EAL

ONC: Hematopoietic Cell Transplant (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the effect of TPN or PPN/EN on nutritional status of autologous HSCT recipients with solid tumors.

Inclusion Criteria:

Age 16 to 60 years of age
Confirmed malignant solid tumors
Karnofsky performance score above 60
Normal liver function
Creatinine clearance > 50ml/min
No signs of intractable cardiac failure
No tumor invasion of the bone marrow

Exclusion Criteria:

Not Specified

Description of Study Protocol:

Recruitment : Patients receiving autologous HSCT recipients with solid tumors were invited to join the study.

Design : Prospective Randomized controlled trial of total PN to a combination of PN with EN (see formulations below). Data was collected daily on weight, incidence of Diarrhea & Vomiting, Weight Height Index (WHI), and nitrogen/nutrient loss (urine collection or calculated creatinine clearance, vomit, stool). Data was collected less frequently on Lean Body Mass (calculated with Creatnine Height Index), BMR (calculated with Harris Benedict formula), Biochemical Indices (total protein, albumin, prealbumin, transferrin, IgG, IgM, IgA), Liver function (Alk Phos, LDH, SGOT, SGPT) , and Serum Biochemical Indices (Na, K, Cl, urea, creatinine, calcium, phosphorus, Mg, Zn, Cu).

Blinding used (if applicable): Not specified

Intervention (if applicable):

Group A:

TPN: 3400 non-protein kcal; 600g glucose, 100g fat, 148g protein, 4.0 L fluid
Total planned Nitrogen provision: 25g

Group B:

PPN/EN:
- PN: 1360 non-protein Kcal; 400g glucose, 74g protein
- EN: 2000 Kcal; 240g carbohydrate, 80g fat; 80g protein
- Total planned Nitrogen provision: 25g

Statistical Analysis :

T test
Sign test
Chi-square test
Yates correction were used
p<0.05

Data Collection Summary:

Timing of Measurements:

Daily:

Weight
Diarrhea & Vomiting
Weight Height Index (WHI)
Nitrogen/Nutrient loss (urine collection or calculated creatinine clearance, vomit, stool)

Baseline, days 7, 14, 21:

Lean Body Mass (calculated with Creatnine Height Index)
BMR (calculated with Harris Benedict formula)
Biochemical Indices (total protein, albumin, prealbumin, transferrin, IgG, IgM, IgA)
Liver function (Alk Phos, LDH, SGOT, SGPT)

Three times a week:

Serum Biochemical Indices (Na, K, Cl, urea, creatinine, calcium, phosphorus, Mg, Zn, Cu)

Dependent Variables

Duration of hospitalization
Morbidity
- Temperature
- Septicemia
Nutritional Status
- Nadir WHI
- Body weight
- Serum Albumin
- Serum Transferin
- Serum prealbumin
- Glucose
- Sodium
- Potasium
- Chlorine
- Magnesium
- Phosphorus
- Copper
- Zinc
- Calcium
- Nitrogen
- Leukocytes
- Thrombocytes
- CrCl

Description of Actual Data Sample:

Initial N: 22 (group A: 11; group B: 11)

Attrition (final N): 22 (group A: 11; group B: 11)

Age: Group A: 37.9 (range 28-54); Group B: 34.6 (range 21-56)

Ethnicity: Not specified

Other relevant demographics:

Cancer Diagnoses
	Group A (n=11)	Group B (n=11)
Small Cell Lung Cancer	2	3
Non-seminoma Testis	1	5
Breast Cancer	3	2
Ovarian Cancer	3	1
Gastric Cancer	1	0
Colon Cancer	1	0

Anthropometrics:

Baseline Anthropometric Characteristics
	Group A	Group B	Significance
WHI (%)	113.1±13.6	92.9±10.7*	p<0.001
CHI (%)	98.1±3.7	112.7±8.2*	p<0.001
Total Serum Protein (g/l)	63.7±5.8	63.7±6.6	NS
Serum Albumin (g/l)	41.2±4.5	40.2±4.1	NS
Transferrin (g/l)	2.6±0.6	2.2±0.5	NS
Prealbumin (g/l)	0.33±0.06	0.27±0.10	NS
BMR (kcal/d)	1550.7±216.7	1599.2±215.3	NS

Location: University Hospital, Groningen, Netherlands

Summary of Results:

Nutrition and Clinical Data
Variables	Group A	Group B	Statistical Significance of Group Difference
Hospital LOS	22.9 + 3.2 days	22.9 + 2.8 days	NS
Temperature > 38.5C	5.5 + 3.1 days	6.4 + 3.1 days	NS
Nadir WHI	110.1 + 13.6	90.7 + 11.7	p<0.001
Maxium decrease in BW	2.7 + 1.5	2.5 + 1.7	NS
Total Serum Protein (g/l)	50.1 + 2.3	50.1 + 3.1	NS
Serum Albumin (g/l)	29.2 + 2.2	27.8 + 2.0	NS
Serum Transferrin (g/l)	1.5 + 0.3	1.4 + 0.3	NS
Serum Pre-albumin (g/l)	0.17+0.04	0.16+0.06	NS
Hyperglycemia (n)	4	3	NS
Septicemia (n)	4	8	NS
Leukocyte < 1 x 10⁹/l	16.3 days	16.4 days	NS
Thrombocytes < 1x40⁹/l	14.2 days	13.9 days	NS
Sodium (mmol) Output as % intake	104.5+9.7	108.9+13.8	NS
Potassium (mmol) Output as % intake	80.7+8.8	85.7+9.7	NS
Chlorine (mmol) Output as % intake	95.7+5.2	94.2+12.5	NS
Magnesium (mmol) Output as % intake	111.9+91.8	98.7+60.6	NS
Phosphorus (mmol) Output as % intake	94.3+11.4	87.4+27.6	NS
Copper (mmol) Output as % intake	341+243	98.4+63.4	<0.01
Zinc (umol) Output as % intake	296+132	69.9+43.1	<0.0005
Calcium (mmol) Output as % intake	243+97	112.4+46.3	<0.0025
Nitrogen (mmol)	84.5+11.3	103.4+11.4	NS

No difference in days of vomiting

Significant decreased albumin, prealbumin, transferrin over time in both groups (no intergroup difference)

Significant decreased IgG, IgM, IgA over time in both groups (no intergroup difference)

No statistical difference in number of positive blood cultures or days of fever

Other Findings

No tube feeding related complications occured
Percentage of days with diarrhea lower in PPN/EN group
Higher N intake in Group A (1771.9±48.9 mmol/d) than Group B (1636.7±142.2 mmol/d) p<0.02
Half of patients in each group acheived positive nitrogen balance

Author Conclusion:

Both TPN and PPN with EN provide similar nutritional outcomes in patients with solid tumors receiving autologous HSCT.

Funding Source:

University/Hospital:

University Hospital Groningen (Netherlands)

Reviewer Comments:

No data presented on actual caloric intake
No information on adequacy of nutrient provision
No assessment of body composition to assess the impact of nitrogen balance on LBM

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?	No
	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.)	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?		???
	4.1.	Were follow-up methods described and the same for all groups?	???
	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
	4.4.	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
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?	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?	No
	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)?	???
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	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
9.	Are conclusions supported by results with biases and limitations taken into consideration?		N/A
	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?		No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes