Non Small Cell Lung CancerEMBRACENCT03334071
Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients
A study testing Exercise in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Stage IIIB, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Trial Phase: Pilot Indication: Stage IIIB/IV NSCLC Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy. Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non Small Cell Lung Cancer Metastatic
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2014to 30 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged over 18 years old
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Stage IIIb/IV disease
- Patients being treated with first line gemcitabine and platinum based chemotherapy (other equivalent regimens may be considered on discussion with Judith Cave)
- Performance status 0-2 (PS 2 have to be deemed fit enough to complete all cycles of chemotherapy).
Who cannot join
- Unable to consent
- Under 18 years
- Unable to perform CPET
- Significant cardiac ischaemia of > 1.5mm symptomatic and > 2mm asymptomatic observed on the baseline ECG
- Weight of >145kg (weight limit for cycle ergometer)
- Any other contraindication to CPET based on ACCP/ATS Guidelines and summarised in the table below.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: Exercise regiMens Before and duRing Advanced Cancer thErapy: A Pilot Study to Investigate Improvements in Physical Fitness With Exercise Training Programme Before and During Chemotherapy in Advanced Lung Cancer Patients.
Trial Phase: Pilot
Indication: Stage IIIB/IV NSCLC
Read more
Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy.
Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness.
- To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline.
4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation.
- To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy.
- To document the effects of chemotherapy on cellular energetics and mitochondrial function.
Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training.
Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm.
Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).
Read the detailed description
EMBRACE is a multi-centre pilot study for 100 patients with EGFR negative NSCLC undergoing first line platinum based chemotherapy. It is a prospective randomised (1:1) 2-arm controlled study. A nested mechanism study will be performed in a sub group of patients willing to have muscle biopsies.
Patients will be randomised to the exercise intervention or the control arm. All patients will undergo standard chemotherapy with gemcitabine and carboplatin (or equivalent) for 12 weeks. Patients randomised to the intervention arm will undergo concurrent exercise training during their 12 weeks of chemotherapy treatment. Patients randomised to the control arm will undergo chemotherapy only. During the 12 weeks of the study, assessments will be performed on all patients (including CPET tests and HRQL questionnaires). The exercise training sessions and study assessments will not affect timing of delivery of chemotherapy. Patients who decline randomisation will be offered entry into an observational study.
The follow-up phase will commence when patients have completed 12 weeks of chemotherapy, or sooner for patients who stop chemotherapy early due to progressive disease or toxicity. During the follow-up phase data will be for survival and to follow any AEs related to study procedures. AEs not related to study procedures will not require follow up. Ongoing chemotherapy after week 12 will be as per investigator and patient choice, and may include further induction cycles, maintenance chemotherapy, or observation.
In a subgroup of willing patients muscle biopsies will be performed at baseline, during chemotherapy, and after completion of chemotherapy.
TRIAL OUTCOME MEASURES
The primary outcome variables for this feasibility and tolerability study will be adherence to the exercise training program, and adverse events.
The secondary outcome variables will be response to chemotherapy, fitness levels as measured by Cardiopulmonary Exercise Testing (CPET), Time to get up and go test (TUG), grip strength, bioimpedance, CT measures of cancer cachexia, and Montreal score, cancer related symptoms, HRQL, and activity levels.
The exploratory outcome variables will be overall survival, toxicity, and biomarkers of stress and cellular energetics.
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non Small Cell Lung Cancer Metastatic
- Being tested
- Exercise
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
High intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session.
The supervised in-hospital exercise training sessions will last <1 hour, exercise training intensities will be individually tailored to each CPET. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high intensity (50%Δ) for a predetermined amount of time.
The home-based training programme will involve stair climbing (where possible) and brisk walking to achieve heart rates commensurate with those achieved during the in-hospital exercise training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Active comparator | Patients in the intervention arm will participate in a supervised in-hospital, exercise training program on a cycle ergometer before and during chemotherapy. At week 5-6 there will be a transition period of in-hospital to home-based exercise training (at this point we will perform the exercises that they will perform at home in the in-hospital environment to ensure that the patient understands the home-based exercise training programme) and then week 7-12 will be home-based exercise training only with telephone support. Receives: Behavioral: Exercise |
| Negative Control | No intervention | Patients in the control arm will not undergo an exercise training program. |
| Observational | No intervention | Patients who do not enrol in RCT will be enrolled in the observational arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing exercise sessions as a function of the whole programme.
