Cancer Cachexia, Dietary Modification, Metastatic Colorectal Cancer, Quality of Life, Toxicity Due to Chemotherapy
Conditions
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
Interventions
DIETARY_SUPPLEMENTNUTRIDRINK Compact Protein
high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
Sponsors
Nutricia Foundation
University Clinical Centre, Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy-related toxicity during 12th week of observation | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Nutritional status / metabolic status | 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 | 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 | 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. |
Countries
Poland
Contacts
Primary ContactSylwia Malgorzewicz, MD, PhD
Outcome results
None listed