Clinical trial NCT04520737: Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
Official title: Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Neoadjuvant Therapy
Liver Metastases
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participant will be randomized (1:1) using seed, a Stata's random-number generated function. The subjects will be allocated into one of the two groups of the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented.

The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.

Detailed description: The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.

MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.

Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent obtained from subject to participate in the study.

Exclusion Criteria:

* Age \<18 years
* ASA health class status IV-V
* Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
* Medical contraindication to perform exercise
* Inability to obtain informed consent

Primary outcomes:
measure: Physical Fitness- 6MWT
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Secondary outcomes:
measure: Postoperative complications- Clavien-Dindo classification
timeFrame: Through study completion, up to one year postoperative
measure: Postoperative complications- CCI
timeFrame: Through study completion, up to one year postoperative
measure: Postoperative hospital length of stay
timeFrame: Postoperative period: assessed up to the first year postoperative
measure: Readmissions rate
timeFrame: Postoperative period: Up to 30 postoperative days
measure: Functional capacity- 30CST
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
measure: Health-related quality of life- SF-36
timeFrame: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
measure: Psychological health- HADS
timeFrame: Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
measure: Functional capacity- Handgrip strength
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
measure: Nutritional status- PG-SGA
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
measure: Nutritional status- BMI
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
measure: Nutritional status- BIA
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
measure: Nutritional status- UMA
timeFrame: Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
Study officials:
affiliation: Hospital Universitari de Tarragona Joan XXIII
name: Laia Estalella, PhD
role: PRINCIPAL_INVESTIGATOR
References: