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ONC: Hematopoietic Cell Transplant (2006)

Citation:
Skop A, Kolarzyk E, Skotnicki AB.  Importance of parenteral nutrition in patients undergoing hematopoietic stem cell transplantation in the autologous system.  Journal of Parenteral and Enteral Nutrition. 2005: 29(4), 241-247. PubMed ID: 15961679
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To assess the frequency of parenteral nutrition and to compare the impact of parenteral and oral feeding on the nutrition and clinical status of adults undergoing autologous hemopoietic stem cell transplantation. 
Inclusion Criteria:
  • All patients with neoplasm of the hemopoietic system
  • Underwent hemopoietic cell autotransplantation at the Hematology Clinic, Jagiellonian University, Krakow, Poland in the period 2001-2003
Exclusion Criteria:
  • Not Reported 
Description of Study Protocol:

Recruitment: All subjects undergoing HCT at at the Hematology Clinic, Jagiellonian University, Krakow, Poland in the period 2001-2003 were approached for consent. 

Design: Depending upon oral tolerance, assessed on a daily basis, patients were assigned to receive When parenteral nutrition (PN) (n=19, 54.3%) or oral nutrition (ON) (n=16, 45.7%). Daily requirements were estimated to be 25-30 Kcal/kg and 1.0-1.5g protein/kg.

Efficacy of nutrition intervention was evaluated on the basis of:

  • Clinical Condition
    • Respiratory efficiency
    • Circulatory system efficiency
  • Nitrogen balance
    • Using UUN based on 24-hour urine collections
    • N balance = nitrogen intake - (UUN + 4g/day)
  • Nutrition assessment (assessed pre-HCT, transplant day, day of granuolcyte recovery, discharge day)
    • Height
    • Weight
    • BMI
    • Biochemical indices (albumin, total protein)
    • Body composition (BIA)
  • Clinical status
    • Hematologic recovery (granulocyte >500/µL; leukocytes >1500/µL; platelets >20,000/µL)
    • Enzyme activity (ALT, AST, t-bilirubin)
    • Infections
    • LOS

 Blinding used (if applicable): Not applicable

Intervention (if applicable):

Nutritional needs were estimated at 25-30 Kcal/kg and 1.0-1.5g protein/kg. Five low bacterial meals were provided daily. If necesary oral intake was supplemented with 2-4 cartons of Nutridrink to provide 600-1200 kcal and 20-40g protein.

 PN was initiated if oral intake provided <50% of estimated requirements over 2 days however, oral nutrition was encouraged. PN was reduced over 1-2 days then discontinued, once oral intake exceeded 50% of 24-hour requirement. Caloric needs in PN patients were estimated using the Harris Benedict formula. PN provided 25-30 Kcal/kg and 1.0-1.5g protein/kg  in a total nutrient admixture (TNA) with:

  •  20-30% kcal from lipid
  • 15-25% kcal from amino acids
  • 50-55% kcal from glucose

Statistical Analysis

 The data ws non-normally distributet so nonparametric tests were used

  • Mann-Whitney test and Friedman test (nutrition and clinical status)
  • Descriptive statistics (LBM, body composition) 
  • p value <= 0.05
  • Statistics for Windows 6.0
Data Collection Summary:

Timing of Measurements

 Daily measurements:

  • Weight
  • Oral tolerance
  • Hematological indices
  • Infections

Three times a week:

  • Liver enzymes

Pre-HCT, transplant day, day of granuolcyte recovery, discharge day:

  • Clinical Condition
    • Respiratory efficiency
    • Circulatory system efficiency
  • Nitrogen balance
    • Using UUN based on 24-hour urine collections
    • N balance = nitrogen intake - (UUN + 4g/day)
  • Nutrition assessment
    • Height
    • Weight
    • BMI
    • Biochemical indices (albumin, total protein)
    • Body composition (BIA)

Dependent Variables

  • Variable 1: Clinical status as measured by:
    • Hematologic recovery (granulocyte >500/µL; leukocytes >1500/µL; platelets >20,000/µL)
    • Enzyme activity (ALT, AST, t-bilirubin)
    • Infections
    • LOS
  • Variable 2: Nutrition status as measured by:
    • Height
    • Weight
    • BMI
    • Biochemical indices (albumin, total protein)
    • Body composition (BIA)

Independent Variables

  •  Nutrient provision via PN
Description of Actual Data Sample:

Initial N: 35 (PN (n=19) 7 female, 12 male; ON (n=16) 12 female, 4 male)

Attrition (final N): 35 (PN (n=19) 7 female, 12 male; ON (n=16) 12 female, 4 male)

Age:

  • PN:  33.1 +/- 12.3 years
  • ON:  36.7 +/- 12.1 years

Ethnicity:

  • Not Specified

Other relevant demographics:

Diagnosis:

  • AML (n=7): PN n=3; ON n=4
  • ALL (n=2): PN n=2; ON n=0
  • Hodgkin's Ds (n=9): PN n=4; ON n=5
  • NHL (n=17): PN n=10; ON n=7

