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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

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
Official Title  ICMJE Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Toxicity Due to Chemotherapy
  • Cancer Cachexia
  • Metastatic Colorectal Cancer
  • Quality of Life
  • Dietary Modification
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: NUTRIDRINK Compact Protein
    NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice
    Intervention: Dietary Supplement: NUTRIDRINK Compact Protein
  • No Intervention: without oral nutritional supplements
    Dietary advice alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848807
Other Study ID Numbers  ICMJE 01/2014/UCK
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: publication in nutritional and oncological journals, presentation on the congresses
Responsible Party University Clinical Centre, Gdansk
Study Sponsor  ICMJE University Clinical Centre, Gdansk
Collaborators  ICMJE Nutricia Foundation
Investigators  ICMJE
Principal Investigator: Sylwia Malgorzewicz, MD, PhD University Clinical Centre, Gdansk, Poland
PRS Account University Clinical Centre, Gdansk
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP