CancerPopcornNCT05270577
Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
A study testing Prehabilitation in people with Cancer, run by Linkoeping University.
Trial summary
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2023
- 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
- Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.
Who cannot join
- Surgery is scheduled in less than 12 weeks.
- Paralytic or completely immobilized patient, condition making physical training impractical.
- Cognitive disability making participation impossible.
- Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.
- Conditions
- Cancer
- Being tested
- Prehabilitation, Standard care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
prehabilitation
Standard careOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop Receives: Other: Prehabilitation |
| Standard care | Active comparator | Standard preoperative recomendations Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test (6mwt)
6 minute walk test (6mwt)
Measured: 12 weeks
Secondary outcomes (22)
30 s chair stand test
30 s chair stand test
Measured: 12 weeks
Test of hand grip strength
Test of hand grip strength
Measured: 12 weeks
International Physical Activity Questionnaire
International Physical Activity Questionnaire
Measured: 12 weeks
Cardiopulmonary exercise test with ventilatory gas analysis
Cardiopulmonary exercise test with ventilatory gas analysis making it possible to calculate VOmax as well as other established measures of cardiopulmonary function
Measured: 12 weeks
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
Measured: 12 weeks
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
Measured: 12 weeks
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
Measured: 12 weeks
4-week point prevalence of smoking abstinence (among baseline smokers)
4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale
Measured: 12 weeks
Weekly alcohol consumption
Weekly alcohol consumption as reported in standard units
Measured: 12 weeks
Episodes of heavy drinking per month
Episodes of heavy drinking per month as reported in standard units at a single occation
Measured: 12 weeks
The most severe complication occurring
The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery
Measured: 90d after surgery
Sum of all complications in each patient (comprehensive complication index, CCI)
Sum of all complications in each patient (comprehensive complication index, CCI) occuring up to 90 days after surgery
Measured: 90d after surgery
Length of hospitalization
Length of hospitalization
Measured: 90d after surgery
Time to functional recovery of physical status as compared to baseline values
Defined as number of days after surgery until the patient has reached all of the following: being mobile at the preoperative level, having sufficient pain control with only oral or transdermal medication, being able to maintain food intake without intravenous fluids and not being in need of intravenous medications
Measured: 90d after surgery
Clinical Frailty Scale
Clinical Frailty Scale
Measured: 12 weeks
Grade of sarcopenia
Grade of sarcopenia
Measured: 12 weeks
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)
Measured: 90 days
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
Measured: 90 day after surgery
Proportion of patients not able to receive all treatment despite no dissemination of disease
Proportion of patients not able to receive all treatment despite no dissemination of disease
Measured: 90 day after surgery
Overall survival
Overall survival
Measured: 5 years
Quality of Life (QoL)
Quality of Life (QoL)
Measured: 2 years after surgery
Incremental cost-effectiveness ratio
Incremental cost-effectiveness ratio, calculated as the median cost divided by the quality adjusted life years obtained until 2 years after surgery
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bergthor Björnsson, Linkoeping University
- Investigators
- Bergthor Björnsson, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270577
- Sponsor's protocol ID
- Popcorn
- Acronym
- Popcorn
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
- ClinicalTrials.gov ID
- NCT05270577
- Acronym / sponsor ID
- Popcorn / Popcorn
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Mar 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.
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: PrehabilitationPrehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop |
| Standard care | Active comparator | Other: Standard careStandard preoperative recomendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.
Key exclusion criteria (4 listed)
- Surgery is scheduled in less than 12 weeks.
- Paralytic or completely immobilized patient, condition making physical training impractical.
- Cognitive disability making participation impossible.
- Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.
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 |
|---|---|---|
| Prehabilitationprehabilitation | Other | Prehabilitation |
| Standard careNo intervention | Other | Standard care |
Primary outcome
6 minute walk test (6mwt)
Time frame: 12 weeks
6 minute walk test (6mwt)
22 secondary outcomes
30 s chair stand test
Time frame: 12 weeks
Test of hand grip strength
Time frame: 12 weeks
International Physical Activity Questionnaire
Time frame: 12 weeks
Cardiopulmonary exercise test with ventilatory gas analysis
Time frame: 12 weeks
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
Time frame: 12 weeks
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
Time frame: 12 weeks
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
Time frame: 12 weeks
4-week point prevalence of smoking abstinence (among baseline smokers)
Time frame: 12 weeks
Weekly alcohol consumption
Time frame: 12 weeks
Episodes of heavy drinking per month
Time frame: 12 weeks
The most severe complication occurring
Time frame: 90d after surgery
Sum of all complications in each patient (comprehensive complication index, CCI)
Time frame: 90d after surgery
Length of hospitalization
Time frame: 90d after surgery
Time to functional recovery of physical status as compared to baseline values
Time frame: 90d after surgery
Clinical Frailty Scale
Time frame: 12 weeks
Grade of sarcopenia
Time frame: 12 weeks
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)
Time frame: 90 days
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
Time frame: 90 day after surgery
Proportion of patients not able to receive all treatment despite no dissemination of disease
Time frame: 90 day after surgery
Overall survival
Time frame: 5 years
Quality of Life (QoL)
Time frame: 2 years after surgery
Incremental cost-effectiveness ratio
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- 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.
Bergthor Björnsson, MD, PhD principal investigator
Linkoeping University
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cancer, run by Linkoeping University.
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 4 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Bergthor Björnsson, MD, PhD (+46703766890, bergthor.bjornsson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (6mwt) (time frame: 12 weeks). 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 Mar 2022.