• Increase Font Size
  • Decrease Font Size
  • View as PDF

ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Gioulbasanis I, Georgoulias P, Vlachostergios PJ, Baracos V, Ghosh S, Giannousi Z, Papandreou CN, Mavroudis D, Georgoulias V. Mini Nutritional Assessment (MNA) and biochemical markers of cachexia in metastatic lung cancer patients: Interrelations and associations with prognosis. Lung Cancer. 2011 Dec; 74(3): 516-520.

PubMed ID: 21632145
 
Study Design:
Diagnostic, Validity or Reliability Study
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To evaluate the correlation of the Mini Nutritional Assessment (MNA) with laboratory markers of inflammation or cachexia in patients with metastatic lung cancer. 

Inclusion Criteria:
  • 18 years and older
  • Histologically or cytologically newly diagnosed metastatic lung cancer.
Exclusion Criteria:
  • History of a second primary tumor except for non-melanoma skin cancer
  • Patients with chronic disease, concurrent infections and those who were on any medication that could interfere with the measured lab parameters were eligible but excluded form the particular lab data analysis. 
Description of Study Protocol:

Recruitment

Patients admitted to the Department of Medical Oncology for initiation of systemic chemotherapy. 

Design

Correlation of MNA with laboratory markers of inflammation or cachexia in patients with metastatic lung cancer and the prognostic value of the measured parameters.

Statistical Analysis

Pearson's Chi-Square, Spearman's correlation coefficient, independent samples T-test, Mann-Whitney U-test, one-way ANOVA, Kruskal-Wallis H-test. The Kaplan-Meier method was used to determine the effect of each categorical variable on survival and log-rank test to compare survival differences within each variable. For survival differences at the the uni-variate and multi-variate level the Cox proportional hazards model was used to estimate hazard ratios (HR) with 95% CI.

 

Data Collection Summary:

Timing of Measurements

Baseline (before radiation therapy or chemotherapy) and end of life.

Dependent Variables

  • MNA:
    • Score of more than 23.5: Nutritional adequacy
    • 17.0 to 23.5: Risk of malnutrition
    • Less than 17: Suggestive of malnutrition.
  • Lab:
    • Hb
    • Albumin
    • C-reactive protein
    • Total plasma ghrelin
    • Leptin
    • Adiponectin
    • IGF-I.

Independent Variables

  • Correlations between MNA and lab values
  • Prognostic role of these in overall survival.

 

Description of Actual Data Sample:
  • Initial N: 115 (101 males, 14 females)
  • Attrition (final N): 115
  • Age: 66 years ( range 32 to 86 years)
  • Location: Greece.
Summary of Results:

Findings

  • Median BMI (±SD) was 25.3kg/m2 (± 5.6) . 50 (43.5%) were overweight and 22 (19.1%) were obese at baseline. 
  • Per the MNA, 27 (23.5%) had adequate nutritional status while 59 (51.3%) were at nutritional risk and 29 (25.2%) were already malnourished at diagnosis
  • When MNA was considered as a continuous variable, it was significantly correlated with Hb (R=0.340, P≤0.001), albumin (R=0.470, P≤0.001), CRP  (R=-0.295, P≤0.001), adiponectin (R=-0.201, P≤0.006) and leptin  (R=0.399, P≤0.001)
  • Using uni-variate analysis, it was found that age (P=0.034), PS  (P=0.001), number of metastatic sites (P=0.001), MNA (P=0.004), albumin (P=0.001), CRP  (P=0.058) and leptin (P=0.005) were significantly associated with overall survival 
  • In multi-variate analysis, only age [HR=1.03 (95% CI: 1.01 to 1.05); P=0.008], the number of metastatic sites [HR=2.25 (95% CI: 1.49 to 3.40); P=0.001, MNA [HR=1.64 (95% CI: 1.01 to 2.66); P=0.044 and leptin  [HR=0.92 (95% CI: 0.87 to 0.97); P=0.004 were independent predictors of overall survival
  • Although baseline leptin levels were significantly different between obese and non-obese (P=≤0.001), there was no difference in survival (P≤0.104).
Author Conclusion:

Based on the MNA, the majority of patients were either malnourished or at nutritional risk. MNA correlated with laboratory parameters related to inflammation or cachexia and was independently associated with survival.

Funding Source:
Other: Cretan Association for Biomedical Research (CABR)
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? Yes
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? Yes
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? N/A
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes