Fit for Surgery. Multimodal Prehabilitation in Colorectal Cancer Patients

Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.

Sponsors

Lead Sponsor: Zealand University Hospital

Source Zealand University Hospital
Brief Summary

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

Detailed Description

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.

Overall Status Recruiting
Start Date May 1, 2019
Completion Date August 1, 2022
Primary Completion Date December 1, 2021
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Quality of Recovery 15 3 days after surgery
Changes in physical fitness prior to surgery Baseline, prior to surgery and 30 days after surgery
Complications 30 days after surgery
Changes in immunological function Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen
Secondary Outcome
Measure Time Frame
Disease specific quality of life - EORTC c30 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 the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Overall quality of life - SF-36 the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Psychological health - Depression - PHQ-9 the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery
Psychological health - General anxiety - GAD-7 the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery
Physical function (6-MWT) The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (STS) The day prior to surgery, 30 days after surgery, and 60 days after surgery.
Physical function (Stair climb test) The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (Leg extension test) The day prior to surgery, 30 days after surgery, and 60 days after surgery
Physical function (Hand grip strength) The day prior to surgery, 30 days after surgery, and 60 days after surgery
Nutritional status The day prior to surgery, 30 days after surgery, and 60 days after surgery
Remission and cancer free survival 5 years
Enrollment 48
Condition
Intervention

Intervention Type: Other

Intervention Name: Prehabilitation

Description: 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.

Arm Group Label: Prehabilitation

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Status: Contact:
Zealand University Hospital | Køge, Danmark, 4600, Denmark Recruiting Rasmus D Bojesen, MD 26193789 [email protected]
Slagelse Hospital | Slagelse, Danmark, 4200, Denmark Recruiting Rasmus D Bojesen, MD 26193789 [email protected]
Location Countries

Denmark

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Prehabilitation

Type: Experimental

Description: Patients receive multi-modal prehabilitation with exercise three times weekly, protein supplements, vitamin supplements, dietitian consultation and medical optimization prior to surgery. A minimum of four weeks.

Label: Standard of Care

Type: No Intervention

Description: Receives standard of care

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized Clinical Trial with an intervention arm and a standard of care arm.

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.

Source: ClinicalTrials.gov