Adherence to the exercise training program
Measured: 12 weeks
Adverse events
Common Terminology on Complications (CTC AE v4)
Measured: 12 weeks
Secondary outcomes (12)
Fitness levels as measured by Cardiopulmonary exercise testing (CPET)
Physical fitness - oxygen uptake at anaerobic threshold
Measured: 12 weeks
Timed up and go test (TUG)
Physical fitness
Measured: 12 weeks
Grip strength
Physical fitness
Measured: 12 weeks
Montreal score - Prognostic survival score
Non small cell lung cancer stage, CRP, albumin, lactic acid dehydrogenase (LDH) and absolute neutrophil count/lymphocyte count ratio (N/L).
Measured: 12 weeks
Health related quality of life questionnaire
FACT-L quality of life questionnaire
Measured: 12 weeks
Health related quality of life questionnaire
Dukes Activity Status Index
Measured: 12 weeks
Health related quality of life questionnaire
International Physical Activity Questionnaire (IPAQ)
Measured: 12 weeks
Health related quality of life questionnaire
Godin Leisure Time Questionnaire (GLTEQ).
Measured: 12 weeks
Physical activity
Patients will wear a Sensewear Pro3 activity monitor (armband) or similar e.g. AX3 3-Axis Logging Accelerometer (wristband) for 72 hours. Number of steps in a 72 hours period will be calculated
Measured: 12 weeks
Survival
Overall survival
Measured: 1 year
Response to chemotherapy
Cross sectional imaging will be performed within 12 days of the third cycle of chemotherapy, to assess response to treatment. Scans will be reported according to the Response Evaluation Criteria for Solid Tumours (RECIST Version 1 http://www.irrecist.com/recist/recist-in-practice/01.html).
Measured: 12 weeks
Fitness levels as measured by Cardiopulmonary exercise testing (CPET)
Physical fitness - oxygen uptake at peak exercise
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start4 Apr 2014
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sandy Jack, PhD, Principal investigator, University Hospitals Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334071
- Sponsor's protocol ID
- RHM CAN 0960
- Other IDs
- 13/YH/0354
- Acronym
- EMBRACE
- Status last verified
- Jul 2019
- First submitted
- 26 Oct 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise regiMens Before and duRing Advanced Cancer thErapy: A Pilot Study to Investigate Improvements in Physical Fitness With Exercise Training Programme Before and During Chemotherapy in Advanced Lung Cancer Patients.
- ClinicalTrials.gov ID
- NCT03334071
- Acronym / sponsor ID
- EMBRACE / RHM CAN 0960
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Stage IIIB, Non Small Cell Lung Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Study start
- 4 Apr 2014 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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.
Trial Phase: Pilot
Indication: Stage IIIB/IV NSCLC
Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy.
Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness.
- To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline.
4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation.
- To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy.
- To document the effects of chemotherapy on cellular energetics and mitochondrial function.
Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training.
Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm.
Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).
Detailed description
EMBRACE is a multi-centre pilot study for 100 patients with EGFR negative NSCLC undergoing first line platinum based chemotherapy. It is a prospective randomised (1:1) 2-arm controlled study. A nested mechanism study will be performed in a sub group of patients willing to have muscle biopsies.
Patients will be randomised to the exercise intervention or the control arm. All patients will undergo standard chemotherapy with gemcitabine and carboplatin (or equivalent) for 12 weeks. Patients randomised to the intervention arm will undergo concurrent exercise training during their 12 weeks of chemotherapy treatment. Patients randomised to the control arm will undergo chemotherapy only. During the 12 weeks of the study, assessments will be performed on all patients (including CPET tests and HRQL questionnaires). The exercise training sessions and study assessments will not affect timing of delivery of chemotherapy. Patients who decline randomisation will be offered entry into an observational study.
