EAL

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

Citation:

Block KI, Gyllenhaal C, Tripathy D, Freels S, Mead MN, Block PB, Steinmann WC, Newman RA, Shoham J. Survival impact of integrative cancer care in advanced metastatic breast cancer. Breast J. 2009 Jul-Aug; 15 (4): 357-366. Epub 2009 May 12

PubMed ID: 19470134

Study Design:

Case Study or Case Series

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

The purpose of this study was to report the outcomes and prognostic variables for patients with metastatic breast cancer (MBC) attending a community-based facility (the Block Center for Integrative Cancer Treatment) (BCICT) which integrates conventional cancer therapies with individualized nutritional biotherapy, nutraceutical support, fitness and physical care programs and mind-spirit strategies.

Inclusion Criteria:

All advanced MBC patients diagnosed before 1998 who received chemotherapy under the BCICT's supervision
All consecutive cases of advanced MBC presenting during the study period were included in the study.

Exclusion Criteria:

None

Description of Study Protocol:

Recruitment

Patients were recruited from the BCICT. All consecutive cases of advanced MBC presenting during the study period were included in the study.

Design

Survival time from onset of distant or systemic metastasis through 2002 was determined form patient's hospital and medical records, and confirmed through consultation with the National Death Index and other records in publicly accessible databases.

Blinding used

None

Intervention

Oncologists developed a personalized nutrition and supplement regimen. The registered dietitian educated patients and provided hands-on training.

Nutritional assessments included anthropometrics, individual caloric needs or weight gain or loss, and markers of nutritional, oxidative, immune, inflammatory status. The diet emphasized intake of whole grains, fruits and vegetables with low glycemic indices, plants, fish, dairy alternatives and egg whites as the protein source. Supplements taken by all patients in the study included fish oil, a multivitamin-mineral supplement designed for cancer patients, a mushroom-based immune supplement and a phytochemically-rich vegetable and fruit drink; other supplements frequently used included mixed carotenoids, melatonin, calcium-D-glucarate, reishi mushrooms and green tea. Patients received intravenous vitamin infusions during chemotherapy which included vitamins A,C,D,E,K,B-vitamins, calcium, magnesium, and trace minerals, in all doses slightly under to a few times higher than the Recommended Daily Allowances.

Statistical Analysis

A Kaplan-Meier survival curve was generated from the time of diagnosis of metastatic disease. Median survival time and corresponding 95% confidence intervals were computed. The log rank test was used to compare survival distributions between different predictor variable states, and Cox proportional hazards modeling was used to assess contributions of different variables to survival outcomes.

Data Collection Summary:

Timing of Measurements

Measurements were taken at entry to the study (in 1998) and then at the close of the study (2002).

Dependent Variables

Variable 1: Prognostic factors (lymph node, estrogen receptor status, tumor size)
Variable 2: Metastasis (onset and location)
Variable 3: Survival time from onset of distant or systemic metastasis.

Independent Variables

Treatment received at BCICT

Control Variables

Advanced metastatic breast cancer

Description of Actual Data Sample:

Initial N: 90
Attrition (final N): 90
Age: Age at metastasis
- ≤40: 16
- 41-50: 46
- >50: 28
Ethnicity:
- European: 81
- African: 5
- Asian: 2
- Hispanic: 2
Other relevant demographics: Patients had an average of 1.8 previous chemotherapy treatment regimens before presenting at the BCICT (range zero to four); 15 patients had undergone unsuccessful high-dose chemotherapy with bone marrow transplant. Other than two patients, all received their adjuvant chemotherapy at other centers, prior to developing progressive disease and seeking treatment at the BCICT.
Anthropometrics: Not Applicable
Location: Chicago, IL.

Summary of Results:

Key Findings

Median survival time from metastasis was 38 months (range seven to 137 months, 95% CI 27-48)
The three-year survival was 52%, the five-year survival was 27%
Disease free interval <18 months, age group (<40, 41-50, >50) and estrogen receptor status (positive or negative) significantly predict survival
Disease-free interval of more than 18 months had a significantly longer survival than those with a shorter disease-free interval (log-rank test, Chi Squared=7.2, df=2, P=0.007.

Author Conclusion:

Five-year survival was 27% for the BCICT vs. 17% for comparison patients. Despite a higher proportion of younger and relapsed patients, the survival of MBC patients at the BCICT was approximately double that of comparison populations and possibly even higher compared to trials published during this period.

Funding Source:

University/Hospital:

University of Illinois at Chicago, Chicago IL, University of Texas Southwestern Medical Center, Dallas, TX, Tulane University Health Sciences Center, New Orleans, LA, University of Texas MD Anderson Cancer Center, Houston, TX, Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel,

Not-for-profit

KaMaH, the Israel Center for Health Promoting Therapies, Gimzo, Isreal

Other non-profit:

Reviewer Comments:

Descriptive study of survival after metastatic breast cancer diagnosis. Survival rate was much higher than other centers. Difficult to determine cause and effect. Did not discuss compliance, other treatment regimens.

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?	???
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
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.)	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?	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
	3.6.	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?		N/A
	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?		N/A
	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.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
	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?		???
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	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?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	???
	6.6.	Were extra or unplanned treatments described?	???
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	???
	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?	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)?	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?	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes