Professional Documents
Culture Documents
TABLE OF CONTENTS
1. INTRODUCTION
1.1. Background
1.2. Hypothesis
2. STUDY OBJECTIVES
3. STUDY DESIGN
4. PATIENT WITHDRAWAL
5. TREATMENT ADMINISTERED
6. EFFICACY VARIABLES
8. DATA COLLECTION
8.1 Demographics
10. REFERENCES
1. INTRODUCTION
1.1. Background
Breast cancer is a cancer of the glandular breast tissue. Worldwide, breast cancer is the
fifth most common cause of cancer death (after lung cancer, stomach cancer, liver cancer,
and colon cancer). In 2005, breast cancer caused 502,000 deaths (7% of cancer deaths;
almost 1% of all deaths) worldwide. Among women worldwide, breast cancer is the most
common cancer and the most common cause of cancer death.[1]
In the United States, breast cancer is the third most common cause of cancer death (after
lung cancer and colon cancer). In 2007, breast cancer is expected to cause 40,910 deaths
(7% of cancer deaths; almost 2% of all deaths) in the U.S.[2] Among women in the U.S.,
breast cancer is the most common cancer and the second most common cause of cancer
death (after lung cancer). Women in the U.S. have a 1 in 8 lifetime chance of developing
invasive breast cancer and a 1 in 33 chance of breast cancer causing their death.[3]
The number of cases has significantly increased since the 1970s, a phenomenon partly
blamed on modern lifestyles in the Western world.[4][5]
Because the breast is composed of identical tissues in males and females, breast cancer
also occurs in males, though it is less common.[6]
There are numerous ways breast cancer is classified. Like most cancers, breast cancer can
be divided into groups based on the tissue of origin, e.g. epithelial (carcinoma) versus
stromal (sarcoma). The vast majority of breast cancers arise from epithelial tissue, i.e.
they are carcinomas, which can divided further into subclassifications (e.g. DCIS versus
LCIS versus papillary carcinoma).
• Location of the tumour origin - breast duct (i.e. ductal) versus breast lobule (i.e.
lobular).
• Histology - see Histologic types section.
• Grade of tumour - well-differentiated (looks almost like normal tissue) versus
poorly differentiated (does not look like any normal tissue/mass of proliferating
cells) versus moderately differentiated (somewhere between poorly differentiated
and well-differentiated).
• Stage of the tumour.
CAM is a growing field in health care and particularly among breast and other cancer
patients. Knowledge of CAM by physicians, especially oncologists, is necessary.
Oncologists should be willing to discuss the role of CAM with their patients and
encourage patients to participate in well-organized research about CAM.(8)
Metal therapy, according to Ayurvedic texts which are thousands of years old, is based on
the premise that human body tissues contain different metals in various degrees. Any
imbalance in the content of these metals, caused by natural or self-inflicted methods such
as substance abuse, disturbs the body and triggers ailments. The patients can be treated
with metal-based drugs that replace the balance. Metal therapy rests on the belief that all
ailments can be treated with metal-based drugs if they are diagnosed correctly and in
time. All metals including gold, silver, mercury, arsenic, iron, copper, lead, tin and zinc
and their alloys and some wastes are used to make the drugs. Metals (ionised form which
can be absorbed by the human body) have a very important role to play in the prevention
and cure of cancer.
"The same metal can be mixed with different herbs and processed to treat different
diseases," Dr R M Anand, an assistant director at state-run Central Council for Research
in Ayurveda and Siddha (CCRAS), told Reuters. He said metals are first purified in
herbal decoctions, oxidized, subjected to heat and crushed several hundred times till they
are converted into a non-metallic, non-toxic form that can be absorbed by the body. The
drugs are either in the form of tablets or powders.(9)
Traditional knowledge will serve as a powerful search engine and most importantly, will
greatly facilitate intentional, focused and safe natural products research to rediscover the
drug discovery process. Benefits in health care and improvement of quality of life.Natural
harmaceuticals (Naturaceuticals), nutraceuticals and cosmeceuticals are of great
importance as a reservoir of chemical diversity aimed at new drug discovery and are
explored for antimicrobial, cardiovascular, immunosuppressive and anticancer drugs. US
FDA has granted approvals to many biotechnology-based products, including Novartis:
Gleevec – for treatment of CML; Genezyme: Carticel – cartilage regeneration; Immunex:
Enbrel – for RA; Genentech: Herceptin – for Breast cancer; CDR Therap: Integrilin – for
heart diseases; Organogenesis: Apligraft – a skin substitute. Over 300 drugs are in Phase
III and over 200 are expected to be in the market by 2007.(10,11)
In a study arsenic compounds are effective agents in the treatment of APL and their
activity against other types of cancer requires further investigation. Treatment of newly
