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Trial Title:
Exercise for Improving Radiotherapy Efficacy in Rectal Cancer
NCT ID:
NCT06292975
Condition:
Locally Advanced Rectal Carcinoma
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Exercise
Radiotherapy
Vigorous intensity aerobic interval exercise
Treatment efficacy.
Locally advanced rectal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Feasibility study
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Supervised Vigorous intensity aerobic interval exercise
Description:
7-weeks course of aerobic and resistance exercise, delivered 2 weeks before neoadjuvant
radiotherapy (NART), 1 week of NART and 4 weeks post NART.
Other name:
Unsupervised resistance exercise
Summary:
This is a single arm feasibility study of exercise for improving short- course
neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal
cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology
and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced
rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured
aerobic exercises and resistance training in the periods before, during and after their
radiotherapy treatment. The patients will be followed up for 6 months post short course
neoadjuvant radiotherapy, with a total of 3 assessment periods.
Detailed description:
This study will take place at Castle Hill Hospital, where the participants' usual care
will be given. The study will also recruit at this site. Patients, who have been
diagnosed with locally advanced rectal cancer (LARC) short-course radiotherapy (NART)
will be pre-screened for any obvious exclusions with those that are potentially eligible
approached by their clinical oncologist to discuss participation in these studies. If the
patient is agreeable, further contact will be made by a member of the research team for
further discussion. The aim is to include about 30 participants in this study. The
participant information sheet will be provided and any uncertainties about the study
raised by the potential participant will be addressed. The potential participant will be
given sufficient time, up to a week, to consider their participation in the study, as
typically, there is on average a 31-day period between decision to treat and start of
neoadjuvant oncological treatment. After all questions are answered and provided the
participant is willing to take part in the study, they will be asked to sign the consent
form to confirm participation.
Once a participant agrees to taking part, their medical history, and investigations
(performed as part of routine clinical care) will be reviewed. Each participant's data
from investigational phase for rectal cancer up to short-course NART completion and
re-assessment will be collected. Data on age, gender, stage of rectal cancer, and any
comorbidities will be collected from medical notes. Participants will then be invited for
a baseline assessment at Castle Hill Hospital in a designated risk assessed
rehabilitation gym.
In this baseline assessment, further personal details will be taken from the patient,
including height and weight measurements to calculate Body Mass Index (BMI), other
descriptive information such as ethnicity will also be taken. The Patient Reported
Outcome Measures (PROMs) will be completed either independently by participant or with
the help of a member of the research team if required by participant. Some of the
questionnaires, such as the European Organisation for Research and Treatment of Cancer
EORTC-QLQ-CR29 and Functional Assessment of Cancer Therapy - Colorectal (FACT-C),
contained in this study contain some questions that may be perceived to be intrusive.
They however are validated questionnaires that has previously been used in numerous
rectal cancer research studies. To mitigate embarrassment, participants will be
forewarned about the contents of these questionnaires and potential to cause
embarrassment. Participants will be reminded that their response will be anonymised.
Questions relating to stoma and sex life are presented much later in the questionnaires
where rapport may have already been established. Participants will be encouraged to
consult with their oncologist if the questionnaires prompt any treatment related problems
they may be experiencing.
Participants will also on this day, be provided an accelerometer to wear on 7 randomly
selected days at different timeframes of the study. Finally on this day an average of
three resting heart rates will be taken. The value of the average of the resting hear
rates will be used in calculating a heart rate reserve (HRR) of 60%, 70% and 80%. Using
the formula (HRmax-RHR) × exercise intensity (60-80%) + RHR, where HRmax is 220-Age as
found to be effective. This will form one of the main bases for exercise intensity, to
ensure individualisation of the supervised vigorous intensity interval training sessions.
The supervised hospital-based exercise will be delivered over a 7-week period. This is
because short-course neoadjuvant radiotherapy lasts 5-days in a week. This design allows
for a 2-week pre-neoadjuvant oncological and a 4-week post-neoadjuvant oncological
treatment. Exercise will involve an hour long, twice weekly vigorous intensity aerobic
interval exercise and twice weekly supported at-home resistance training, from 2 weeks
prior to the start of oncological treatment to the beginning of NART. In the week of
NART, participants will receive 5 consecutive days of vigorous intensity aerobic interval
training 1.5 hours before radiotherapy only. Following this week of short-course NART,
participants will return to receiving twice weekly vigorous intensity aerobic interval
exercise and twice weekly supported at-home resistance training, for four weeks. Vigorous
intensity aerobic interval exercise will be performed at 70-80% of heart rate reserve
(HRR).
