Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Cancer Clinical Trial

— Popcorn  

Official title:

Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270577
• Other study ID #: Popcorn
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Linkoeping University
• Contact: Bergthor Björnsson, MD, PhD
• Phone: +46703766890
• Email: bergthor.bjornsson[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Prehabilitation
prehabilitation
• Standard care
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test (6mwt)	6 minute walk test (6mwt)	12 weeks
Secondary	30 s chair stand test	30 s chair stand test	12 weeks
Secondary	Test of hand grip strength	Test of hand grip strength	12 weeks
Secondary	International Physical Activity Questionnaire	International Physical Activity Questionnaire	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)	Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)	12 weeks
Secondary	Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)	Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)	12 weeks
Secondary	4-week point prevalence of smoking abstinence (among baseline smokers)	4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale	12 weeks
Secondary	Weekly alcohol consumption	Weekly alcohol consumption as reported in standard units	12 weeks
Secondary	Episodes of heavy drinking per month	Episodes of heavy drinking per month as reported in standard units at a single occation	12 weeks
Secondary	The most severe complication occurring	The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery	90d after surgery
Secondary	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	90d after surgery
Secondary	Length of hospitalization	Length of hospitalization	90d after surgery
Secondary	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	90d after surgery
Secondary	Clinical Frailty Scale	Clinical Frailty Scale	12 weeks
Secondary	Grade of sarcopenia	Grade of sarcopenia	12 weeks
Secondary	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)	90 days
Secondary	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)	90 day after surgery
Secondary	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	90 day after surgery
Secondary	Overall survival	Overall survival	5 years
Secondary	Quality of Life (QoL)	Quality of Life (QoL)	2 years after surgery
Secondary	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	2 years after surgery