diagnosed and relapsed patients with acute promyelocytic leukemia (APL) with arsenic
trioxide (As2O3) has been found to result in complete remission (CR) rates of 85-93%
when given by intravenous infusion for 2-3 h at a dose of 10 mg/day diluted in 5%
glucose saline solution.(12)
Extract of Tinospora cordifolia has been shown to inhibit the lipid peroxidation and
superoxide and hydroxyl radicals in vitro. Concentration needed for 50% inhibition was 6
mg and 12.5 mg/ml, respectively. The extract was also found to reduce the toxic side
effects of cyclophosphamide administration (25 mg/kg b.wt, 10 days) in mice
hematological system by the free radical formation as seen from total white blood cell
count, bone marrow cellularity and alpha-esterase positive cells.(13)
Exposure of HeLa cells to 0, 5, 10, 25, 50 and 100 microg/ml of guduchi extracts
(methanol, aqueous and methylene chloride) resulted in a dose-dependent but significant
increase in cell killing, when compared to non-drug-treated controls.(14)
The metal based formulations have been found to be effective in the successful treatment
of leukaemia. In 1996, Ministry of Health and Family Welfare again reviewed my results
and a pilot project entitled ‘Effect of metal based formulation in the treatment of 30
patients of Acute Promyelocytic Leukemia (APML)’ was sanctioned by CCRAS under
the supervision of Cancer Research Committee headed by Dr Dinesh Chandra, Professor
and Head, Department of Pharmacology, Maulana Azad Medical College, Delhi. The
other members of the committee were Haematologist and Oncologist from AIIMS and
experts from ICMR and CCRAS.(15)
Although there is no certain treatment for cancer in ayurveda, it can help in restoring the
normal functioning of organs and enable the body to fight disease to a certain extent. It
does not have specific medicines to kill cancer cells, but works more as a supplemental
therapy towards overall management of the disease. Some ayurvedic physicians claim
having achieved positive results in treatment with heerak bhasma (a medicine prepared
from diamonds).(16)
Tamra bhasma purifies the blood. It has the qualities of Swarna Bhasma. Tamra Bhasma
(Cupric oxide) is Useful in leprosy, asthma, bronchitis, cough, consumption, anaemia,
piles, liver trouble etc.(17)
Involving 400 cancer patients, the Ayurvedic formulation containing herbal drugs
bhallatak (Semecarpus anacardium), rohitak (Amoora rohitaka), madhuyasti (Glycyrrhiza
glabra), and tamra bhasma was evaluated alone or in combination with other treatment
modalities, chemotherapy, and radiotherapy.The patients were monitored for 10 years(18)
In 400 BC, Ayurvedic surgeon Sushrut described various cancers (called arbud) and their
surgical and holistic therapy in his textbook of surgery. In addition to surgical treatment,
Ayurvedic physicians observed and documented the effects of various natural therapies,
spiritual practices, yoga, meditation and herbal and mineral preparations on cancer.
(19,20,21)
1.2. Hypothesis
Many ayurvedic formulations and Herbs given in traditional texts used by ayurvedic
practitioners for long times like Heerak Bhasma, Ras Manikya, Swarn Basant Malti, Tal
Sindur, Amrita sat etc. are looking very much useful in different types of carcinomas,
may be due to lekhan properties of these drugs and pranayama.
2. STUDY OBJECTIVES
The assessment of relative importance of Herbomineral Preparation by Divya Pharmacy
in Womens with Non-Metastatic Breast patients especially pathological and symptomatic
changes. The result of this study will decide long term study on different type of
carcinoma patients.
3. STUDY DESIGN
Sixty newly diagnosed Non- Metastatic Breast Cancer Patients patients will be recruited
and randomized in a 1 (Conventional regime) : 1 (ayurvedic regime
fashion and followed for at least two years.
Treatment failure:
Outcomes:
- Mortality
- Treatment failure
A subject will be included in the study only if all the following criteria apply:
A subject will not be eligible for inclusion in the study if any of the following criteria
apply:
A maximum of 7-8 days elapse between screening and the start of treatment. Patients will
be randomized and assigned an identification number during the screening visit.
2. Physical examination.
2. Height, Weight
3. Primary disease.
Visit one will take place around 45 days after treatment starts.
1. Physical examination.
2. Weight
Treatment period continues for twelve months. Patients will be with drawn from the
study if they have life threatening problem.
1. Physical examination.
1. Treatment regime
2. Weight
4. PATIENT WITHDRAWAL
Patients are withdrawn from the study for any of the following reasons:
1. Completion of study
2. Patient preference
3. Death
4. Physician discretion
5. TREATMENT ADMINISTERED
1 Anti Cancer Drug (Mixture of certain drugs of Ayurveda widely used for different
treatments)
1 Conventional solution (Chemo/Radiotherapy)
The conventional regime i.e. chemotherapy given by premier hospital or institution will
be selected for the study.
