Cancer-related Malnutrition
Conditions
Brief summary
This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates.
Interventions
None listed
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or subject's legally acceptable representative (LAR) has voluntarily signed and dated an ICF approved by an IEC, or any other applicable privacy authorization prior to any participation in the study. * Ambulatory and inpatient subject. * Subject recently (within the last month) or newly diagnosed to have metastatic or non-metastatic gastric, colon and lung cancer. * Subject is recently receiving chemotherapy or recently prescribed to begin chemotherapy treatment per standard of care (within the last month) or candidates who will receive chemotherapy. * Subject has a life expectancy greater than 6 months.
Exclusion criteria
* Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, any other psychological condition, serious illness or medical condition that may interfere with study completion. * Subject has malignant tumors other than treated DCIS, fully treated non-melanoma skin cancer, curatively resected in-situ cervical cancer or other curative treated tumors (except stomach, colon and lung cancer) for \> 5 years. * Subject has bone marrow metastasis. * Subject is lactating. * Subject is participating in another study that has not been approved as a concomitant study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PG-SGA | Baseline to week 24 | Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished |
| RMAPP | Baseline to week 24 | A tool to screen patients for risk of malnutrition and/or sarcopenia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline | Height in CM |
| Calf Circumference | Baseline to 24 weeks | Change in calf circumference |
| Fat Free Mass Index | Baseline to week 24 | Evaluate Muscle Mass in relation to height and weight |
| Body Mass Index | Baseline to week 24 | As calculated from height and weight |
| Handgrip Strength | Baseline to 24 weeks | Change in handgrip dynamometer as measured in kilograms |
| Walking Speed | Baseline to 24 weeks | Change in Gait Speed over 6 meter walk |
| EORTC QLQ-C30 | Baseline to 12 months | Questionnaire with 28 questions from 1 to 4 with higher number is more favorable and 2 overall score questions from very poor to excellent |
| Weight | Baseline to 24 weeks | Change in weight |
Other
| Measure | Time frame | Description |
|---|---|---|
| HealthCare Resource Utilization | Baseline to 12 months | Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits |
Countries
Turkey (Türkiye)
Outcome results
None listed