EAL

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

Citation:

Correia M, Cravo M, Marques-Vidal P, Grimble R, Dias-Pereira A, Faias S, Nobre-Leitão C. Serum concentrations of TNF-alpha as a surrogate marker for malnutrition and worse quality of life in patients with gastric cancer. Clin Nutr. 2007 Dec; 26(6): 728-735.

PubMed ID: 17949861

Study Design:

Diagnostic, Validity or Reliability Study

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To examine, in patients with gastric cancer, the correlation between nutritional status, QOL (quality of life) and serum levels of TNF-alpha, IL-1, and IL-6.

Inclusion Criteria:

Diagnosis within four weeks of gastric cancer
Consecutive admission to gastroenterology unit.

Exclusion Criteria:

Artificial nutrition, major surgery, radiotherapy or chemotherapy in the year prior to assessment
Chronic and cachetizing condition other than gastric cancer.

Description of Study Protocol:

Recruitment

All those meeting the criteria who gave informed consent.

Design

Determine which of the cytokines, IL-1, IL-6 and TNF-alpha is more implicated in cancer cachexia of patients with gastric cancer.

Statistical Analysis

Categorical data were expressed as number of patients and (percentage): Continuous data were expressed mean ±SD and range. Comparisons were made using χ² test, Student's T-test or non-parametric tests. Concordance analysis was performed using Kappa coefficient. Spearman non-parametric correlations were used to assess relations.

Data Collection Summary:

Timing of Measurements

Within one week of being admitted to the hospital, before any therapeutic intervention.

Dependent Variables

Nutritional status: Percentage of weight loss (severe if more than 10% in previous six months or more than 5% in past month) and Ottery's PG-SGA (well-nourished, mild malnutrition (MN) or severe MN)
Body composition: Bioelectrical impedance categorized by fat free mass index (FFMI) and fat mass index (FMI)
Functional assessment: Hand grip dynamometer on non-dominant hand using the average of three measurements with a grip strength less than 85% of age and sex-adjusted reference considered as markers of protein depletion and MN
QOL assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ).

Independent Variables

Serum TNF-alpha, IL-1 and IL-6 concentrations.

Description of Actual Data Sample:

Initial N: 48 (36 males, 12 female)
Attrition (final N): Same
Age: 69±12 years
Location: Lisbon, Portugal.

Summary of Results:

Other Findings

24 (50.0%) lost more than 10% body weight over the previous six months and 36 (75%) had lost more than 5% in the immediate past month. Per the PG-SGA, 89.6% were MN with 31.2% being mild MN and 43.8% being severely MN. The final score on the PG-SGA indicated a need for some type of nutritional intervention for 89.2% of the patients (12.5% dietary counseling only, 25% oral nutritional supplements and 25% artificial nutrition).
All patients were above the normal for FMI. The FFMI was low in 29.4% of the women and 27.3% of the men. No significant associations were found between FFMI depletion and dynamometer with and stage of disease. Hand grip dynamometry values were below the 85 percentile in 52% of the the patients.
Concordance analysis showed that PG-SGA was the only method that was simultaneously correlated to percentage weight loss in one month (k=0.697), FFMI (k=0.547) and dynamometry (k=0.874)
Gender, age and tumor type did not influence any of the EORTC-QLQ scales. Patients with more advanced disease or tumors in the antrum had significantly worse global QOL of the functional scale (P<0.05 and P<0.001, respectively). A worse QOL was positively associated with dynamometry, percent of weight loss at one month, FFMI and MN identified by PG-SGA. The PG-SGA was the only method in which malnourished patients had worse performance in all dimensions of QOL questionnaire. Anorexia and pain were the symptoms more often and consistently associated to worse QOL.
Mean values for IL-1 was 14.4±13.7pg per ml, for IL-6 5.6±3.6pg per ml and TNF-alpha 22.3±13.9pg per ml. A significant and direct association was observed between the serum levels of all three cytokines. Patients harboring diffuse type carcinomas had significantly higher values for IL-1, as compared to patients with intestinal type tumors (23.8±4.7 vs. 12.1±2.8pg per ml, P<0.05). No significant differences were observed for the other cytokines. Association with stage of disease was not found for any of the three cytokines.
Malnourished patients had significantly higher values of IL-1 and TNF-alpha, but no differences were found in IL-6 values. When using the PG-SGA to identify MN patients, a significant correlation was found with all three cytokines. The TNF-alpha values showed an excellent discriminative power to identify MN patients with a sensitivity of 93% and a specificity of 94%.
TNF-alpha was the more significantly associated to worse QOL in both functional and symptom scales and also to anorexia. Patients with anorexia had TNF-alpha serum values of 28.4pg per ml vs. the non-anorectic patients having values of 11.3pg per ml, P<0.001.
No significant associations were observed between nutritional status and the occurrence of perioperative complications. It was noted that of the 21 patients classified as severely MN by PG-SGA, only five were offered surgery because the remainder had either advanced disease or poor general condition.

Author Conclusion:

The prevalence of MN is high in patients with gastric cancer. A significant correlation was found between higher values of cytokines, especially TNF-alpha, MN and QOL.

Funding Source:

University/Hospital:

Intituto Portugues de Oncologia Francisco Gentil, Lisbon, Portugal

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?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	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")?	N/A
4.	Was method of handling withdrawals described?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	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?	N/A
	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?	N/A
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?	N/A
	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?	Yes
	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)?	N/A
	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