Anthropometrics

Baseline Body Composition Measurements
  Parenteral Group Oral Group
Women
Weight (kg) 61.5±13.7 70.6±18.1
Fat Mass (%) 24.9±11.7 32.2±7.0
LBM (%) 75.1±1.7 67.8±6.9
Body Water (%) 54.9±8.5 49.6±5.1
Men
Weight (kg) 77.3±13.7 85.3±14.6
Fat Mass (%) 20.1±10.7 23.5±5.9
LBM (%) 79.8±10.7 76.5±5.9
Body Water (%) 58.9±7.8 56.1±4.3

Baseline Nutrition Status
  Parenteral Group Oral Group
Women
Weight (kg)  69.4±15.6 74.3±18.1 
BMI  23.6±4.9 26.4±4.2 
Albumin (g/L)  41.6±4.8 41.6±3.3 
Total Protein (g/L)  68.9±7.8 68.0±6.9 

Location:

  • The Hematology Clinic of the Jagiellonian University Collegium Medicum in Krakow, Poland

 

Summary of Results:
  • PN required by 19 subjects (7 women, 12 men); 16 subjects (12 women, 4 men) fed orally
  • PN started (average) post-transplant day-5
  • PN contiuned 9.4 ± 2.8 days
  • Baseline Nutrition Status
    • No significant differences in BMI between groups at baseline
    • Lower fat mass, higher LBM and body water in PN group
  • Post-Transplant
    • Decrease in BMI, weight, and fat mass in both groups, no statistical difference between groups
    • Decrease in albumin in both groups, no statistical difference between groups

 

 
Parenteral Group
Oral Nutrition Group
Statistical Significance of Group Difference
Body Mass
Baseline
69.4±15.6
74.3±18.1
NS
Timepoint II
67.9±14.9
72.3 ±17.8
NS
Timepoint III
67.4±14.7
71.2±17.4
NS
Timepoint IV
64.9±14.3
70.2±17.5
p<0.05
BMI
Baseline
23.6±4.9
26.4±4.2
NS
Timepoint II
23.0±4.8
25.6±4.1
NS
Timepoint III
22.9±4.8
25.2±3.9
NS
Timepoint IV
22.0±4.6
24.9±4.1
NS
Albumin (g/L)
Baseline
41.6±4.8
41.6±3.3
NS
Timepoint II
39.1±4.1
39.9±3.5
NS
Timepoint III
37.5±5.6
38.8±3.9
NS
Timepoint IV
40.1±4.8
41.1±3.8
NS
Total Protein (g/L)
Baseline
68.9±7.8
68.0±6.9
NS
Timepoint II
63.4±6.8
65.3±6.8
NS
Timepoint III
64.0±8.1
65.1±6.3
NS
Timepoint IV
65.3±6.4
67.9±6.4
NS

 

Other Findings

  •  5 patients in the PN group continued oral intake at 3-5 Kcal/kg/day and 0.1-0.2g protein/kg/day
  • Pyrexia and infection more common in PN group, but not statistically significant 
Author Conclusion:

Parenteral nutrition supplying 25-30 Kcal/kg and 1.0-1.5g protein/kg maintained body mass and the functions of the hematopoietic system similar to oral and enteral feeding.

Funding Source:
Reviewer Comments:

The following limit the applicability of the article:

  • Small number of patients in each group
  • No discussion of actual nutrients consumed in comparison to needs
  • No assessment of the appropriateness of needs calculations
  • Data on 24-hour Nitrogen not presented 

 

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
  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
  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
  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
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
  1. Was the research question clearly stated? Yes
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.1. 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
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
  1.3. Were the target population and setting specified? Yes
  2. Was the selection of study subjects/patients free from bias? 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? No
  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? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
  3. Were study groups comparable? 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) No
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) No
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? 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
  3.3. 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
  3.4. 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
  3.5. 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
  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? No
4. Was method of handling withdrawals described? No
  4.1. Were follow-up methods described and the same for all groups? 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%.) No
  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%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? 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. 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
  5.1. 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
  5.2. 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
  5.3. 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
  5.4. 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
  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? No
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? No
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? 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
  6.2. 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
  6.3. 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? No
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? 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
  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. 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
  7.1. 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
  7.2. 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
  7.3. 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
  7.4. 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
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? 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. 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
  8.1. 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
  8.2. 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
  8.3. 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)? ???
  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)? ???
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  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? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
  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? No
9. Are conclusions supported by results with biases and limitations taken into consideration? No
  9.1. Is there a discussion of findings? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
  9.2. Are biases and study limitations identified and discussed? No
  10. Is bias due to study's funding or sponsorship unlikely? No
10. Is bias due to study's funding or sponsorship unlikely? No
  10.1. Were sources of funding and investigators' affiliations described? No
  10.1. Were sources of funding and investigators' affiliations described? No
  10.2. Was the study free from apparent conflict of interest? Yes
  10.2. Was the study free from apparent conflict of interest? Yes