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

Citation:

Hyltander A, Bosaeus I, Svedlund J, Liedman B, Hugosson I, Wallengren O, Olsson U, Johnsson E, Kostic S, Henningsson A, Körner U, Lundell L, Lundholm K. Supportive nutrition on recovery of metabolism, nutritional state, health-related quality of life, and exercise capacity after major surgery: A randomized study. Clin Gastroenterol Hepatol. 2005 May; 3(5): 466-474.

PubMed ID: 15880316
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To follow up on their previous short-term kinetic studies of metabolism and resumption of oral eating after major surgery. They aimed to investigate whether long-term specialized EN and PN supportive feeding during convalescence has superior effects on recovery of nutritional state, physical functioning and health-related quality of life (HrQoL) post-operatively, leading to different outcome in patients with pre-operative weight loss and reduced physical functioning.

Inclusion Criteria:

Patients with major resective surgical procedures in the upper gastrointestinal tract with final acceptance to randomization and follow-up when RO (curative) resection for patients with malignant disease was deemed possible in patients judged to be co-operable to comply with the protocol.

Exclusion Criteria:
  • Impaired renal or hepatic function
  • Disseminated malignant disease
  • Ongoing corticosteroid treatment.
Description of Study Protocol:

Recruitment

Patients referred to the Department of Surgery at Sahlgrenska University Hospital for resection of the esophagus, stomach or pancreas. 

Design

Randomized control.

Intervention

Patients receiving EN or PN post-operatively at home.

Statistical Analysis

Statistics are mean ± standard error of mean (SEM). Survival was calculated by Kaplan-Meier analysis and tested by the log-rank technique. Time course changes were compared between and within groups over time by analysis of variance (ANOVA) for repeated measures. The frequency of complications was tested by chi-square analysis. P<0.05 was considered significant. Statistical power of analysis with α=0.05 and β=0.80 implied a need for less than 95 patients provided 10% to 15% improvements in a primary variable. 

Data Collection Summary:

Timing of Measurements

One, three, six and 12 months post-operatively.

Dependent Variables

  • Nutritional state: Body weight, height, triceps skin fold and arm muscle circumference
  • Body composition: Lean body mass and body fat were measured by dual-energy x-ray absorptiometry
  • Blood tests: Blood hemoglobin, serum albumin, bilirubin, alkaline phosphatase, alanine aminotransferase, aspartase aminotransferase, creatinine and total urinary nitrogen
  • Indirect calorimetry: Resting energy expenditure was measured by indirect calorimetry in the morning during resting conditions after an overnight fast. Exercise capacity was measured by walking on a treadmill.
  • Dietary Intake: Patients completed four-day dietary record at home one, three, six and 12 months post-operatively (including two weekend days); all food and beverage were recorded in household measures and preparation procedures were noted. Used the nutrient database of the Swedish National Food Composition Tables. Dietary records were validated by measurements of total urinary nitrogen.
  • Health-related quality of life: Subjective physical, mental and social disease and treatment consequences were evaluated with the following self-administered questionnaires:
    • Eating Dysfunction Scale
    • Gastrointestinal Symptom Rating Scale
    • Psychological General Well-Being Index (PGWBI)
    • Comprehensive Psychopathological Rating Scale
    • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC_QLQ-C30).

Independent Variables

  • Oral diet
  • Enteral nutrition
  • Parenteral nutrition.
Description of Actual Data Sample:
  • Initial N: 126 patients (82 male and 44 female)
  • Attrition (final N): 126 patients
  • Age: Mean age 63±4 years
  • Other relevant demographics: Esophagus resection (N=48), stomach resection (N=28) and pancreas resection (N=50)
  • Anthropometrics: There were no significant differences among groups in any anthropometric, biochemical or clinical measures
  • Location: Sweden at the Sahlgrenska University Hospital.
Summary of Results:

