EAL

ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To verify the modification of the caloric and protein ingestion according to three types of nutritional intervention in patients with head and neck cancer undergoing radiotherapy.

Inclusion Criteria:

Head and neck cancer patients that were submitted to exclusive complementary radiotherapy in the postoperative period of surgery.
Signed the document of free and informed consent.

Exclusion Criteria:

Life expectancy less than 2 months
Previous or current malignant neoplasms of other organs
Malabsorption syndrome
Hepatic or renal insufficiency
Abandonment of the treatment

Description of Study Protocol:

Recruitment 64 patients with head and neck cancer that were submitted to exclusive complementary radiotherapy in the postoperative period of surgery. The patients were distributed into 3 groups based on current oral intae:

1) oral group-- 32 patients
2) feeding tube group -- 16 patients
3) supplement group -- 16 patients.

Design Prospective non-randomized study of oral intake with nutrition counseling versus oral intake with liquid nutritional supplement versus enteral nutrition All patients were counseled by the nutrition staff. Patients with intake >75% of estimated needs (40Kcal/Kg, 1.5g protein/kg) were placed in the oral intake group. Those who's intake was < 75% esdtimated needs were placed in the group that had took the supplemental liquid nutritional supplement. Patients with oral intake <66% of estimated needs were placed in the EN group. Weight, anthropometrics and serum laboratires were collected at baseline and follow-up. The time to follow-up is not specified.

Blinding used None

Intervention

All patients were required to prepare their diets at home. They were provided with printed diet instructions, and were given dietary instruction during an initial consultation.

Oral Group After tertiary alimentary anamnesis and individualized dietary orientation, the oral diet of each patient was adapted during the nutritional attendance period according to their individual needs
- Consistency was adapted for a pureed diet if needed
- Diet was fractioned into 5-6 meals/day if needed
Feeding Tube Group The enteral diet was administered via nasoenteral feeding tubes with gastric placement when acceptance of oral alimentary diet was less than 2/3 of the nutritional recommendations.
Supplement Group The oral diet was associated with alimentary supplement consisting of a powdered enteral diet to be reconstituted whenever the acceptance of oral diet was less than 75% of the nutritional recommendations.

Statistical Analysis Kruskal-Wallis test was applied for the variables of age, height, duration of nutritional therapy and radiotherapy, as well as for recommended proteins and calories.

Data Collection Summary:

Timing of Measurements

Evaluation of the nutritional state was carried out in the initial and final nutritional consultation.

Dependent Variables

Caloric intake
Protein intake
Weight
Anthropometric measures

Independent Variables

oral diet
enteral feeding
nutrition supplements

Control Variables

Teletherapy with a mean total dose of 6000 + 1414 gy (5000 to 7000) and a daily dose rate from 180 to 200 gy.

Description of Actual Data Sample:

Initial N: 64 patients

Attrition (final N): 64 patients

Age: Mean age = 62 + 1.5 years

Ethnicity: not indicated

Other relevant demographics: not indicated

Anthropometrics

Obtained height, body weight, tricep skinfold, midarm circumference and muscle area -- None of these measurements was reported.
Obtained lab values of serum albumin, total protein, total lymphocyte count, hematocrit, and hemoglobin -- none of these measurements was reported.

Location: Radiotherapy Clinic of the Department of Nutrition and Dietetics of the Institute of Radiology, Clinicas Hospital, University of Sao Paulo Medical School

Summary of Results:

	Oral group	Feeding tube group	Supplement group
Calories (kcal) pre	1310 + 781	911 + 753	1659.3 + 745.7
Calories (kcal) post	1589 + 582	1907 + 507	1751.9 + 542.0
% calories pre	55 + 32	43.2 + 29.9	78.6 + 34.9
% calories post	66 + 24	90.1 + 27.5	84.5 + 26.6
Protein (g) pre	51.1 + 30.4	35.1 + 23.5	63.6 + 34.9
Protein (g) post	70.5 + 28.8	77.0 + 21.7	76.6 + 27.4
% protein pre	56.6 + 34.5	41.5 + 28.0	75.5 + 44.8
% protein post	77.8 + 30.0	91.9 + 29.0	106.0 + 47.5

The caloric ingestion increased in all 3 groups (p<0.001), as shown in the table above.
In relationship to energy needs, a better adaption was seen in the supply of calories following the nutrition intervention (p<0.001)
The greatest differential between pre- and post-nutrition intervention values occurred in the feeding tube group for both calories and protein (p<0.05).
There was a significant increase in protein ingestion by all three groups (p<0.001).

Other Findings

The 3 groups did not present differences in relation to age and height, duration of nutritional therapy and radiotherapy.
The anthropometric indicators did not demonstrate a significant difference in the 3 groups during treatment with maintenance of the initial values.
There were no differences in the 3 groups between the serum values of albumin, total protein, hematocrit and hemoglobin, with the exception of total lymphocytes, the values which decreased significantly in all 3 groups following radiotherapy.

Author Conclusion:

The authors concluded that specialized nutritional intervention in patients with head and neck cancer undergoing radiotherapy can increase their caloric and protein intake and maintain anthropometric and laboratory measurements. They suggest that nutrition evaluation and counseling are appropriate for head and neck cancer patients receiving radiotherapy to prevent deterioration in nutritional status.

Funding Source:

Other:

no funding reported

Reviewer Comments:

No description of time between data points

Cannot determine length of treatment and therefore the appropriateness of the lenght of intervention

Data on weight and anthropometrics not presented

There was no control group which did not receive nutrition intervention; however, ethical considerations would preclude this.

Because patients prepared their own diets at home, it is difficult to evaluate compliance with dietary instruction.

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?	N/A
2.	Was the selection of study subjects/patients free from bias?		N/A
	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?	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?	???
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)	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?	???
	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.)	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?	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?	Yes
	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?	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	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?	???
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	???
	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?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	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?	???
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	???
	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?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	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?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	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?	???
10.	Is bias due to study's funding or sponsorship unlikely?		???
	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