Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Not Applicable

• Conditions: Dietary Modification; Cancer Cachexia; Toxicity Due to Chemotherapy; Metastatic Colorectal Cancer; Quality of Life
• Interventions: Dietary Supplement: NUTRIDRINK Compact Protein

• Registration Number: NCT02848807
• Lead Sponsor: University Clinical Centre, Gdansk

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2014-07-16
• Study Start: 2014-09
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NUTRIDRINK Compact Protein	NUTRIDRINK Compact Protein	NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice

Primary Outcome Measures

Name	Time	Method
Chemotherapy-related toxicity during 12th week of observation	at baseline and after 12th week	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)

Secondary Outcome Measures

Name	Time	Method
Changes in the Nutritional status / metabolic status	at baseline and after 12th week	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)
Changes in the Performance status	at baseline and after 12th week	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.
Changes in the Quality of life and patients well-being	at baseline and after 12th week	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.

Trial Locations

Locations (1)

University Clinical Centre; 🇵🇱 Gdansk, Poland