A group of 29 patients,
all with stages 3-4 neoplastic diseases or various localizations, declared
refractory to conventional oncological therapeutic procedures, were submitted
to a 16 week, inpatient regime which consisted of the administration of
a 100% pure shark cartilage preparate either rectally (first six weeks)
or orally (thereafter) on dose ranges that went from I to 2.26 g. per 2
pounds of body weight. Patient's response to the product's administration
was monitored regularly in clinical humoral and imagenological terms. A
total of 15 patients did show benefit from shark cartilage administration
based upon body weight gain, rising levels of hemoglobin and hematocrite,
better performance of the cell-mediated immune response pattern and Karnofsky's
index as compared to the pre- admittance patterns. Tumor size reduction
ranged from 15 to 67% in prostatic cancers and
12 to 25% in ovarian cancers. Also, no regrowth of surgically removed CNS
tumors was detected. No secondary or adverse product related reactions
were observed in more that 15,000 administered doses, except for two skin
reactions. Interesting histopathological features consisting mainly of
a peculiar behavior of the connective tissue developing fibrosis, in metastasis
lymph nodes and other organs of the decreased patients (6) in whom an autopsy
was performed, are also mentioned. Authors emphasize thatshark cartilage
administration, although demanding a more thorough research, seems to be
valuable in the treatment of advanced cancer disease in whom conventional
therapeutic approaches have demonstrated to be of no further help.
INTRODUCTION
Today options for the treatment
of advanced cancer disease, (ACD) are sometimes held back by the tonic
or -unwanted effects of the majority of the therapeutic agents. These agents,
although technologically very sophisticated, are really of scarce value
in some selected patients.
Bone marrow failure, various grades
of kidney dysfunction, cardiocirculatory disturbances and also incipient
sips of radiotoxemic disease are becoming the main yielding factors to
complete scheduled cycles of radio and chemotherapy. Also, surgery sometimes
is of limited value, as tumors are not able to benefit from surgical removal
very frequently.
'Therefore, it seems logical to
consider, for further development or therapeutic schemes in ACD, the testing
of another family of oncospecific agents that are supposed to accomplish
the main therapeutic goal of being able to exhibit standard oncological
properties without being harmful to the patient already battered immune
system
from the progression of neoplastic disease and by the toxic and secondary
effects of the employed therapy.
The use of animal cartilage for
various therapeutic purposes can't be considered a new item. In fact, various
attempts have been made during the last 15-20 years to establish it's therapeutic
usefulness in cancer treatment.
Although interesting enough to deserve
more careful attention from the medical community, administration of shark
cartilage seems to have reached a certain and critical point of development.
Some kind of decision has to be made in order to assess the real effectiveness
of this non-toxic therapeutic approach for the treatment of ACD.
PATIENTS
AND METHODS
An open-labeled highly selective
prospective biomedical experiment was designed and performed by a multidisciplinary
medical team on a medical facility in Havana, Cuba, on 29 patients who
voluntarily agreed (written consent) to take part in a 16 week inpatient
regime therapeutic trial.
The main goal was responsiveness
to the administration of shark cartilage on clinical humoral and imagenological
terms, and also the surveillance for the identification and characterization
of secondary and/or adverse reactions related to the product's administration.
Clinical workup during the biomedical experience consisted of daily medical
rounds, weekly staff meetings, and evaluations which were held at the 16th
week.
The administered product consisted
of unadulterated 100% pure dry shark cartilage. It's chemical analysis
disclosed the following composition: 4 1 % ash ( 60% composed by calcium
and phosphorus at a 2:1 ratio); 39% protein, 12% carbohydrates, 7% water,
less than 1% fiber and less than 1% fat. Shark cartilage was administered
rectally through a 15 g (50 n3l enema) plastic syringe. After each dose,
the patient was instructed to lie in a right
decubitus for 25 to 30 minutes. After the sixth week, patients were free
to continue in the rectal administration route or to take the product orally
using 1g coated capsules swallowed with natural juices.
Standard dose was I g per each 2
pounds of body weight as a rule. Well-documented medical criteria could
change dose to a higher extent never to a lower one. No life- expectancy
criteria was taken into consideration for the inclusion of patients in
the study.
RESULTS
Mean age group was 67.4 years. Age
ranges were 17 to 82. Sex distribution was practically equal (5 1% females
and 49% males). The most represented age group was the one that ranged
from 57 to 67 years. White predominated over blacks.
