Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Zealand University Hospital48 enrolled

Overview

Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.

Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive The study is a part of the PREHAB study which is performed in collaboration with international centers. The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Colon Cancer Rectal Cancer Frailty

Interventions

PrehabilitationOTHER

A minimum of four weeks of prehabilitation with exercise three times a week, protein and vitamin supplements, dietitian consultation and medical optimization prior to surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing elective colorectal cancer surgery * WHO performance status I and II * Signed consent Exclusion Criteria: * Known metastatic disease * Unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments. * ASA 4 or 5 (American Society of Anesthesiologist Classification) * Neoadjuvant chemo- or radiation therapy * Renal failure III B or higher * Illiteracy or unable to write or understand Danish * Cognitive disabilities, which affects adherence e.g. severe dementia (MMSE score ≤17). * Withdrawal of consent.

Locations (2)

Zealand University Hospital

Køge, Danmark, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Danmark, Denmark

RECRUITING

Outcomes

Primary Outcomes

Quality of Recovery 15

Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome

Time frame: 3 days after surgery

Changes in physical fitness prior to surgery

Changes in VO2 max between baseline and prior to surgery

Time frame: Baseline, prior to surgery and 30 days after surgery

Complications

Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.

Time frame: 30 days after surgery

Changes in immunological function

Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)

Time frame: Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen

Secondary Outcomes

Disease specific quality of life - EORTC c30

European Organisation for Research and Treatment of Cancer Questionaire c 30 (EORTC c30). The EORTC c30 contains 6 domains which will each be assessed for mean changes in their cumulative score. The domains are physical function, role function, emotional function, pain, fatigue and global health. A higher value indicating a worse outcome

Time frame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

Disease specfic quality of life - EORTC c29

European Organisation for Research and Treatment of Cancer Questionaire c 29 (EORTC). The questionnaire contains 29 items, with a 4 point Likert scale for symptoms and 7 point Likert scale for quality of life and global health. For the 4 point Likert scale the higher the score the worse the outcome. For the 7 point likert scale higher values indicating a better outcome. Analysis will be performed for changes in individual symptoms and cumulative aggregation of scores will not be performed.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

Overall quality of life - SF-36

Short Form 36 question (SF-36) health questionnaire. The questionnaire contains eight domains: physical functioning, pain, limitations due to physical health problems, limitations due to personal or emotional problems, emotional well-being, social functioning, fatigue, and general health perceptions. Scores for each domain range from 0 to 100 and the analysis will be performed as mean difference between baseline and the following time frame. A higher value indicating a better outcome.

Time frame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

Psychological health - Depression - PHQ-9

Patient Health Questionnaire 9 (PHQ-9) Depression test. The PHQ-9 have a maximum of 27 points and a minimum of 0. The outcome is point change between baseline and following time frame. A higher value indicating a worse outcome

Time frame: the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery

Psychological health - General anxiety - GAD-7

General Anxiety Disorder 7-item (GAD-7). The questionnaire have a maximum of 21 points and a minium of 0. The outcome is the point change between baselin and the following time frame. A higher value indicating a worse outcome

Time frame: the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery

Physical function (6-MWT)

6-Minutes walk test. Measures how far the participant can walk in 6 minutes measured in meters