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Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

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ClinicalTrials.gov Identifier: NCT02848807
Recruitment Status : Unknown
Verified July 2016 by University Clinical Centre, Gdansk.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
Nutricia Foundation
Information provided by (Responsible Party):
University Clinical Centre, Gdansk

Study Description
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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.

Condition or disease Intervention/treatment Phase
Toxicity Due to Chemotherapy Cancer Cachexia Metastatic Colorectal Cancer Quality of Life Dietary Modification Dietary Supplement: NUTRIDRINK Compact Protein Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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Arms and Interventions
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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 Name: Oral nutritional supplement
No Intervention: without oral nutritional supplements
Dietary advice alone


Outcome Measures
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Primary Outcome Measures :
  1. Chemotherapy-related toxicity during 12th week of observation [ Time Frame: 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 :
  1. Changes in the Nutritional status / metabolic status [ Time Frame: 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)


  2. Changes in the Quality of life and patients well-being [ Time Frame: 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.


  3. Changes in the Performance status [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848807


Contacts
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Contact: Sylwia Malgorzewicz, MD, PhD +48 58 3492724 sylwiam@gumed.edu.pl

Locations
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Poland
University Clinical Centre Recruiting
Gdansk, Poland
Contact: Sylwia Malgorzewicz, MD, PhD    +48 58 3492724    sylwiam@gumed.edu.pl   
Principal Investigator: Sylwia Malgorzewicz, MD, PhD         
Sponsors and Collaborators
University Clinical Centre, Gdansk
Nutricia Foundation
Investigators
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Principal Investigator: Sylwia Malgorzewicz, MD, PhD University Clinical Centre, Gdansk, Poland
More Information
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Responsible Party: University Clinical Centre, Gdansk
ClinicalTrials.gov Identifier: NCT02848807     History of Changes
Other Study ID Numbers: 01/2014/UCK
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication in nutritional and oncological journals, presentation on the congresses
Additional relevant MeSH terms:
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Cachexia
Emaciation
Weight Loss
 Body Weight Changes
Body Weight
Signs and Symptoms