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

Citation:

 Bauer JD, Capra S. Nutrition intervention improves outcomes in patients with cancer cachexia receiving chemotherapy-a pilot study. Support Care Cancer. 2005; 13: 270-274.

 
Study Design:
Non-Controlled Trial
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To assess the effect of an oral nutrition supplement and nutrition counseling on dietary intake, nutritional status, body composition, functional status and quality of life in patients with cancer cachexia receiving chemotherapy.

Inclusion Criteria:
  • Weight loss more than 5% during the previous six months
  • Life expectancy more than two months
  • Karnofsky performance status (KPS) more than 60
  • Pancreatic or non-small cell lung cancer.
Exclusion Criteria:
  • Medications potentially affecting metabolism such as steroids
  • Use of fish oil capsules.
Description of Study Protocol:

Design

Non-controlled trial.

Intervention

  • Weekly counseling with RD
  • Consumption of nutrition supplement minimum of one time per day
    • 1,298kJ (310 calories), 16g protein, 1.1g eicosapentanoic acid (EPA)
  • All subjects received chemotherapy (gemcitabine alone or in combination with another agent).

Statistical Analysis

  • Magnitude of differences: Friedman's test
  • Change in lean body mass (LBM): Wilcoxon signed rank test
  • Change in nutritional status: Chi square
  • Association between nutritional status and change in quality of life, KPS and LBM: Correlation analysis
  • Statistical significance is P<0.05.

 

Data Collection Summary:

Timing of Measurements

  Baseline Daily Week Four Week Eight
Dietary intake x   x x
Nutritional status x   x x
KPS x   x x
LBM x   x x
Quality of life x   x x
Consumption of supplement   x    

Dependent Variables

  • Dietary intake
    • Three-day food record
    • Weight
  • Nutritional status
    • Subjective global assessment (SGA)
    • Patient-generated SGA
  • Karnofsky performance status
  • Lean body mass: Total body water assessed with stable isotope deuterium and assumed hydration constant
  • Quality of life: European Organization for Research and Treatment of Cancer Quality of Life questionnaire.

Independent Variables

Consumption of nutritional supplement.

Description of Actual Data Sample:

Initial N

Eight.

Attrition (final N)

  • Seven (Five male, two female)
  • Deterioration in clinical status between enrollment and baseline: One.

Age

55.1±5.0 (mean±SD).

Other Relevant Demographics

  • Pancreatic cancer: Five
  • Lung cancer: Two.

Anthropometrics 

BMI: 26.8±5.7.

Location

Australia.

Summary of Results:

Key Findings

Variables

Baseline

Median (Range)

Week Eight

Median (Range)

P Value

Energy intake (kJ per kg per day)

108 (53 to 120)

25.8kcal per kg (12.7 to 28.7)

140 (105 to 175)

33.4 kcal per kg (25.1 to 41.8)

 0.011

Protein intake (g per kg per day)

 1.1 (0.6 to 1.4)

1.4 (1.2 to 2.0)

 0.011
PG-SGA score 13 (4.0 to 19.0)

4.0 (1.0 to 16.0)

 0.019
KPS 80 (60 to 90) 90 (80 to 100) 0.01
Quality of life 66.7 (33.3 to 91.7) 83.3 (66.7 to 100) 0.019
  • Over eight weeks there was non-significant median increase in weight of 2.3kg (range -2.7 to 4.5)
  • Over eight weeks, there was a non-significant median change in LBM of 4.4kg (-4.4 to 4.7)
  • At baseline, five patients were classified as moderately malnourished per SGA; after eight weeks one patient was classified as malnourished (P=0.057). None were classified as severely malnourished at baseline or at the end of eight weeks.
  • Over eight weeks, change in nutritional status, determined by PG-SGA score, was significantly associated with change in LBM (R=-0.998, P=-0.040), change in KPS (R=-0.879, P=0.009) and change in quality of life (R=-0.835, P=0.020).

Other Findings

  • Median EPA intake of supplement was 1.06g (range 0.63 to 2.17g) at week eight
  • Compliance with supplement: Plasma phospholipid EPA was significantly increased at eight weeks (median of 5.71%, range 0.35 to 9.57%) compared to baseline (median of 0.84%, range 0.31 to 1.17%), P=0.015
  • Oral supplement did not affect dietary intake at meal time.

 

Author Conclusion:

Along with chemotherapy, nutrition counseling and use of an oral nutritional supplement resulted in improvements in nutritional status, Karnofsky performance status, lean body mass and quality of life in patients with non-small cell lung or pancreatic cancer.

Funding Source:
Industry:
Ross (Abbott Laboratories) supplied supplement
Pharmaceutical/Dietary Supplement Company:
University/Hospital: The Wesley Research Institute
Reviewer Comments:
  • Small sample size
  • Unclear whether improvement in variables due to nutrition counseling; increase in calories, protein or EPA; effects of chemotherapy or a combination of all
  • Not clear how many times subjects met with RD during the eight weeks
  • Not clear how many cans of supplement patients consumed on a daily basis.
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? ???
  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? No
  2.2. Were criteria applied equally to all study groups? N/A
  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? ???
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.) No
  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? 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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  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.) No
  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? No
  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? 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? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? N/A
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)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  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? No
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