CancerNCT05547594
Prehabilitation in Patients With Cancer and Type 2 Diabetes
A study testing Multimodal surgical prehabilitation in people with Cancer and Type 2 Diabetes, run by University of Greenwich at 2 sites in United Kingdom.
Trial summary
Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Type 2 Diabetes
- What is being tested?
- Multimodal surgical prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Jan 2024to 30 Apr 2025
- 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
- Capacity to give consent
- Newly diagnosed with cancer
- Non-insulin-dependent Type 2 diabetes
- Awaiting surgery for cancer
Who cannot join
- Medical contraindication to engage in physical activity
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm (Office SF112B)
Eltham, England, SE9 2BT
Fernando Naclerio, PhD, 0044 2083 318441, f.j.naclerio@greenwich.ac.uk
Roberto Laza-Cagigas, MSc, 0044 7597 058406, r.lazacagigas@greenwich.ac.uk
- Recruiting
King's College Hospital
London
Roberto Laza, PhD/MPhil, R.LazaCagigas@greenwich.ac.uk
About this study
Official title: Impact of a Multimodal Prehabilitation Programme on Markers of Health, Quality of Life and the Short and Long Post-surgery Recovery Period in Cancer Patients With Type 2 Diabetes
Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases.
Although the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown.
This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.
Read the detailed description
This study will take advantage of already existing infrastructures, by approaching a single National Health Service (NHS) hospital in England that is already run a prehabilitation service for its patients. This study will analyse the effect of the prehabilitation programme on a specific group of patients, those with cancer and Type 2 diabetes who do not require insulin as part of their diabetes treatment and who are waiting for surgery.
Surgical prehabilitation refers to interventions done before surgery to increase the patient's overall health and fitness so that they can better cope with the stress of surgery, avoid complications/reduce, and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle, including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation.
Multimodal prehabilitation programmes may use a combination of telehealth and face-to-face delivery to provide flexibility according to the preferences of the patients.
The collaboration between the University of Greenwich and NHS will provide an opportunity to measure the impact of the programme on those participants with Type 2 diabetes, beyond variables like weight and fasting blood glucose (i.e., body composition, glycaemic behaviour, blood insulin concentration, immune system markers…).
The hospital prehabilitation team will identify potential study participants (patients with Type 2 diabetes who do not use insulin awaiting surgery) amongst those referred to their service. The prehabilitation team will present the idea of the study to the potential participants and will ask for consent to share their contact details with the sponsor. If consent is received, the researcher will contact them to briefly present to them the possibility of joining the study. This 1st contact will be overseen by the Chief Investigator.
Those who accept to participate in the study will be allocated into 2 different groups. Patients undergoing prehabilitation will join the prehabilitation group of the study, while those declining prehabilitation will join the control group.
Regardless of the group, all patients will undergo the same number of interactions with the researcher:
- Interview and consent The candidate will be provided with the patient information sheet and explained what they can expect and what will be expected from them if they decide to participate in the study. Candidates will be able to ask questions and, in case they decide to participate, they will sign the participant consent form.
- Baseline/initial assessment The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place a few weeks before surgery before the patient starts prehabilitation (prehab group) or upon joining the study (control group).
- Assessment before surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place a few days before surgery.
- Assessment 6 weeks after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place 6 weeks after surgery, a time that generally allows the participant to recover enough to be able to move around comfortably and perform some light physical activity
- Assessment 6 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place 6 months after surgery, a time by which the patient will generally be fully recovered, potentially reaching their pre-surgical status, and will have been able to resume their regular day-to-day activity
- Assessment 12 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.
Both groups (prehabilitation and control) will undergo the same previously described assessments. This will allow us to understand and compare how the measured variables change through time in both groups (prehabilitation vs control).
The investigators hypothesise that prehabilitation will improve patients' physical performance prior to surgery and will provide them with a range of tools to help them recover faster and manage their overall health better (including their diabetes control) for at least one year after surgery.
- Conditions
- Cancer, Type 2 Diabetes
- Being tested
- Multimodal surgical prehabilitation
- Keywords
- cancer, Type 2 diabetes, surgery, prehabilitation, recovery, exercise, nutrition, protein, anxiety, quality of life, physical performance
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Type 2, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal surgical prehabilitationBehavioural
Participants will be encouraged to engage in regular physical activity (endurance and resistance exercise), eat healthily and undergo cognitive behavioural therapy (the latter only if required) during the weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Arm undergoing multimodal prehabilitation (physical activity, nutritional education and anxiety management) during the weeks leading up to surgery Receives: Behavioral: Multimodal surgical prehabilitation |
| Standard of care | No intervention | Arm receiving standard of care (no prehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery
Group of measures that combines the results of the gait speed, chair stand and balance tests, with scores ranging from 0 (worst performance) to 12 (best performance).
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Secondary outcomes (6)
Changes in fasting glucose at different time points from baseline to 1 year after surgery
Blood fasting glucose obtained via finger prick
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in fasting insulin at different time points from baseline to 1 year after surgery
Blood fasting insulin obtained via finger prick
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in BMI at different time points from baseline to 1 year after surgery
Body mass index
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in waist circumference at different time points from baseline to 1 year after surgery
Waist circumference
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in hip circumference at different time points from baseline to 1 year after surgery
Hip circumferences
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in Patient Health Questionnaire-9 (PHQ-9) at different time points from baseline to 1 year after surgery
Self-administered questionnaires to assess depression severity, with scores ranging from 0 (no depression) to 27 (severe depression)
Measured: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start18 Jan 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
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 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Fernando Naclerio, PhD, Principal investigator, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547594
- Sponsor's protocol ID
- UoG_2022_CT2D_Prehab
- Status last verified
- May 2024
- First submitted
- 12 Sep 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu F, Rotimi O, Laza-Cagigas R, Rampal T. The Feasibility and Effects of a Telehealth-Delivered Home-Based Prehabilitation Program for Cancer Patients during the Pandemic. Curr Oncol. 2021 Jun 17;28(3):2248-2259. doi: 10.3390/curroncol28030207.