Key Findings

Patient Groups and Complications

  • 46 patients (36%) considered for the study were never included as a result of disseminated disease disclosed at laparotomy, because curative resection was impossible to achieve; thus, 80 patients were included for follow-up. However, after introduction of pre-operative endoscopic ultrasound examination together with explorative laparoscopy, all prospective patients were possible to include.
  • 43% of all patients had pre-operative weight loss more than 10% without difference among the groups
  • There was no significant difference in the composition of the feeds among the groups over time or within groups over time
  • Survival did not differ significantly among the groups as well as mean hospital stay
  • 10 patients on EN and PN discontinued nutritional treatment within one month. Of these, seven were patients with feeding jejunostomies lost during the night, stuck in clothes during daytime or ceased to function during the study time. Three patients experienced pain and discomfort receiving EN and therefore refused further treatment. Eight patients on PN had replaced central venous catheters one or several times or refused to participate because of complications of technical origin. Two patients were not motivated to continue treatment because of subjective well-being and good appetite.
  • Infection with fever, septicemia and pneumonia were significantly more common in the PN group compared to the EN and oral group (P<0.01)
  • Sepsis occurred only in the PN group (P<0.01)
  • Gastrointesteinal symptoms of diarrhea, pain and discomfort were most common in the EN group (P<0.01)
  • There was no difference between the EN and PN groups in complication rate unrelated to EN or PN feeding
  • The oral group had significantly lower overall complications
  • Mean duration on artificial nutrition was on average 51±38 days in the EN group and 55±36 days in the PN group, with a range of one to 105 days and one to 120 days, respectively.

Resting Energy Expenditure, Energy and Protein Intake

  • Resting energy expenditures were the same before operation and during follow-up among the groups
  • No significant difference was seen in total energy and protein intake between the groups over time
  • The oral group had significantly lower total energy intake at one month post-operatively
  • Mean artificial intake was 429±97kcal per day (EN, N=12) and 407±96kcal per day (PN, N=11) calculated for all patients one month after operation and 120±66kcal per day (EN, N=3) and 148±70kcal per day (PN, N=4) at three months post-operatively.

Body Composition

  • Triceps skinfold was significantly higher in the PN group at one and three months post-operatively compared to the EN and oral groups
  • Body weight and body fat decrease (P<0.05) over time to a similar extent in all groups without any difference among the groups over time
  • Lean body mass did not change over time within groups measured at six and 12 months post-operatively.

Biochemical Tests, Respiratory Gas Exchanges and Exercise Capacity

  • Albumin concentrations increased within groups over time in all groups (P<0.05)
  • Insulin-like growth factor I showed trends to decrease over time within the EN and PN groups (P<0.05 to 0.10)
  • Serum bilirubin decrease over time within all groups in a similar way (P<0.05).

Health-Related Quality of Life

  • Significant differences in outcomes were revealed after six months among the groups
  • Diarrhea (according to EORTC QLQ-C30) was significantly more pronounced in the EN groups than in the PN or oral groups after six months (P<0.01)
  • The psychological general well-being improved more in the PN group than in the EN and oral groups post-operatively
  • The difference in the PGWBI total emerged from six months onward after the operation (P<0.05)
  • The PGWBI dimensions of anxiety and positive well-being followed the same pattern with less anxiety and more positive well-being in the PN group (P<0.05)
  • Emotional functioning according to EORTC QLQ-C30 had improved significantly more in the PN group compared to the oral group after six months (P<0.01), but after 12 months the groups were not significantly different.  
Author Conclusion:

Post-operatively, little benefit is realized from intensive nutrition support as either EN or PN when normal gut function is expected to return soon. Post-operative EN or PN are not superior to oral intake guided by a dietitian, and EN and PN are more likely to cause harm. PN should be reserved for patients who cannot eat.

 

Funding Source:
University/Hospital: Medical faculty at Goteborg University
Not-for-profit
Swedish Cancer Society
Other: Swedish Research Council, Assar Gabrielsson Foundation, Jublleunskllnlken Foundation, IngaBritt & Arne Lundberg Research Foundation, Swedish and Goteborg Medical Societies
Reviewer Comments:

No limitations mentioned throughout the manuscript.

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? ???
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.) Yes
  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? Yes
  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? 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.) 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? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  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? Yes
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  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? 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)? Yes
  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? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? ???
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
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