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Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Primary Purpose

Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
NUTRIDRINK Compact Protein
Sponsored by
University Clinical Centre, Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Toxicity Due to Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NUTRIDRINK Compact Protein

without oral nutritional supplements

Arm Description

NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice

Dietary advice alone

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
July 16, 2014
Last Updated
July 25, 2016
Sponsor
University Clinical Centre, Gdansk
Collaborators
Nutricia Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02848807
Brief Title
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
Official Title
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Clinical Centre, Gdansk
Collaborators
Nutricia Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxicity Due to Chemotherapy, Cancer Cachexia, Metastatic Colorectal Cancer, Quality of Life, Dietary Modification

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NUTRIDRINK Compact Protein
Arm Type
Active Comparator
Arm Description
NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice
Arm Title
without oral nutritional supplements
Arm Type
No Intervention
Arm Description
Dietary advice alone
Intervention Type
Dietary Supplement
Intervention Name(s)
NUTRIDRINK Compact Protein
Other Intervention Name(s)
Oral nutritional supplement
Intervention Description
high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
Primary Outcome Measure Information:
Title
Chemotherapy-related toxicity during 12th week of observation
Description
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)
Time Frame
at baseline and after 12th week
Secondary Outcome Measure Information:
Title
Changes in the Nutritional status / metabolic status
Description
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)
Time Frame
at baseline and after 12th week
Title
Changes in the Quality of life and patients well-being
Description
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.
Time Frame
at baseline and after 12th week
Title
Changes in the Performance status
Description
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.
Time Frame
at baseline and after 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylwia Malgorzewicz, MD, PhD
Phone
+48 58 3492724
Email
sylwiam@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylwia Malgorzewicz, MD, PhD
Organizational Affiliation
University Clinical Centre, Gdansk, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinical Centre
City
Gdansk
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylwia Malgorzewicz, MD, PhD
Phone
+48 58 3492724
Email
sylwiam@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Sylwia Malgorzewicz, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
publication in nutritional and oncological journals, presentation on the congresses

Learn more about this trial

Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

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