Locally Advanced Rectal CancerEarly Phase 1NCT01859442
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness
A Early Phase 1 study testing Structured responsive interval exercise training programme in people with Locally Advanced Rectal Cancer, run by Michelle Mossa at 1 site in United Kingdom.
Trial summary
The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery. Twelve patients will be randomised (1:1) to an intervention and a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Structured responsive interval exercise training programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Oct 2013
- Phase
- Early Phase 1
- 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
- diagnosis of T3N+ rectal cancer
- above age of 18
- able to conduct a cardiopulmonary exercise test on a cycle ergometer
Who cannot join
- unable to conduct a cardiopulmonary exercise test on a cycle ergometer
- metastatic disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aintree University Teaching Hospitals NHS FT
Liverpool, Merseyside, L97Al
About this study
Official title: Phase 1 Study of Mitochondrial Energetics After Long Course Chemoradiotherapy and a Short Term Exercise Programme in Locally Advanced Rectal Cancer Patients - A Randomized Controlled Trial.
The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.
Twelve patients will be randomised (1:1) to an intervention and a control group. The patients randomized to the intervention group will attend a total of 18 tailored exercise sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment. Where possible the exercise training sessions will be arranged to fit in with other appointments at the hospital. Patients randomized to the control group will be unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health related quality of life interviews at week 0, 3 and 6 during their exercise programme. These appointments will be directly before or after their exercise sessions to minimise hospital attendence.
Read more
Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this information can be accessed from patient notes and on the electronic patient records system.
This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.
HYPOTHESIS
- Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
- Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
- Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
- Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
- Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
- Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise training program?
- Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?
HYPOTHESIS for Mechanism Pilot Study
- To explore the exponential rate constant of post-exercise phosphocreatine recovery.
- To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.
Read the detailed description
All patients will attend 5 sets of appointments at the hospital for diagnostic tests and 3 appointments at the University of Liverpool Magnetic Resonance and Image Analysis Research Centre (MARIARC). Three appointments will be prior to chemoradiotherapy treatment, and the other 4 will be after chemoradiotherapy. Two of these 5 appointments are part of routine care. The first 4 appointments will last about an hour. Patients will complete 3 quality of life questionnaires on recruitment, during chemotherapy, before and 4-6 weeks after surgery. These 3 questionnaires will take 20 minutes to fill in. The fourth and fifth appointments will consist of Computed Tomogram (CT) and Magnetic Resonance Imaging (MRI) scans in our radiology department to assess cancer staging. These appointments will last about 1 hour 30 minutes.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Structured responsive interval exercise training programme, Sham group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured responsive interval exercise training programmeProcedure or surgery
Sham groupOther
NO intervention in this group, only standard care (no exercise programme)
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | 6 week structured responsive interval exercise training programme Receives: Procedure: Structured responsive interval exercise training programme |
| Control group | Sham comparator | Negative, unsupervised, out of hospital control group Receives: Other: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.
Measured: Between baseline and week 0 and between week 0 at week 6 post-NACRT
Secondary outcomes (1)
Alterations in mitochondrial energetics post-chemoradiotherapy and exercise
Changes in 31- Phosphoromagnetic resonance spectroscopic (31-PMRS) ATP:ADP ratio
Measured: Between baseline and week 0 and between week 0 and week 6 post-NACRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionOct 2013
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 Locally Advanced Rectal 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Mossa
- Sponsor type
- Other government
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor-investigator, Michelle Mossa, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859442
- Sponsor's protocol ID
- 11/H1002/12c
- Status last verified
- Sep 2013
- First submitted
- 13 May 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
West MA, Loughney L, Lythgoe D, Barben CP, Adams VL, Bimson WE, Grocott MP, Jack S, Kemp GJ. The effect of neoadjuvant chemoradiotherapy on whole-body physical fitness and skeletal muscle mitochondrial oxidative phosphorylation in vivo in locally advanced rectal cancer patients--an observational pilot study. PLoS One. 2014 Dec 5;9(12):e111526. doi: 10.1371/journal.pone.0111526. eCollection 2014.
PubMed 25478898
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Mitochondrial Energetics After Long Course Chemoradiotherapy and a Short Term Exercise Programme in Locally Advanced Rectal Cancer Patients - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01859442
- Acronym / sponsor ID
- 11/H1002/12c
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Michelle MossaOther government
- Collaborators
- University of Liverpool
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 May 2013 (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 present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.
Twelve patients will be randomised (1:1) to an intervention and a control group. The patients randomized to the intervention group will attend a total of 18 tailored exercise sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment. Where possible the exercise training sessions will be arranged to fit in with other appointments at the hospital. Patients randomized to the control group will be unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health related quality of life interviews at week 0, 3 and 6 during their exercise programme. These appointments will be directly before or after their exercise sessions to minimise hospital attendence.
Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this information can be accessed from patient notes and on the electronic patient records system.
This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.
HYPOTHESIS
- Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
- Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
- Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
- Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
- Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
- Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise training program?
- Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?
HYPOTHESIS for Mechanism Pilot Study
- To explore the exponential rate constant of post-exercise phosphocreatine recovery.
- To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.
Detailed description
All patients will attend 5 sets of appointments at the hospital for diagnostic tests and 3 appointments at the University of Liverpool Magnetic Resonance and Image Analysis Research Centre (MARIARC). Three appointments will be prior to chemoradiotherapy treatment, and the other 4 will be after chemoradiotherapy. Two of these 5 appointments are part of routine care. The first 4 appointments will last about an hour. Patients will complete 3 quality of life questionnaires on recruitment, during chemotherapy, before and 4-6 weeks after surgery. These 3 questionnaires will take 20 minutes to fill in. The fourth and fifth appointments will consist of Computed Tomogram (CT) and Magnetic Resonance Imaging (MRI) scans in our radiology department to assess cancer staging. These appointments will last about 1 hour 30 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Procedure: Structured responsive interval exercise training programme6 week structured responsive interval exercise training programme |
| Control group | Sham comparator | Other: Sham groupNegative, unsupervised, out of hospital control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of T3N+ rectal cancer
- above age of 18
- able to conduct a cardiopulmonary exercise test on a cycle ergometer
Key exclusion criteria (2 listed)
- unable to conduct a cardiopulmonary exercise test on a cycle ergometer
- metastatic disease
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 |
|---|---|---|
| Structured responsive interval exercise training programme | Procedure or surgery | Exercise group |
| Sham groupNO intervention in this group, only standard care (no exercise programme) | Other | Control group |
Primary outcome
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.
Time frame: Between baseline and week 0 and between week 0 at week 6 post-NACRT
1 secondary outcome
Alterations in mitochondrial energetics post-chemoradiotherapy and exercise
Time frame: Between baseline and week 0 and between week 0 and week 6 post-NACRT
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 6 May 2014.
- Derived from this study: PubMed 25478898West MA, Loughney L, Lythgoe D, Barben CP, Adams VL, Bimson WE, Grocott MP, Jack S, Kemp GJ. The effect of neoadjuvant chemoradiotherapy on whole-body physical fitness and skeletal muscle mitochondrial oxidative phosphorylation in vivo in locally advanced rectal cancer patients--an observational pilot study. PLoS One. 2014 Dec 5;9(12):e111526. doi: 10.1371/journal.pone.0111526. eCollection 2014.
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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 Early Phase 1 study testing Structured responsive interval exercise training programme in people with Locally Advanced Rectal Cancer, run by Michelle Mossa 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 3 inclusion and 2 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 6 May 2014. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery. (time frame: Between baseline and week 0 and between week 0 at week 6 post-NACRT). 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 NCT01859442, 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 6 May 2014.