Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Metastatic Colorectal Cancer; Toxicity Due to Chemotherapy; Dietary Modification; Cancer Cachexia
• Intervention / Treatment: Dietary supplement: NUTRIDRINK Compact Protein

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland
    • Recruiting
    • University Clinical Centre
    • Contact: Sylwia Malgorzewicz, MD, PhD; Phone Number: +48 58 3492724; Email: sylwiam@gumed.edu.pl
    • Principal Investigator: Sylwia Malgorzewicz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NUTRIDRINK Compact Protein; NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice	Dietary supplement: NUTRIDRINK Compact Protein; high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months); Other Names: Oral nutritional supplement
NO_INTERVENTION: without oral nutritional supplements; Dietary advice alone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Clinical Centre, Gdansk
• Collaborators: Nutricia Foundation
• Investigators: Principal Investigator: Sylwia Malgorzewicz, MD, PhD, University Clinical Centre, Gdansk, Poland

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Emaciation; Weight Loss; Cachexia
• Other Study ID Numbers: 01/2014/UCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: publication in nutritional and oncological journals, presentation on the congresses