Benefit from shark cartilage administration
was assessed using an integral criteria that included humoral discriminating
values, assessment of Karnofsky's index scores before and after treatment
and also imagenological evidence obtained throughout the whole experience.
The group of patients (15) who did
benefit from the product's administration had hemoglobin values remain
practically unchanged. The same thing happened with the hematocrite values.
Eritorosedimentation rates increased at 64% of their initial values by
the 16th week. Mean body weight of the group was 64.17 kg.
The immunological serum pattern
was found to be in the following parameters:
Increase of 2.14% of the pre-treatment
values of the Active Rosette Test (ART), with the values of the Spontaneous
Rosette (SRT) being 15.08%. Levels
of circulating immunocomplexes were 237% and serum medium con3plement activity
(CH-50) was found to be increased by 2.14%.
An overall decrease of serum immunoglobulins
did
take place. IgA descended down to 8.83%, IgM to 50.50% and IgG to 10.8
1%, as compared to the initial determinations.
Of the group of patients in whom
a beneficial effect of shark cartilage was not demonstrated (14), the following
humoral values were found: hemoglobin levels decreased by 13%, hematocrit
levels by 9% and eritrosedimentation rates by 50% ( initial ESR were somewhat
higher in this group.)
ART and SRT showed increases of
3.76% and 15.08% respectively, while levels of circulating immunocomplexes
increased up to 241%of their initial values and medium serum complement
activity was less than I% (exactly 0. 59%).
Also, a decrease of circulating
immunoglobulins took place; IgA-8.47%, Igm.-24.87% and IgG in 18.9%.
Karnofsky's index behavior was not
uniform Among the 29 patients submitted to the medical experience, a total
of 16 improved or maintained their initial scores. A total of 5 patients,
although worsening at the end of the experience, improved their scores
for a short period of time. A total of 8 patients steadily decreased in
score. It is noticeable that in one series a total of 4 patients scored
100 points at the end of the 16 week period (normal life with no disease-related
sips and symptoms).
Brain tumors scored a 60% improvement
of Karnofsky's index behavior. Two patients with brain tumors had to be
operated upon on behalf of uncontrolled intracraneal hypertension. One
patient from the brain tumor group scored I 00 points at the end of the
16 week period (normal life with no disease-related signs and symptoms).
Brain tumors scored a 60% improvement
of Karnofsky's index behavior. Two patients with brain tumors had to be
operated upon on behalf of uncontrolled intracraneal hypertension.
One patient from the brain tumor group scored 100 points.
Among prostatic tumors, 4 out of
5 patients improved their initial Kaniofsky's index , scores.
One patient, though showing a progressive trend in improving
initial
score,
died from an intra-abdominal infectious condition
not tumor-related
in
the early post-operative period.
In breast tumors, 4 out of
6 patients improved or maintained their initial scores. Among the two breast
cancer patients that died, early Karnofsky scores improved.
The two patients with ovarian cancers had increasingly
higher Karnofsky indexes throughout the trial. In one patient, a dramatic
improvement of her clinical condition progressively took place that allowed
her to be classified from a patient that demanded considerable help and
frequent medical care to one who leads a normal life with minor sips and
symptoms of malignant disease. The other patient had considerable tumor
reduction, allowing her to be re-operated upon. The surgical procedure
was success&l this time. The tumor that had been formerly attached
to the pelvic wall (frozen pelvis) was removed in a practically bloodless
operation.
Among the two patients with uterine malignant
conditions, an improvement of Karnofsky's index score were attained. However,
one of the two patients died from an acute myocardial infarction.
Among the two patients with malignant liver conditions,
the one with a primary hepatocarcinoma maintained normal He-style pattern
with minor signs and symptoms of the disease during the entire 16 week
period. The other patient with metastastic liver disease experienced a
decline in health, and was unable to develop a normal life-style pattern
or to do normal active work.
The two patients with malignant tonsil conditions
ended the biomedical experience with a worsening of their initial Karnofsky's
indexes. However, one of them was able to experience the development of
a normal activity with minor signs and symptoms of disease (ordinofagia
improved greatly).
Patients with esophageal and gastric cancers did
poor on Karnofsky's indexes, although a very initial positive response
was found in one patient esophageal cancer, but it did not consolidate.
The only patient with primitive
urinary bladder cancer was seriously impaired by his metastatic liver condition,
and finally died as a consequence of this.
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