• Stage II-IV breast CA
• Female
• Receiving HCT
• Well nourished upon admission for HCT (> or = 90% IBW or UBW, absence of recent wt loss or poor oral intake, serum albumin > or = 30 g/dL);

There was no statement of how many were excluded.

• Did not meet well nourished criteria at admission to study

Recruitment:  No statement of how recruiting was done, or who did the recruiting 

Design: Randomized clinical trial with subjects randomized to either OD or TPN; no mention as to how the randomization was done

Blinding used (if applicable):  No mention of blinding

Intervention:

• Kcal need was determined using Harris-Benedict equation and protein need was set at 1.5 - 1.75 g/kg b wt; used adjusted body wt if "significantly" over IBW
• OD group:  Standard iv fluids of either 5% dextrose or normal saline; given TPN if oral intake fell below 40% of need for 10 consecutive days, wt loss of 10% of admission wt, need for mechanical ventilation.
• TPN group:  TPN started day before HCT (day -1); also give iv fluids; TPN was 3-in-1 admisture (final concentration17.5% dex, 5% aa, 10% lipid) 3 times/wk and other 4 days 2-in-1 formula (25% dextrose, 5% aa, final concentration); vitamins and minerals added daily
• Both groups allowed to eat ad libitum
• TPN discontinued when oral intake > or = to 50% of nutrient need for 2 consecutive days

Statistical Analysis: 

• Intent-to-treat principles applied
• T-test evaluated differences between groups
  • Age
  • Days to engraftment
  • LOS
  • Days on antibiotics
  • Days of fever
  • Body wt changes
  • Days on TPN
  • Number of days until oral intake >66% of need
  • Nutrient intake
• Repeated measures analysis of variance  
  • Changesin triceps skinfold
  • Midarm muscle circumference
  • Serum albumin
  • Total bilirubin
  • LFTs
  • HGS
  • Sense of well-being
• Survival analysis using Kaplan-Meier plots
• No mention of level of significance used

Timing of Measurements: 

• Pt characteristics at baseline
• Clinical outcomes -- not stated when measured
• Nutrition outcomes measured at admission to +30 days post tx
• Sense of well-being was measured admission, discharge (no day mentiond so assume variable) and +30 days post tx
• Survival was > or = to 1 year post tx.

 Dependent Variables

• Variable 1: LOS - days in hospital from initial hospitalization 
• Variable 2: Days to engraftment (not stated how measured) (ANC > 500)
• Variable 3:  Incidence of infection determined by positive blood culture
• Variable 4:  Days on antibiotics - not stated how measured
• Variable 5: days of fever  - > or = 100.5 F
• Variable 6:  changes in total bilirubin - not stated how measured
• Variable 7: liver function tests - not stated how measured
• Variable 8:  calorie intake - not stated how measured
• Variable 9: protein intake - not stated how measured
• Variable 10: number of days until oral intake met 66% of nutrient needs
• Variable 11: body wt - not stated how measured
• Variable 12: handgrip strength - not stated how measured
• Variable 13: triceps skinfold - not stated how measured
• Variable 14: midarm muscle circumference - not stated how measured
• Variable 15: serum albumin - not stated how measured
• Variable 16: days on TPN - not stated how measured
• Variable 17: sense of well-being measured using the Profile of Mood States (POMS); no info about realiability or validity
• Variable 18: survival for 1 year or more post treatment
• Variable 19: nutrition status - intact vs depleted

Overall poorly defined variables with little information how how measured or how operationalized.

Independent Variables:  Assigned to oral intake only (OD) or TPN only.  Also created a third group of pt who were randomized to the OD and ultimately placed on TPN and called the delayed TPN (DTPN) group

Control Variables: Age, stage of disease, source of HCT (marrow or peripheral blood), number of pt given TPN

Initial N: 55 females

Attrition (final N):  55 females; no attrition info addressed in the article

Age: 42 y for TPN and 46 y for OD; no info on DTPN group

Ethnicity: no info provided

Other relevant demographics: breast cancer stage TPN = 13 in stage II and III; 14 in stage IV.  OD group 10 in stage II and III; 18 in stage IV.

Source of transplant - TPN = 3 peripheral and 24 marrow; OD = 4 peripheral and 24 marrow

no stats done from what I can tell

Anthropometrics: admission TPN wt = 68 kg          OD wt = 76 kg

                                               TPN TSF  = 29 mm       OD TSF = 32 mm

                                               TPN MAMC = 21 cm      OD MAMC = 24 cm

                                               TPN HGS = 58              OD HGS = 66

                                                TPN Alb = 31 g/L       OD Alb = 32 g/L

Location:

While prophylactice TPN preserved nutritional status and possibly QOL better than OD, there were no differences found in clinical outcomes or survival.

Prophylactic TPN did result in a more intact nutritional status (no stats) and preservation of lean body mass in TPN but did not impact LOS or survival.

Not much difference and very little information as to how exactly the measures/variables were operationalized. Cox proportional hazard model may have provided better statistical analysis than measures used

Harris-Benedict equation used to determine energy needs

Adjusted body weight was used to determine energy needs if "significantly" over IBW; however, "significantly" is not defined

Cox regression analysis not used

No info on how operationalized nutrient intake; not the best stats for this b/c of differing times by subject

Level of statistical significance not mentioned