Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.
But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’
The website of the manufacturer provides the following information on IP:
Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.
- Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
- Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
- Observe the recommended daily serving of the product. This product should not be given to infants or children.
The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.
I cannot say that this inspires me with confidence.
What about the trial itself?
To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.
9 Responses to Cancer fatigue: is a dietary supplement the answer?
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I must say that I feel a tad angry. Those who participated in this trial probably did so in the hope of adding to the knowledge about possible treatments for CRF, while the bad design of this study excluded any possibility of gaining any insight from the beginning. They have effectively spent their very valuable and most probably severely limited time on an effort that was doomed to have no impact at all from the start.
Unlike for acupuncture or similar treatments, it should not have been a problem at all to properly control for placebo effects in this trial, but not even an attempt seems to have been made. The suspicion that this design was chosen for a reason that had nothing to do with proper scientific conduct seems not too far-fetched. If this suspicion did reflect reality, the participants of the study and their willingness to participate would have been abused.
Cancer and the side-effects of the illness itself and its (effective) treatment – most specifically, but not only CRF – are not a laughing matter and not a place for quacks or money-makers, trying to earn a profit off the plight of others without giving anything in return but misplaced hope.
thanks
no research is a laughing matter; this is why the ‘A+B versus B’ design is so devious in my view.
They needed a placebo … a pouch of something that looks and tastes like the IP, and woth all of it in a blank pouch.
And I’ve found that HOW you ask the questions – body language and tone of voice – can change answers on subjective pain surveys. All interviews should be done by a TAPED interviewer so all participants see and hear the same things.
the investigators need to be blinded as well.
This reminds of the study on the effects of an extract of cat’s claw (Uncaria tomentosa) on cancer-related fatigue conducted in Brazil:
http://www.ncbi.nlm.nih.gov/pubmed/25495394
Although I have yet to read the study in full, I suspect that the excuse for the absence of a placebo control in such studies is argued on the basis of ethics. There are numerous examples of those from China.
You said “excuse”, and that is what I would probably call it, but in all honesty, I would like to hear that ethical argument and how it would preclude a study design of the form “Standard Care plus Placebo” vs. “Standard Care plus Verum”.
@Lighthorse
I read the abstract twice and I can find no indication of this being a study.
The paper is conveniently hidden behind a pay per view wall.
This is not science, this is most likely material produced for fraudulent marketing. It is published in a journal that seems to be run to make money of publishing fake science.
The purported “study” is not a trial, only an observation of only 51 seriously ill cancer patients who all received an herbal remedy. There was no control so this cannot be considered science. A number of simple explanations can be listed why the patient’s QOL increased as measured by some questionnaires during the observation period.
What do you think precluded this being conducted properly as a scientific study? Apart of course from the need to produce something resembling a scientific article to cite in advertisements for the product.
Yes, you are quite right: without so much as a control group, no one can call this objective science, or claim that the extract improved QOL, although you can bet that someone will. Later, after I acquire the paper, I will take a close look to see what if any reason they gave for not including appropriate controls and post again.
no good reason given