Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Study Overview
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Brief Summary
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Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Detailed Description
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Other endpoints: to determine whether high protein ONS influence on the nutritional status to determine whether high protein ONS influence on the quality of life to determine whether high protein ONS influence on the performance status to determine high protein ONS tolerability / ONS intake compliance

Official Title
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Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study

Conditions
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Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer, Quality of Life, Dietary Modification

Intervention / Treatment
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* Dietary Supplement: NUTRIDRINK Compact Protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological confirmed diagnosis of CRC in clinical stage IV successful qualification to chemotherapy performance status at least 80% according to Karnofsky scale and <2 according to WHO/ECOG scale cancer-related asymptomatic precachexia diagnosed absence of contraindications to oral nutrition and practicable realization of oral nutrition absence of severe, decompensated concomitant diseases signed informed consent for the participation in the study Exclusion Criteria: diagnosis of a malignant neoplasm in clinical stage I-III disqualification from oncologic treatment cancer cachexia or cancer anorexia-cachexia syndrome poor performance status contraindications to oral nutrition or to high protein nutrition regular nutritional support at the moment of qualification to the study patient incompliance at the moment of qualification to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NUTRIDRINK Compact Protein<br>NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice | Dietary Supplement: NUTRIDRINK Compact Protein<br>* high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)<br>* Other names: Oral nutritional supplement;|
| No Intervention: without oral nutritional supplements<br>Dietary advice alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy-related toxicity during 12th week of observation | graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks) | at baseline and after 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Nutritional status / metabolic status | the assessment according to Nutritional Risk Screening 2002 (NRS 2002), Subjective Global Assessment (SGA), body mass, body mass index (BMI), VAS for appetite, albumin, prealbumin, triglycerides, total cholesterol, fasting blood glucose, C-reactive protein (CRP), ferritin, complete blood count. Body mass (in kg) will measure by the scales (Tanita BC 420). Hight ( in cm) measure by Stadiometer (Tanita) Body mass index calculation (BMI) on the basis of the following formula: BMI = body weight / height2 (kg/m2). VAS for appetite is 100-mm line where 0 mm means I had no appetite at all and 100 mm means My appetite was very good. Laboratory parameters will measured by routine laboratory methods. All results will be compared between study groups (ONS vs without ONS) at the same time point (eg. baseline group ONS vs baseline group without ONS) | at baseline and after 12th week | 
| Changes in the Quality of life and patients well-being | FAACT-ESPEN score Version 4 (Functional Assessment of Anorexia/Cachexia Therapy questionnaire) is a measure of the quality of life and it is completed by a patient, it has a total of 42 questions. Patients mark 0 (none) - 4 (very much) for each question. This tool consists of five subscales: functional well-being (7 items), physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and other aspects, including appetite (13 items). The maximum score is 168. The lower the score, the lower overall quality of life. | at baseline and after 12th week | 
| Changes in the Performance status | To performance status assessment will be used Kornofsky scale and ECOG scale. The Karnofsky score allows to quantify the overall state and quality of life of a patient with neoplastic disease who qualifies to receive chemotherapy. The score has a range from 0 to 100, where 100 represents the ideal state and 0 - death. The Eastern Cooperative Oncology Group(ECOG) score runs from 0 to 5, with 0 denoting perfect health and 5 death. | at baseline and after 12th week |