The follow-up phase will commence when patients have completed 12 weeks of chemotherapy, or sooner for patients who stop chemotherapy early due to progressive disease or toxicity. During the follow-up phase data will be for survival and to follow any AEs related to study procedures. AEs not related to study procedures will not require follow up. Ongoing chemotherapy after week 12 will be as per investigator and patient choice, and may include further induction cycles, maintenance chemotherapy, or observation.
In a subgroup of willing patients muscle biopsies will be performed at baseline, during chemotherapy, and after completion of chemotherapy.
TRIAL OUTCOME MEASURES
The primary outcome variables for this feasibility and tolerability study will be adherence to the exercise training program, and adverse events.
The secondary outcome variables will be response to chemotherapy, fitness levels as measured by Cardiopulmonary Exercise Testing (CPET), Time to get up and go test (TUG), grip strength, bioimpedance, CT measures of cancer cachexia, and Montreal score, cancer related symptoms, HRQL, and activity levels.
The exploratory outcome variables will be overall survival, toxicity, and biomarkers of stress and cellular energetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Exercise intervention
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Active comparator | Behavioral: ExercisePatients in the intervention arm will participate in a supervised in-hospital, exercise training program on a cycle ergometer before and during chemotherapy. At week 5-6 there will be a transition period of in-hospital to home-based exercise training (at this point we will perform the exercises that they will perform at home in the in-hospital environment to ensure that the patient understands the home-based exercise training programme) and then week 7-12 will be home-based exercise training only with telephone support. |
| Negative Control | No intervention | –Patients in the control arm will not undergo an exercise training program. |
| Observational | No intervention | –Patients who do not enrol in RCT will be enrolled in the observational arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, aged over 18 years old
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Stage IIIb/IV disease
- Patients being treated with first line gemcitabine and platinum based chemotherapy (other equivalent regimens may be considered on discussion with Judith Cave)
- Performance status 0-2 (PS 2 have to be deemed fit enough to complete all cycles of chemotherapy).
Key exclusion criteria (6 listed)
- Unable to consent
- Under 18 years
- Unable to perform CPET
- Significant cardiac ischaemia of > 1.5mm symptomatic and > 2mm asymptomatic observed on the baseline ECG
- Weight of >145kg (weight limit for cycle ergometer)
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 |
|---|---|---|
| ExerciseHigh intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. The supervised in-hospital exercise training sessions will last <1 hour, exercise training intensities will be individually tailored to each CPET. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high intensity (50%Δ) for a predetermined amount of time. The home-based training programme will involve stair climbing (where possible) and brisk walking to achieve heart rates commensurate with those achieved during the in-hospital exercise training sessions. | Behavioural | Exercise Intervention |
Primary outcome
Number of participants completing exercise sessions as a function of the whole programme.
Time frame: 12 weeks
Adherence to the exercise training program
Adverse events
Time frame: 12 weeks
Common Terminology on Complications (CTC AE v4)
12 secondary outcomes
Fitness levels as measured by Cardiopulmonary exercise testing (CPET)
Time frame: 12 weeks
Timed up and go test (TUG)
Time frame: 12 weeks
Grip strength
Time frame: 12 weeks
Montreal score - Prognostic survival score
Time frame: 12 weeks
Health related quality of life questionnaire
Time frame: 12 weeks
Health related quality of life questionnaire
Time frame: 12 weeks
Health related quality of life questionnaire
Time frame: 12 weeks
Health related quality of life questionnaire
Time frame: 12 weeks
Physical activity
Time frame: 12 weeks
Survival
Time frame: 1 year
Response to chemotherapy
Time frame: 12 weeks
Fitness levels as measured by Cardiopulmonary exercise testing (CPET)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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.
Sandy Jack, PhD principal investigator
University Hospitals Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Stage IIIB, run by University Hospital Southampton NHS Foundation Trust 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 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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.
Are results available for this study?
Results are not available in the source record.
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 participants completing exercise sessions as a function of the whole programme. (time frame: 12 weeks). 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?
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 8 Jul 2019.