930876
- Sponsor's protocol ID
- HR-15/16-2960
- Status last verified
- Aug 2016
- First submitted
- 2 Sep 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Presentation in conferences and publication in peer reviewed journals
Publications
Ribeiro C, Santos R, Correia P, Maddocks M, Gomes B. Resistance training in advanced cancer: a phase II safety and feasibility trial-home versus hospital. BMJ Support Palliat Care. 2022 Sep;12(3):287-291. doi: 10.1136/bmjspcare-2020-002230. Epub 2020 Aug 13.
PubMed 32792420
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home vs. Hospital Based Resistance Training for Advanced Cancer Patients: a Phase II Trial
- ClinicalTrials.gov ID
- NCT02930876
- Acronym / sponsor ID
- HR-15/16-2960
- Conditions
- Advanced Cancer
- Keywords
- sarcopenia, cancer, chemotherapy, palliative care, resistance training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Calouste Gulbenkian Foundation, Centro Hospitalar de Lisboa Central
- Study start
- Jul 2016
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 12 Oct 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.
Cancer causes 8.2 million deaths each year, with an estimated worldwide cost of $895 billion. Pharmacological treatments provide improvements in expected survival and symptoms, but at cost of a high rate of toxicities and increased time spent by patients away from their homes and families during treatment. This is particularly important for patients with advanced disease as the timeframe at stake relates to their last months of life.
Sarcopenia (i.e. loss of muscle mass together with decreased functional capacity) has been widely reported as an important prognostic factor in advanced cancer, with impact on survival, toxicities, response to treatment and other patient-centered outcomes (such as functional capacity, quality of life and fatigue).
Sarcopenia is a term first used in 1988 by Rosenberg, meaning an age-related loss in skeletal muscle mass and function. It was derived from the greek: sarx = flesh and penia = loss. In 2010, a European Consensus defined sarcopenia as a triad of muscle mass loss, decreased functional performance and muscle strength. It has been reported as a hallmark of cancer, with impact on prognosis, response to treatments, side effects of chemotherapy and recovery after surgery. The prevalence of sarcopenia in advanced cancer seems to vary according to gender, stage, primary tumor location and treatments, being present in about 28 to 67% of patients.
Exercise, in particular resistance training, is one of the most powerful ways of increasing muscle mass and evidence from elderly patients suggests that it is among the most promising interventions for sarcopenia. There is evidence that resistance training can be effective but evidence is still scarce for patients with advanced disease. Historically there have been some concerns regarding safety and efficacy for oncologic patients, and though evidence suggests that resistance training is one of the most preferred forms of exercise by patients, the effectiveness of resistance training alone on sarcopenia in patients with advanced cancer remains unknown. Another question is whether home (which seems to be the patients' preferred location for exercise) produces better results than hospital (the traditional location).
Detailed description
Study hypothesis: Home is the preferred setting for resistance training programs in adults newly diagnosed with advanced cancer, compared to hospital or standard care alone.
AIM: to test the feasibility and clinical impact of home vs. hospital based resistance training programs in adults newly diagnosed with advanced cancer, compared to standard care.
Objective 1: to describe the feasibility (defined as acceptability, compliance, recruitment and retention) of the two intervention models and control; Secondary outcome measures: Objective 2: to test their tolerability (patients' perception) and safety (number of adverse events due to the exercise); Objective 3: to explore the effect of the interventions on clinical outcomes (muscle mass, treatment related toxicities, strength, functional capacity, quality of life, fatigue); Objective 4: to evaluate the associated health resources use (unplanned medical appointments, acute and emergency visits and hospital admissions) in the intervention and control arms.
Study design: the investigators designed a three arm, randomised, open label, phase II trial, in advanced cancer patients, comparing 1) standard treatment concomitant with a resistance training program at home; 2) standard treatment concomitant with a resistance training program at the hospital; 3) standard treatment alone.
Overall trial start date: 01/05/2016 Overall trial end date: 31/03/2017 Condition: Advanced cancer Interventions: Resistance training at home, resistance training at the hospital
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training at home | Experimental | Behavioral: Resistance trainingParticipants will undergo training sessions at their own homes. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes. |
| Resistance training at the hospital | Experimental | Behavioral: Resistance trainingParticipants will undergo training sessions at the hospital. The exercise program will be individualized and guided by trained physiotherapists, for 3 months completion, aiming at 2-3 sessions a week (27 to 40 sessions in total), each lasting 45-60 minutes. |
| Controls | No intervention | –Participants will be given an information leaflet with the exercise recommendations of the Portuguese national ministry of health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histological diagnosis of cancer, incurable (stage IIIB/IV according to AJCC 2010).
Key exclusion criteria (5 listed)
- chemotherapy within 90 days prior to study enrollment
- not having a baseline (pre-treatment) Computed Tomography of the Thorax Abdomen and Pelvis (CTTAP) and whole body dual x-ray absorptometry (DXA) (this is important because having an assessment of baseline muscle mass will allow us to control for baseline sarcopenia and calculate changes from baseline to post-intervention)
- bone metastasis in risk of fracture
- inability to comply with the intervention for any known reasons (including physical or mental impairment that limits the capacity to undertake the exercise program)
- considered to be at cardiovascular risk (defined by a pre-exercise cardiologic evaluation with electrocardiogram (ECG) and echocardiogram when indicated (echocardiogram if >50 years old, NYHA class I, angor, cardiovascular risk factors and abnormal ECG)).
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 |
|---|---|---|
| Resistance trainingSet of muscle strengthening exercises of all major muscle groups, guided by physiotherapists. | Behavioural | Resistance training at home, Resistance training at the hospital |
Primary outcome
Number of training sessions completed
Time frame: 3 months after baseline (at the end of the training program)
Feasibility of the two intervention models assessed by the number of sessions completed
Number of exercises done within each session
Time frame: 3 months after baseline (at the end of the training program)
Feasibility of the two intervention models assessed by the number of exercises completed in each session
9 secondary outcomes
Tolerability
Time frame: 3 months after baseline (at the end of the training program)
Safety of the exercise program
Time frame: 3 months after baseline (at the end of the training program)
Change in muscle mass after the 3 months of exercise
Time frame: Reported at baseline and 3 months after enrolment;
Frequency of treatment related toxicities
Time frame: Reported at baseline and 3 months after enrolment;
Change in strength after the 3 months of exercise
Time frame: Reported at baseline and 3 months after enrolment;
Change in functional capacity after the 3 months of exercise vs controls
Time frame: Reported at baseline and 3 months after enrolment;
Change in quality of life after the 3 months of exercise vs controls
Time frame: Reported at baseline and 3 months after enrolment;
Change in fatigue after the 3 months of fatigue vs controls
Time frame: Reported at baseline and 3 months after enrolment;
Health resources use
Time frame: 3 months after baseline (at the end of the training program)
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 7 Mar 2017.
- Derived from this study: PubMed 32792420Ribeiro C, Santos R, Correia P, Maddocks M, Gomes B. Resistance training in advanced cancer: a phase II safety and feasibility trial-home versus hospital. BMJ Support Palliat Care. 2022 Sep;12(3):287-291. doi: 10.1136/bmjspcare-2020-002230. Epub 2020 Aug 13.
- Individual participant dataSharing planned: Yes. Presentation in conferences and publication in peer reviewed journals
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resistance training in people with Advanced Cancer, run by King's College London at 1 site in United Kingdom.
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 1 inclusion and 5 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 7 Mar 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of training sessions completed (time frame: 3 months after baseline (at the end of the training program)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930876, which also lists 1 linked publication.
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 7 Mar 2017.