The first supervised vigorous intensity interval training class will feature an induction
and orientation into the gym, facilities nearby, like a toilet and safety checks during
exercise classes. Participants will be encouraged to be proactive in expressive their
bodies response to the exercises and to seek help promptly if required. Participants will
also on this day, be provided an accelerometer to wear on the days for unsupervised
resistance training.
These supervised vigorous intensity interval training sessions will be delivered on an
individual basis, lasting up to 60-minutes, performed on a cycle ergometer, and
supervised by at least one trained exercise practitioner or a physiotherapist. The
sessions will include a 5-minute warm up and 5-minute cool down. The interval phase will
include up to 6 bouts of vigorous intensity interval training alternating between
5minutes of pedalling at up to 70-80% HRR and 2.5 minutes active rest, pedalling with no
resistance at less than 60% HRR.
At the end of the exercise phase of the studies their will be a post-exercise assessment
on the next working day of exercise completion, where all the information taken in the
baseline assessment will be collected for comparison. Participants will not be seen again
until their post-surgery phase, which will be 6 months from the start of NART . At this
stage, information about Pathological complete response(PCR) or Radiological complete
response (RCR) and tumour regression (TR) will be collected.
There will also be a semi-structured interview to explore participant satisfaction of the
trial and acceptability of the exercises. Notes will be taken during the interview. The
interview data will be coded and analysed via reflexive thematic analysis using the NVivo
qualitative analysis software. People approached about the study in clinic who choose not
to participant will be encouraged to discuss why they chose not to participate in a short
survey with questions adapted from the study by Dwyer and colleagues. Information from
this survey may be instrumental in adapting the study design appropriately to better
serve this patient group.
There may be one additional research visit if sufficient data cannot be obtained from the
medical notes. This will be face to face or via telephone, depending on participant
preference and every attempt will be made to coordinate this with participants
oncological appointment.
The total period of participation in the study for each patient will be at most 7 months,
this is with a gap between completion of exercise and 6-month review from start of
neoadjuvant oncological treatment. All research activities is planned to be completed
within 18 months of receiving approval from the Research Ethics Committee(REC).
This study design will allow us to determine the proportion of people in our region with
LARC who are willing to engage in structured outpatient exercise before, during and after
short-course NART. There are not sufficient safety data in United Kingdom (UK) based
subjects at present to justify incorporating exercise in all stages of the rectal cancer
care pathway according to the current guidelines. Additionally, this study will also
provide safety data by determining the proportion of LARC patients who are able to
complete supervised vigorous Intensity Interval training and unsupervised training at
home. The exploratory goals of these studies may provide indicative data on the impact of
vigorous intensity training on quality of life and short-course NART efficacy.
Data generated from the study will be aggregated, anonymised, and used for publication in
scientific journals and presented in abstract form at scientific meetings. All patient
identifiable information will be always kept confidential. Anonymised data may be
available to the scientific community following the end of the study. Data will be stored
confidentially at the university of Hull for a maximum of 5 years for future research use
if needed before it is fully destroyed. The management of the study will be overseen by
the chief investigator. Regular meetings will be held by the chief investigator and
members of the research team involved in the study to ensure all the correct steps are
being taken and to address any issues that could exist.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years or older
- Have been diagnosed with locally advanced rectal cancer using MRI (Magnetic
Resonance Imaging) and histological finding,
- Have been offered short-course neoadjuvant radiotherapy in the Queens Centre, Castle
Hill Hospital
- Willing and able to comply with all study requirements
- Able and willing to voluntarily give informed consent to take part.
Exclusion Criteria:
- Inability to understand basic written and spoken English, as research materials will
all be written in English.
- Any movement deficiencies limiting ability to engage in exercise.
- Impaired cognition and/or capacity limiting ability to provide informed consent.
- Cardiovascular and/or cardiopulmonary conditions that will impede ability to safely
perform exercise.
- Severe psychiatric disorders.
- With any other health condition which oncologists and research team agrees will
impede ability to safely perform exercises.
- Presence of metastatic cancer.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
February 2026
Lead sponsor:
Agency:
University of Hull
Agency class:
Other
Collaborator:
Agency:
Hull University Teaching Hospitals NHS Trust
Agency class:
Other
Source:
University of Hull
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06292975