PubMed 34204531
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multimodal Prehabilitation Programme on Markers of Health, Quality of Life and the Short and Long Post-surgery Recovery Period in Cancer Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05547594
- Acronym / sponsor ID
- UoG_2022_CT2D_Prehab
- Conditions
- Cancer, Type 2 Diabetes
- Keywords
- cancer, Type 2 diabetes, surgery, prehabilitation, recovery, exercise, nutrition, protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Sep 2022 (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.
Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases.
Although the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown.
This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.
Detailed description
This study will take advantage of already existing infrastructures, by approaching a single National Health Service (NHS) hospital in England that is already run a prehabilitation service for its patients. This study will analyse the effect of the prehabilitation programme on a specific group of patients, those with cancer and Type 2 diabetes who do not require insulin as part of their diabetes treatment and who are waiting for surgery.
Surgical prehabilitation refers to interventions done before surgery to increase the patient's overall health and fitness so that they can better cope with the stress of surgery, avoid complications/reduce, and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle, including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation.
Multimodal prehabilitation programmes may use a combination of telehealth and face-to-face delivery to provide flexibility according to the preferences of the patients.
The collaboration between the University of Greenwich and NHS will provide an opportunity to measure the impact of the programme on those participants with Type 2 diabetes, beyond variables like weight and fasting blood glucose (i.e., body composition, glycaemic behaviour, blood insulin concentration, immune system markers…).
The hospital prehabilitation team will identify potential study participants (patients with Type 2 diabetes who do not use insulin awaiting surgery) amongst those referred to their service. The prehabilitation team will present the idea of the study to the potential participants and will ask for consent to share their contact details with the sponsor. If consent is received, the researcher will contact them to briefly present to them the possibility of joining the study. This 1st contact will be overseen by the Chief Investigator.
Those who accept to participate in the study will be allocated into 2 different groups. Patients undergoing prehabilitation will join the prehabilitation group of the study, while those declining prehabilitation will join the control group.
Regardless of the group, all patients will undergo the same number of interactions with the researcher:
- Interview and consent The candidate will be provided with the patient information sheet and explained what they can expect and what will be expected from them if they decide to participate in the study. Candidates will be able to ask questions and, in case they decide to participate, they will sign the participant consent form.
- Baseline/initial assessment The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place a few weeks before surgery before the patient starts prehabilitation (prehab group) or upon joining the study (control group).
- Assessment before surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place a few days before surgery.
- Assessment 6 weeks after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place 6 weeks after surgery, a time that generally allows the participant to recover enough to be able to move around comfortably and perform some light physical activity
- Assessment 6 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers. This assessment will take place 6 months after surgery, a time by which the patient will generally be fully recovered, potentially reaching their pre-surgical status, and will have been able to resume their regular day-to-day activity
- Assessment 12 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.
Both groups (prehabilitation and control) will undergo the same previously described assessments. This will allow us to understand and compare how the measured variables change through time in both groups (prehabilitation vs control).
The investigators hypothesise that prehabilitation will improve patients' physical performance prior to surgery and will provide them with a range of tools to help them recover faster and manage their overall health better (including their diabetes control) for at least one year after surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Multimodal surgical prehabilitationArm undergoing multimodal prehabilitation (physical activity, nutritional education and anxiety management) during the weeks leading up to surgery |
| Standard of care | No intervention | –Arm receiving standard of care (no prehabilitation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capacity to give consent
- Newly diagnosed with cancer
- Non-insulin-dependent Type 2 diabetes
- Awaiting surgery for cancer
Key exclusion criteria (1 listed)
- Medical contraindication to engage in physical activity
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 |
|---|---|---|
| Multimodal surgical prehabilitationParticipants will be encouraged to engage in regular physical activity (endurance and resistance exercise), eat healthily and undergo cognitive behavioural therapy (the latter only if required) during the weeks prior to surgery. | Behavioural | Prehabilitation |
Primary outcome
Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Group of measures that combines the results of the gait speed, chair stand and balance tests, with scores ranging from 0 (worst performance) to 12 (best performance).
6 secondary outcomes
Changes in fasting glucose at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in fasting insulin at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in BMI at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in waist circumference at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in hip circumference at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Changes in Patient Health Questionnaire-9 (PHQ-9) at different time points from baseline to 1 year after surgery
Time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Results publication: PubMed 34204531Wu F, Rotimi O, Laza-Cagigas R, Rampal T. The Feasibility and Effects of a Telehealth-Delivered Home-Based Prehabilitation Program for Cancer Patients during the Pandemic. Curr Oncol. 2021 Jun 17;28(3):2248-2259. doi: 10.3390/curroncol28030207.
- Individual participant dataSharing planned: No
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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.
Fernando Naclerio, PhD principal investigator
University of Greenwich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal surgical prehabilitation in people with Cancer and Type 2 Diabetes, run by University of Greenwich at 2 sites 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 4 inclusion and 1 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Fernando Naclerio, PhD (0044 2083 318441, f.j.naclerio@greenwich.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery (time frame: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery). 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 NCT05547594, 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 28 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.