EAL

ONC: Dietary Supplements and Medical Food Supplements Containing Fish Oil (2013)

Citation:

Weed HG, Ferguson ML, Gaff RL, Hustead DS, Nelson JL, Voss AC. Lean body mass gain in patients with head and neck squamous cell cancer treated perioperatively with a protein- and energy-dense nutritional supplement containing eicosapentaenoic acid. Head Neck. 2011 Jul; 33(7): 1,027-1,033. Epub 2010 Oct 21.

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To assess the safety and tolerance, as well as the pre-operative and post-operative impact of consumption of a specialized protein- and energy-dense, EPA-containing supplement on weight and body composition in adult patients with head and neck cancer-related weight loss undergoing treatment with curative intent.

Inclusion Criteria:

Diagnosis of squamous cell cancer of the head and neck: Stage II or greater or recurrent
Scheduled for surgical resection with curative intent
Loss of 5% or more of body weight during the preceding months
18 years of age and older
Karnofsky Performance Status of 70 or greater
Estimated survival time more than six months.

Exclusion Criteria:

Pregnant and lactating females
Second cancer (except skin carcinoma), uncontrollable diabetes, chronic renal failure, gastrointestinal disease that precluded adequate dietary intake, dementia, brain metastases, eating disorder or other psychological condition that might interfere with dietary intake
Severe nausea, vomiting or diarrhea
Clinically significant ascites, pleural effusion or edema
Radiation treatment to the head and neck area or chemotherapy within the previous two months
Currently taking medications, supplements or substances that could profoundly modulate metabolism or weight.

Description of Study Protocol:

Recruitment

Center patients meeting eligibility were consecutively selected.

Design

Prospective
Single-center
Open-label
Single-arm.

Intervention

Protein and energy dense EPA-containing oral supplement: Two containers per day (237ml per container) starting at trial entry and continuing until discharge from the hospital following surgery.

Statistical Analysis

Wilcoxon signed rank test.

Data Collection Summary:

Timing of Measurements

Baseline (two weeks before surgery), hospital admission, and hospital discharge (approximately 11 days after surgery) for body weight. Baseline and hospital discharge for body composition.

Dependent Variables

Body weight: Without shoes and with light clothing
Body composition: Bioelectrical impedance (Quadscan).

Independent Variables

Protein and energy dense EPA-containing oral supplement: two containers per day (237ml per container).

Control Variables

Usual diet.

Description of Actual Data Sample:

Initial N: 38
Attrition (final N): 31 (23 male, eight female)
Age: 62 years (37 to 79)
Ethnicity: White, 28; three not described
Other relevant demographics:
- Mean Karnofsky Performance status: 83
- Three subjects with stage II tumors, five had stage III, 22 had stage IV and five had a recurrent or a second primary squamous cell cancer of head and neck
- 28 smoked cigarettes at some time; four used smokeless tobacco. 16 were smoking at the time of trial
- Mean number of years of smoking was 36 years (range, 10 to 60 years). Mean number of cigarette packs smoked was 1.4 (range, 0.3 to 2.0 packs)
- 15 drank alcohol more than once per week, with eight having six or more alcoholic drinks per day more than once per week
Anthropometrics:
- Pre-illness weight: 72kg (range, 46kg to 113kg)
- Current weight: 63kg (range, 42kg to 97kg)
- Percentage weight loss before trial entry: 12% (range, 5% to 26%)
- Duration of weight loss: 4.2 months (range, one month to six months)
Location: Ohio and Australia.

Summary of Results:

Findings

Subjects consumed a mean of 1.8 containers per day of the supplement before hospital admission and 1.5 cans per day during hospitalization. 24 of the 31 subjects drank the supplement before hospital admission.
During the time subjects were consuming the supplement, 70% of the 27 for whom data were available maintained or gained total body weight from trial entry to time of admission and 57% of 30 subjects for whom data were available maintained or gained total body weight at the time of discharge. The mean weight gain was 0.71kg (N=27) from baseline to admission and 0.66kg (N=30) from baseline to discharge.
There was a statistically significant increase in lean body mass, (+3.20kg; +7%) from baseline to discharge (P<0.001, N=23) and a significant decrease in fat (-3.19kg).

Author Conclusion:

Patients with head and neck cancer can benefit from a protein and energy-dense, EPA-containing nutritional supplement before and after surgical treatment.

Funding Source:

Industry:

Abbott Laboratories

Pharmaceutical/Dietary Supplement Company:

Reviewer Comments:

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?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	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?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	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
	3.6.	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
	4.1.	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
	4.3.	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?	N/A
	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.)	N/A
	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
	5.5.	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?	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
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?	N/A
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)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	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