EAL

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

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine whether nutritional status (measured as body weight) has an effect on the quality of life for patients with acute leukemia undergoing polychemotherapy.

Inclusion Criteria:

•Undesired weight loss of more than 5% of the original body weight within 3 months before cytostatic treatment

•And/or actual weight below 90% ideal body weight

•Between 17- 60 years

•Planned therapy according to regimens LAM-6 without m-AMSA-application, TAD-9, Ulm-protocol:subgroups LAM, TAD, ULM

Exclusion Criteria:

•Metabolic diseases

•Renal or liver insufficiency

•Need for artificial nutrition

Description of Study Protocol:

Recruitment : All acute leukemia patients admitted consecutively to medical departments I and II of Cologne University between 1986 and 1988 for induction treatment of acute lymphocytic or nonlymphocyctic leukemia.

Design: Before starting chemotherapy, patients were randomised to receive either intensified oral nutrition plus dietary intervention (group B) or ad libitum nutritional intake(group A).

Blinding used (if applicable) Not disclosed

Intervention:

Dietetic intervention:
- Daily visit by a registered dietitian to assess:
  - Nutritional status and nutrition behavior
  - Calculation of nutrient requirements
  - Composition of menu and diet modification if necessary
  - Need for nutrition education for patients and relatives
  - Daily nutrient intake
  - Daily patient motivation
  - Therapy-side effects
  - Doctor's information on drug treatment for emesis
  - Oral mucostitis
  - Diarrhea
  - Patient's subjective well-being
  - Menu composition for out-patient phases

Statistical Analysis

Differences between the groups and subgroups were tested to be significant at a level of P<0.05 using the Wilcoxons Mann-Whitney U test
Statistical evaluation of subjective well-being was restricted to the patients under LAM and UL protocols due to the significantly differing outcomes of patients in the TAD groups
Correlation between quality of life and nutritional parameters were calculated only for periods of complete hospitalization (induction treatment) in order to standardize the patients' social surroundings
Principal factor analysis was calculated with the help of the SPSS-program using the following steps:
- Z-transformation of the LASA-values (mean:0, SD:1)
- Generation of a factor matrix using principal factors
- Varimax rotation of principal factors
Correlations between LASA-items or principal factors of subjective well-being and energy intake or changes of body weight are described by Spearman's rank correlation coefficients
For testing the coefficients' statistical significance the two-tailed Student's t-test was used for: n>30; and for n<30 the Ferguson-test

Data Collection Summary:

Timing of Measurements

Daily measurements:
- Assessment of nutritional status and nutrition behavior
- Calculation of nutrient requirements
- Composition of menu and diet modification
- Nutrition education for patients and relatives
- Assessement of nutrient intake
- Patient motivation
- Assessment of therapy-side effects
- Doctor's information on drug treatment for emesis
- Oral mucositis
- Diarrhea
- Assessment of patient's subjective well-being
- Menu composition for out-patient phases
Weekly:
- Body weight changes
- Calculation of the non-protein energy intake (group B only)
- Self-assessment of well-being on linear analogue scales using standardized questionnaires with 16 questions, characterizing the typical complaints of leukaemic subjects during tumour-therapy ( group B only)
During last week of study:
- I was not (rated 0) I was very intensively (rated 10) suffering from:
  - Weakness, helplessness, sorrow, unrest, anxiety hopelessness, anorexia, nausea, amesis, pain, taste disturbances, stomatitis
- My quality of life, my health, my physical feeling...was not (rated 0)/was very intensively (rated 10) impaired.

Dependent Variables

Nutritional status (group A & B)
Nutrient intake (group B)
Evaluation of subjective well-being (group B)

Independent Variables

Dietetic intervention

Control Variables

Menus of free choice with a daily offer of:
- 1. 1.0-2.0g protein
- 2. 30-50kcal IBW
Protein/kcals dependent on patients' pretreatment nutritional status
- <90% ideal body weight:2g protein/50kcal
- <110%: 1.4g/35kcal; >120%: 1 g/30 kcal)

Description of Actual Data Sample:

Initial N: 31

Attrition (final N): 29 (2 died within 4 weeks after entering study)

Age: Range 21-52 years old

Ethnicity: Undisclosed

Treatment:
LAM-A   3 females/3 males
LAM-B   4 females/3 males
TAD-A   1 female/4 males
TAD-B   2 females/1 male

TREATMENT

Acute lymphocytic leukemia patients:

Ulm-A 3 females/2 males
Ulm-B 3 females/3 males

* 3 patients were treated with 2 complete induction courses of LAM-6 + Ulm protocal.

Anthropometrics: Could not determine

Location: Cologne, Germany

Summary of Results:

1st cyctostatic drug treatment	Nutrition status of group A &B decreased	Nutrient intake of group A & B decreased
During treatment	Group A mean weight loss of 49% per week	Group B weight loss of 2.6% per week
	11 out of 16 patients in group A showed body weight below 95% of prestudy weight	5 out of 16 patients in group B showed body weight below 95% of prestudy weight
	31.3% of group A had regained their initial nutritional status	68.6% of group B had regained their initial nutritional status

Other Findings

The amount of spontaneous oral nutrition is diminished during those periods in which patients suffer most intensively from the side-effects of tumour therapy
The inadequate nutrient intake is followed by loss of body weight with delay (as a consequence of this time lag, the correlation coefficient between energy intake and course of body weight is rather low: r=0.49)
During periods of intensive weight loss, patients primarily mention the subjective feeling of fatigue/malaise

Author Conclusion:

1. Life threatening malnutrition was prevented in all of our patients even during the stress of antileukaemic treatment by dietetic intervention, without artificial nutrition. That is why this group of patients may not routinely be nourished by artifical access.

2. Daily applied dietetics is superior to standard hospital feeding with respect to the nutritional status of leukaemic patients.

3. Intensive oral nutrition therapy with continuous dietetic counselling and motivation is an effective adjunct to aggressive antitumor therapy -not only with respect to the nutritional status, but also to patients' quality of life.

Funding Source:

Reviewer Comments:

•small study size

•tables and figures were confusing - where did they find the information for the tables and figures

•statistical results seem to be missing

•too much unnecessary information that made the results difficult to interpret

•references to "hospital food" which was not part of this study

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?	???
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?	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
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	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?	???
3.	Were study groups comparable?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	???
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	???
	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?	Yes
4.	Was method of handling withdrawals described?		Yes
	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%.)	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
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	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
	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?	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?	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?	No
7.	Were outcomes clearly defined and the measurements valid and reliable?		No
	7.1.	Were primary and secondary endpoints described and relevant to the question?	No
	7.1.	Were primary and secondary endpoints described and relevant to the question?	No
	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?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	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?	???
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	???
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	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)?	No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	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?	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?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes