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.

Multidisciplinary Prehabilitation and Postoperative Rehabilitation in Patients Undergoing Resection of Colon Cancer

Colon Cancer

Postoperative Complications

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.

Prehabilitation program (4 week before the surgery)

Postoperative program (12 week after the surgery)

Usual Care

Multidisciplinary Prehabilitation and Postoperative Rehabilitation for Avoiding Complications in Patients Undergoing Resection of Colon Cancer: ONCOFIT Study

Post-surgery complications determined by the Comprehensive Complication Index (CCI). Minimum value: 0 // Maximum value: no upper limit. Higher scores mean a worse outcome.

Principal Investigator

Electronic medical records will be used to register data regarding primary and total prolonged hospital length of stay.

Electronic medical records will be used to register data regarding readmissions.

Electronic medical records will be used to register data regarding emergency department appointments.

Cardiorespiratory fitness measured by the 6-minute walking test (6MWT) distance, expresed in total m.

Muscular strength assessed by handgrip strength. Handgrip strength will be determined using a digital hand dynamometer and expressed as total kg.

The 36-Item Short Form Health Survey questionnaire (SF-36). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.

The Beck Depression Inventory-II questionnaire. Minimum value: 0 // Maximum value: 63. Higher scores mean a worse outcome.

The State-Trait Anxiety Inventory (STAI). Minimum value: 20 // Maximum value: 80. Higher scores mean a worse outcome.

The Life Orientation Test-Revised. Minimum value: 0 // Maximum value: 24. Higher scores mean a better outcome.

The Positive and Negative Affect Schedule (PANAS). Positive affect: Minimum value: 10 // Maximum value: 50. Higher scores mean a better outcome. Negative affect: Minimum value: 10 // Maximum value: 50. Higher scores mean a worse outcome.

The Satisfaction With Life Scale. Minimum value: 5 // Maximum value: 35. Higher scores mean a better outcome.

The Trait Meta-Mood Scale (TMMS-24) is a 24-item self-report instrument with three subscales measuring three key aspects of perceived emotional intelligence: Attention, Clarity and Repair. Each of these three subscales consists of eight items with a 5-point Likert response format (ranging from 1 to 5). Subscale total scores are obtained by summing responses to all items and thus range from 8 to 40, with higher scores indicating greater level of the characteristic assessed.

Neck, waist and hip circumferences will be assessed with an anthropometric tape measure (cm).

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Bone mineral density in g/cm2.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Lean mass in kg.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Fat mass in kg.

Body composition assessment will be obtained through a full-body dual energy X-ray absorptiometry scanner. Visceral adipose tissue in kg.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the glycemic profile. We will obtain plasma glucose (mg/dL) and insulin (mg/dL) levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the lipid profile.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hepatic transaminases levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the red cells levels.

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the immunological blood profiles. The following parameters will be obtained: Leukocytes (10*3 uL), Neutrophils (10*3 uL), Lymphocytes (10*3 uL), Monocytes (10*3 uL), Eosinophils (10*3 uL), Basophils (10*3 uL) and LUC cells (10*3 uL).

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the inflammatory factors levels (PCR, leptin, adiponectin, resistin, IL 6, IL 10 and PAI 1; all of them expressed as pg/mL)

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the renal function parameters (creatinine and urea; both will be expressed in mg/dL)

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the tumour markers levels (CA 19-9, CA 242, CA 72-4, TPA and TPS; all will be expressed as pg/mL))

Blood samples will be drawn from patient' antecubital vein in a supine position during the morning after an overnight fasting to assess the hormones levels (T3, T4, testosterone, cortisol, estrogens and DHEAs; all will be expressed as pg/mL))

The investigators will also asses systolic and diastolic blood pressure in the right arm at rest.

The investigators will calculate the homeostatic model assessment of insulin resistance index (HOMA). HOMA index was calculated as follows: (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405.

The investigators will calculate the fatty liver index (FLI) as a validated surrogate marker of non-alcoholic fatty liver disease.

The investigators will calculate a cardiometabolic risk score based on the International Diabetes Federation (IDF) criteria. The cardiometabolic risk score is a continuous variable with a mean of 0 and a standard deviation of 1 by definition, with lower scores denoting a more favorable profile.

The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts. Minimum value = 0 min/day of physical activity // Maximum value = 1440 min/day of physical activity. Higher scores imply a more physically active pattern.

A food frequency questionnaire (FFQ) conducted by a trained nutritionist. Based on dietary data from the FFQ, the investigators will calculate the Mediterranean Diet Score. Minimum value: 0 // Maximum value: 14. Higher scores mean a better outcome.

A seven-day self-reported tobacco and alcohol consumption logs will be used to determine smoking and alcohol intake registering total number of cigarettes and alcoholic units/day, time and situation in which both are consumed and cigarette type of alcoholic drink.

The Fagerström Test for Nicotine Dependence will be used to measure patients' nicotine dependence. Minimum value: 0 // Maximum value: 10. Higher scores mean a worse outcome.

Sleep quality will be determined by the Pittsburgh Sleep Quality Index (PSQI) scale. PSQI global score ranges from 0 to 21, with a score higher than 5 indicating poor sleep quality

A fecal sample (50-60 g) will be obtained and analyzed.

Usual care group will follow the usual institutional pre-surgery care..

PPP group will include 3 complementary modules: (i) supervised physical exercise, (ii) dietary behavior change, and (iii) psychological support.

Multidisciplinary Prehabilitation and Postoperative Rehabilitation in Patients Undergoing Resection of Colon Cancer

About this trial

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Placebo

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