EAL

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

Citation:

Guarcello M, Riso S, Buosi R, d’Andrea F. EPA-enriched oral nutritional support in patients with lung cancer: Effects on nutritional status and quality of life. Nutr Ther Metab. 2007; 25: 25-30.

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate in lung cancer patients undergoing chemotherapy, the effects on nutritional status and quality of life of the administration of an EPA-enriched oral supplement.

Inclusion Criteria:

Provided written informed consent
Histologically proven diagnosis of lung cancer and eligible for chemotherapy
Presence of malnutrition as established by a body weight loss more than 10% vs. usual weight in the previous six months
Performance status according to Karnofsky more than 60
Life expectancy more than two months.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Patients were recruited from the oncology unit of Maggiore Hospital of Novara, Novara, Italy.

Design

Randomized controlled trial.

Statistical Analysis

Data are presented as medians and interquartile ranges
Intergroup comparability was determined by the chi-square test and the Mann-Whitney test
Data obtained at T0 were compared with those at T1 and T2 (per protocol analysis) using the Wilcoxon test for nonparametric data
P<0.05 were considered statistically significant.

Data Collection Summary:

Timing of Measurements

Anthropometric and biochemical indices as well as appetite, energy and protein intake, and performance status were evaluated at enrollment (T0), after 30 days (T1), and after 60 days (T2)
Acute phase proteins such as C-reactive protein (CRP), transferrin, albumin and prealbumin levels were determined by nephelometry
Circulating TNF alpha, IL-1 and IL-6 levels were measured by immunometric methods using chemiluminescence
Anthropometric indices included height (m), weight (kg) and body weight loss vs. usual body weight as recalled by the patient, triceps skinfold and midarm muscle circumference
Daily energy and protein intakes were calculated based on the dietary diaries of three consecutive days (two work days, one non-work day). Patients were instructed by dietitians on how to fill them out.
Data on food intake reported by diaries were then translated into energy and protein intakes by means of specific tables validated for Italian foods
Patients were also requested how many cans of the supplement they took daily
Appetite was self-assessed by patients at the study time points via a 100mm non-weighted visual analogue scale (zero equals lack of appetite, 100 equals hunger)
Performance status according to Karnofsky was evaluated at T0, T1 and T2 in every patient.

Dependent Variables

Nutritional status and quality of life: Evaluated at enrollment (T0), after 30 days (T1) and after 60 days (T2) in all patients. Quality of life was measured via the self-administered EORTC QLQ-C30 questionnaire. It is specific for cancer patients and investigates the domains of global health status (GHS), functional status (FS) and symptom scale (SS).

Independent Variables

Study group: Patients randomized to this group were required to supplement their usual oral diet with two cans a day of an EPA-enriched, energy-dense oral supplement (ProSure, Abbott) which provided 590kcal and 32g of protein per dose
Control group: Patients randomized to this group were required to supplement their oral diet with two cans a day of an energy-dense, non-EPA enriched supplement, which provided 550kcal and 30g of protein per dose (P=NS).

Description of Actual Data Sample:

Initial N: 46 (26 in the study group, 20 in the control group)
Attrition (final N): 25 (14 in the study group, 11 in the control group)
Age:
- Study group mean age: 65.6 years (43 years to 79 years, range)
- Control group mean age: 68.7 years (51 years to 79 years, range).
Other relevant demographics:
- Three in the study group had a diagnosis of small cell lung carcinoma (SCLC) and two in the control group had a diagnosis of SCLC
- 23 in the study group had a diagnosis of non-small cell lung carcinoma (NSCLC) and 18 in the control group had NSCLC.
Anthropometrics:
- Mean body mass index (kg/m²):
  - Study group: 22.2 (16 to 27.8)
  - Control group 24.9 (22 to 27.4)
Location: Maggiore Hospital of Novara, Novara, Italy.

Summary of Results:

Key Findings

Patients in the study group showed significant increases in body weight (57.7kg at T0 vs. 58.6kg at T30, P<0.05), energy intake (1,300kcal per day at T0 vs. 1,780kcal per day at T30 and 2,000kcal per day at T60, P<0.05) and protein intake (40g per day at T0 vs. 56g per day at T30 and 60g per day at T60).
Patients in the study group also showed significant increases in appetite (four at T0 vs. six at T30, P<0.05) and quality of life (64.4 at T0 vs. 82.2 at T30 and 77.7 at T60, P<0.05)
Patients in the study group also showed significant increases in prealbumin (21.1 at T0 vs. 24.1 at T30, P<0.05), transferrin (169 at T0 vs. 194 at T30, P<0.05) and C-reactive protein (1.8 at T0 vs. 0.6 at T30 and 0.5 at T60, P<0.05).

Author Conclusion:

The present study shows that an EPA-enriched energy-dense oral supplement may positively influence relevant clinical endpoints in lung cancer patients receiving chemotherapy.

Funding Source:

Other:

Abbott Laboratories

Reviewer Comments:

The authors noted that there was a high dropout percentage and it could be useful to carry out further studies with a better selection of patients suitable for treatment and a different assessment of results by intention to treat.

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?	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?	No
3.	Were study groups comparable?		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?	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?	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?	Yes
	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?	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?	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
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?	N/A
	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?	No
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