Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
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|ClinicalTrials.gov Identifier: NCT02848807|
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
|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|
- 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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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
- 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)
- 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.
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
|Contact: Sylwia Malgorzewicz, MD, PhD||+48 58 firstname.lastname@example.org|
|University Clinical Centre||Recruiting|
|Contact: Sylwia Malgorzewicz, MD, PhD +48 58 3492724 email@example.com|
|Principal Investigator: Sylwia Malgorzewicz, MD, PhD|
|Principal Investigator:||Sylwia Malgorzewicz, MD, PhD||University Clinical Centre, Gdansk, Poland|