EAL

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

Citation:

Piquet MA, Ozsahin M, Larpin I, Zouhair A, Coti P, Monney M, Monnier P, Mirimanoff RO, Roulet M. Early nutritional intervention in oropharyngeal cancer patients undergoing radiotherapy. Support Care Cancer. 2002 Sep; 10(6): 502-504. Epub 2002 Aug 2.

PubMed ID: 12353130

Study Design:

Non-Randomized Controlled Trial

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To assess the effects of an early and systematic nutritional intervention, including PEG insertion, in patients undergoing radiation therapy for oropharyngeal carcinoma.

Inclusion Criteria:

All Subjects: Outpatients with oropharyngeal cancer who were undergoing radiation therapy with total doses of 66 to 70 Gy in six to seven weeks
Control group: Patients with oropharyngeal carcinoma paired for age and TNM staging who had been treated with radiation therapy between 1995 and 1997.

Exclusion Criteria:

None indicated.

Description of Study Protocol:

Recruitment

Outpatients of Centre Hospitalier Universitaire Vaudois undergoing radiation therapy for oropharyngeal cancer were recruited.

Design

Non-randomized control trial.

Intervention

Prospective nutritionist assessment and care at least three times during therapy for all patients
PEG nutrition support with polymeric diet including fiber; PEG provided for individuals with weight loss of 10% of their usual weight or BMI less than 20kg/m² or age older than 70 years
NGT nutrition support with polymeric diet including fiber; NGT was placed in case of severe dysphagia with dehydration
Patients without PEG or NGT received dietary counseling and high-calorie supplements by mouth.
All interventions were calorically calculated at 30kcal per kg of usual weight

Statistical Analysis

The statistical analysis is done with an ANOVA or the non-paired Student T-test for quantitative variables and a Chi-square test for qualitative variables.

Data Collection Summary:

Timing of Measurements

Week one: Baseline nutrition assessment
During Study: Compliance to nutritionist follow-up, NGT necessity, PEG-related complications and changes in condition
Week six or seven: Weight loss and hospital admission endpoint measures collected.

Dependent Variables

Weight
Hospital admission
Nutrition/hydration status.

Independent Variables

Nutrition support: Counseling and enteral nutrition via PO, PEG or NGT.

Control Variables

Age
Gender
Weight
Radiation therapy
Nutrition Interventions.

Description of Actual Data Sample:

Characteristics	Intervention Group (N=45)*	Control Group (N=45)*
Age (years)	61±1.5	59±1.5
Sex ratio (M/F)	43/2	42/3
Weight before radiation therapy (kg)	69±2	68±3
Nutrition support
Early PEG	33/45 (74%)	5/45 (11%)
Late NGT	6/45 (13%)	12/45 (27%)
No tube feeding	6/45 (13%)	28/45 (62%)

*Subjects N accounts for initial and final count of subjects.

Location

Lausanne, Switzerland.

Summary of Results:

Key Findings

Variables	Intervention Group (N=45)	Control Group (N=45)	Statistical Significance of Group Difference
Weight loss (%)	3.5±0.7	6.1±0.7	P<0.01
Overall hospital admissions	9 (20%)	14 (31%)	NS
Hospital admission for dehydration	0 (0%)	8 (18%)	P<0.01
Death due to dehydration	0 (0%)	2 (4.4%)	NS

Author Conclusion:

This study allows us to propose criteria for PEG insertion in patients undergoing radiation therapy for head and neck cancer. In our opinion, PEG should be systematically performed before radiotherapy in the case of recent weight loss of more than 10% of the usual weight or a BMI less than 20kg/m² or aged older than 70 years.
In conclusion, early nutritional intervention reduces weight loss in patients with oropharyngeal cancer who are undergoing radiation therapy. It is important to set up early nutritional support to prevent impairment of performance status and dehydration, which is life threatening in older patients. Insertion of a PEG before radiation may improve patients' quality of life by decreasing the frequency of hospital admissions.

Funding Source:

University/Hospital:

Centre Hospitalier Universitaire Vaudois

Reviewer Comments:

Author indicates in the conclusion that patients are alcoholics; the study does not give any further indication of comorbidities or pathophysiology of oropharyngeal cancer. This may be a confounding factor that is not considered in analysis.
Hydration status appears to be a concern in the study but measures of IV fluids or free water flush per PEG enteral feedings were not taken into consideration
Conditions resulting in hospitalizations were not considered, nor were the treatments performed during hospitalization
Other therapies such as rehabilitation, alimentary, pharamcologic and home alternative therapies were not mentioned
Statistical significance of PEG vs. nutrition counseling and supplementation were not calculated to validate conclusion of PEG protocol implementation during oropharyngeal treatment
No reference was provided for criteria used to identify malnutrition. Malnutrition criteria is not a validated tool or diagnostic protocol.

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?		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?	???
	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?	No
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)	No
	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.)	No
	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.)	???
	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
	4.1.	Were follow-up methods described and the same for all groups?	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
	4.4.	Were reasons for withdrawals similar across groups?	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
	5.1.	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?	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
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) 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
	6.8.	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?	???
	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
	7.7.	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)?	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?	Yes
	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
	9.1.	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?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes