Clinical trial NCT05379205: Multidisciplinary Prehabilitation and Postoperative Rehabilitation in Patients Undergoing Resection of Colon Cancer
Official title: Multidisciplinary Prehabilitation and Postoperative Rehabilitation for Avoiding Complications in Patients Undergoing Resection of Colon Cancer: ONCOFIT Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colon Cancer
Postoperative Complications
Keywords: Post-surgery complications
Multidisciplinary intervention
Exercise
Dietary behaviour
Psychological support
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Clinico Universitario San Cecilio
name: Universidad de Córdoba
First posted: 2022-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary prehabilitation + postoperative program on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care.

Detailed description: Nowadays, colon cancer is one of the most common types of tumors worldwide being surgical resection the elective therapy for its curation. However, a surgery is a stressful procedure that may involve several postoperative complications. Risk factors for such undesirable events are closely related to lifestyle issues including decreased physical activity levels or dietary unhealthy habits. Recent studies have suggested that the implementation of multidisciplinary prehabilitation and postoperative interventions based on lifestyle habits may be a potential strategy for accelerate post-surgical recovery. To the best of our knowledge, the combined effect of a Prehabilitation + Postoperative Programs (PPP) on post-surgery complications and functional capacity of patients undergoing resection of colon cancer remains unclear. ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary PPP on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care. Primary and secondary endpoints will be assessed at baseline, at preoperative conditions, at the end of the PPP intervention and 1-year post-surgery, including: post-surgery complications, prolonged hospital length of stay, readmissions and emergency department call within 1-year after surgery, functional capacity, patient' reported outcome measures targeted, anthropometry and body composition, clinical markers, physical activity levels and sedentariness, dietary habits, others unhealthy habits, sleep quality and fecal microbiota diversity and composition. Considering the feasibility of the present intervention in a real-life scenario, ONCOFIT will contribute to the standardization of a cost-effective strategy for preventing and improving health-related consequences in patients undergoing resection of colon cancer with an important clinical and economic impact, not only in the scientific community but also in the clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients older than 40 years
* Diagnostic of nonmetastatic colon cancer (i.e., including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
* Not participating in a nutritional/ dietary intervention
* Being physical inactive (i.e., not to be participating in any physical exercise program in the last 3 months, or performing less than 600 metabolic equivalents (METS)/week of moderate-vigorous physical activity).
* To be capable and willing to provide informed consent
* Not to suffer from any specific condition that may impede testing of the study hypothesis or make it unsafe to engage in the multidisciplinary intervention (i.e., determined by the research staff).

Exclusion Criteria:

* Medical contraindication for being engaged in an exercise or dietary program.
* Additional surgery planned within the 3-month intervention
* History of another primary invasive cancer
* Planning to receive adjuvant chemotherapy
* To be pregnant
* To present any of the following cardiac conditions: (i) myocardial infarction or coronary revascularization procedure within prior 3 months, (ii) uncontrolled hypertension (i.e., systolic ≥180 mmHg or diastolic ≥100 mmHg), (iii) uncontrolled arrhythmias (iv) valvular disease clinically significant, (v) decompensated heart failure or (vi) to suffer from known aortic aneurysm.

Primary outcomes:
measure: Post-surgery complications.
timeFrame: 1-year post-surgery (i.e., week 57)
measure: Post-surgery complications.
timeFrame: 12 weeks after surgery (i.e., week 17)
Secondary outcomes:
measure: Additional surgery-derived events.
timeFrame: 1-year post-surgery (i.e., week 57).
measure: Additional surgery-derived events.
timeFrame: 1-year post-surgery (i.e., week 57).
measure: Additional surgery-derived events.
timeFrame: 1-year post-surgery (i.e., week 57).
measure: Cardiorespiratory fitness
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Muscular strength
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Health-related quality of life.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Self-scored depression inventory
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Trait and state anxiety
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Dispositional level of optimism
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Positive and negative affect
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Satisfaction With Life
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Perceived emotional intelligence
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Weight
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Height
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Neck, waist and hip circumferences.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Bone mineral density
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Lean mass
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Fat mass
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Visceral adipose tissue
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Glycemic profile
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Lipid profile
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Hepatic transaminases
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Red cells
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Immunological blood profiles
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Inflammatory factors
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Renal function parameters
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Tumour markers
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Hormones
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Blood pressure.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: HOMA index.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: FLI index.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Cardiometabolic risk.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Physical activity and sedentariness.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Dietary habits.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Others unhealthy habits.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Nicotine dependence.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Sleep quality.
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
measure: Fecal microbiota analysis
timeFrame: Baseline (week 0), at preoperative conditions (week 5), at the end of the PPP intervention (week 17) and 1-year post-surgery (week 57).
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto Mixto Universitario Deporte y Salud (IMUDS)
state: Andalucía
Study officials:
affiliation: Universidad de Granada
name: Francisco J Amaro-Gahete, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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