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it needs to excel — and shake up a Classic day!
Edward H.Gilbert, M.D., Denise Lindley
R.N.,BSN,OCN, Michelle Karlin, RN, AOCNP,FNP-BCNorthpoint Cancer Center,
Dallas Texas and Verity Cancer Center, Plano Texas
Radiation Induced Fatigue and a Nutritional Supplement Named
Radiation induced fatigue is a specific syndrome. It is much more defined
than “cancer related fatigue.” It is usually not multifactorial, and typically
arises within 1-5 weeks after the beginning of radiation treatments. There is
usually resolution in the 3-4 weeks post treatment. Radiation fatigue is less
intense than chemotherapy caused fatigue.
The nutritional supplement trial with Reliv was based on a number of
anecdotal stories of remarkable reversals in various symptoms, and in disease
processes such as arthritis, diabetes, fibromyalgia, etc. These responses
included reduced pain, increased energy, and feelings of wellbeing. This trial
had some degree of simplicity. The fatigue symptom was limited in etiological
causes, since the criteria for trial entry was fatigue presenting after the
start of radiation treatment. The response was to measure the change in a short
period of 1-4 weeks on the product. Patients were at different stages in their
radiation treatment. Many would be finishing, and in the 2-4 weeks after
completion fatigue normally improves on its own.
It was appreciated that this was essentially a “feasibility study,” and
its scientific accuracy would need to be documented in a controlled trial. Yet,
if any responses were seen, then this would validate doing a next phase. The
placebo effect itself was recognized as a limitation. Also, a major issue was
compliance in taking the powder twice a day, and thereby giving credibility to
any non-responders. This was not adequately measured, so that in the 9 patients
who had no response, lack of compliance was possible. However, the majority were
seemingly honest in their reporting.
Material and Methods:
The product used was Reliv Classic and for half of the study, Innergize
was added to the Classic Reliv. Availability of the product determined whether
Innergize was added. The dose was 1 scoop twice a day in liquid (it should be
noted that a minimum of 2 scoops twice a day is a more standard recommendation).
The lower dose was decided upon to help compliance. There was enough product
available for a 4 weeks trial for each patient.
The assessment tool was “The Fatigue Severity Scale.” It may not be
totally appropriate for radiation caused fatigue, but it was at least a rough
validation of response. Absolute scores were less important than relative change
of the score over time. Compliance of returning the questionnaire was very
varied, but all had at least 2 responses. The attempt was for 1 response a week.
Further, patients were interviewed as to how they perceived their responses to
be. For this study, credibility was given to the patient subjective
Patient selection was their declaration of significant fatigue, starting
after the onset of radiation treatment. There was no restriction on when the
fatigue began and when they started on the Reliv.
It should be noted that there were no other variables introduced to the
patients. The fatigue began, and rather than giving any further interventions,
the Reliv was started. Further, the acute results are what are being reported.
Still, as noted in the individual reports, there were some patients with longer
lasting effects, with these patients willing to continue the supplement on their
Excellent response was a combination of significant change in the
“Fatigue Severity Scale” and their self reporting of a major improvement. A good
response was from a +8 to +15 change and also the self report of good
improvement. No response could be their stopping the product (one because of
vomiting), compliance problems, and most frequently the report of no response
and no score improvement.
Radiation induced fatigue is a well defined symptom linked to radiation
therapy. There has not been an adequate treatment approach, with little having a
significant effect. Physical exercise is considered very important, but patients
are often too tired to have a consistent regimen. Mind-body therapies can be
helpful, but most patients do not pursue these (acupuncture, meditation, message
therapies, etc). And there are the issues of a more pronounced “cancer related
fatigue,” complex in etiology and suggested intervention techniques. Further,
many of these patients are on concurrent chemotherapy, are anemic, and report
other cancer treatment related side effects.
Nutritional recommendations are controversial and very complicated. A
general statement of taking vitamin supplements, or extra specific minerals, or
various therapies such as juicing, is often made. Patients are typically left to
their own pursuits or discoveries, yet most health care professionals would
encourage nutritional approaches to help the fatigue problem. Using a product
such as Reliv, with a 22 year history, was a relatively simplistic attempt to
study whether a response was possible.
This study was a “feasibility study” in the sense that all we were
looking for was some effect. The number of variables to do a proper scientific
analysis is large, and would represent the next phase of research. The
possibility of the placebo effect requires a randomized trial, and was
inappropriate to this feasibility study. However, this is recognized in
reporting, as well as compliance difficulties, and subjectivity of the
questionnaires. All that said, there were the very definite improvements, and in
some situations, dramatic changes.
Reliv contains a variety of vitamins, minerals and herbs in a powder base
excellent for absorption. It is an easy product to prescribe, with dosing fairly
standard. Further, there has been much experience with some studies and many
testimonials for a positive result with Reliv. We personally were encouraged by
these reports of significant improvement with a range of symptoms from other
diseases. Testing a nutritional supplement for relief from fatigue was the
motivation for this study. Further, few nutritional products have been formally
recommended by the scientific experts in oncology.
The result was a certainly positive response. Approximately 75% of the
patients with radiation fatigue had relatively immediate results, many within 2
weeks of starting the product. Roughly 25% of the cohort reported excellent
results in reversal of radiation fatigue, and improvement or relief from other
symptoms. There was no harm done to those who reported no response (except one
with a few episodes of vomiting). The results warrant a more extensive trial
with all the scientific rigors applied.
Reliv is distributed through a multilevel sales channel. Some clinicians and
administrators have high resistance and negative preconceptions of products
distributed via multilevel marketing. It is crucial to point out that all
product in this study was provided free of charge and no attempt was made to
enlist patients in further purchase or marketing the product. A few members of
the cohort did buy additional product after the initial response but none were
asked to participate in distribution.
Cancer related symptoms often are the most significant issue in quality
of life. Treatments such as radiation can be highly symptom producing, with
fatigue perhaps the most generic problem. Having the possibility to reverse this
problem during the course of radiation is a significant benefit helping both the
patient, their family, and the healthcare professionals managing their
A feasibility study on 37 patients undergoing or just having completed
radiation and having significant radiation fatigue was conducted. The patients
were placed on a nutritional supplement program named Reliv, and measured for
response over 2-4 week continuous treatment. Results show that 75% of
participants considered their result as helping their fatigue, and 25% of the
entire group reported an “excellent” response. The feasibility study’s result
warrants a second phase clinical study conducted under rigorous scientific
methodology, and should be considered for the syndrome of “cancer related