Extract of
Panwar Cassia tora 100
Daruhaldi Barberis aristata 100
Karanj Pongamia pinnata 100
Amla Emblica officinalis 100
Giloy Tinospora cordifolia 100
Kutki Picrirhiza kurroa 100
Bakuchi Phal Psoralia corylifolia 100
Bahera Terminalia chebula 100
Kali Jeeri Centratherum anthelminticum 100
Choti Kateli Solanum surattense 100
Haldi Curcuma longa 100
Khair Acacia catechu 100
Nimb Azadirachta indica 100
Manjeeth Rubia cordifolia 100
Chirayita Swertia chirayita 100
Dronpushpi Leucas cephalotes 100
Harad Termenalia bellerica 100
Indrayanmool Cirullus colocynthis 100
Devdaru Cedrus deodara 100
Usba Smilex arnata 100
Punarnavamool Boerhavia diffusa 100
Bhuiamla Phyllanthus urinaria 100
Makoy Solanum nigrum 100
Sadampushpa Lochnera rosea 100
Ashwagandha Withania somnifera 100
Powders of
Heerak Bhasma 5
Sila Sindur 80
Tamra Bhasm 8.3
Swarn Basant Malti 25
Amrita Sat 80
Mukta Pishti 41.5
Praval Panchamrit 41.5
Kanchanar Guggul 330
Vrddhivadhika Vati 165
1 tab. Or capsule of Karkatnashini will be given to patients with 50ml. fresh juices of
wheat grass and guduchi - Tinosporsa cordifolia (25 ml. each) twice in a day half n hour
before breakfast and dinner.
6. EFFICACY VARIABLES
Marker Tests (CA 15.3, CA125), DR-70, Thermography, Ductal levage T/Tn Antigen Test,
between the treatment and control groups.
1. The secondary outcome will be significant changes in Hb %, WBC (White blood cells)
count, Platelets counts etc.
2. Psychological measures of mood, stress and QOL using: POMS, PSS-10, Cook-
Medley and SF-36 questionnaires.
7.2. Randomization
A secondary as-treated analysis will also be performed based solely on those patients
deemed to be evaluable throughout the study. This as-treated analysis will directly access
the effectiveness of treatment regime with respect to the primary and secondary outcome
variables.
8. DATA COLLECTION
8.1. Demographics
9.1. Acueity ductoscopy is a patented optical system and ductoscope, about the size of a
pencil tip, enable physicians to look through the nipple directly into the milk ducts --
areas previously inaccessible to medical intervention -- where 85% of breast cancer
develops. Their system of microendoscopes, coupled with patented OptiCueTM optical
technology results in large, clear and sharp video images of the mammary duct system,
with unprecedented depth of field perception and detects lesions as small as 0.2 mm in
diameter (50 times more sensitive than a standard mammogram)
9.2. Amas test : This test can be the first choice to check for breast cancer. The AMAS
test detects malignant growth only (not benign tumors) and is more sensitive than
mammograms. If the AMAS is positive, further tests are warranted as the AMAS doesn't
indicate Where the cancer is located, only that there is cancer within the body. In
addition, the AMAS test can be used to follow breast cancer patients who are in
remission, since the AMAS returns to normal within 3 months after the breast tumor (and
metastases, if present) are removed or eradicated.
9.3. CA 15.3 values are often elevated in patients with breast cancers. When there is a
history of cancer among family members, patients may be advised to also do a breast
mammogram. Besides breast cancer, other non-malignant conditions (eg. cirrhosis,
benign diseases of ovaries & breast) have also been known to cause elevated CA 15.3
levels.
CA125 has become a widely used tumor marker which is measured most often in women
with cancers of the reproductive system including the uterus, fallopian tubes and ovaries.
Other cancers that may cause abnormal CA125 levels include cancer of the pancreas,
lungs, breast and colon. However, CA125/CA125-II can be elevated during menstruation,
pregnancy or in individuals with ovarian cysts, pericarditis, hepatitis, cirrhosis of the liver
or peritonitis, an infection of the lining of the abdomen, and even in 1-2% of healthy
individuals. Once a cancer is diagnosed, CA125/CA125-II levels may prove to be an
effective indicator of the effectiveness of cancer treatment. A declining CA125/CA125-II
value may indicate a good response to treatment and a favorable prognosis. Persistently
rising CA125/CA125-II levels may be associated with a growing tumor, presence of
tumor on the peritoneum that lines the abdomen or a recurrence of a previously treated
tumor. Additional evaluation is necessary to make such determinations. CA 125-II, an
improved version of the original CA 125 assay, is now commercially available.
9.4. DR-70 is a simple blood test that screens for 13 different cancers at the same time. It
is highly specific and catches cancer long before you would suspect anything was amiss.
Cancers that can be detected by the test are of the lung, colon, breast, stomach, liver,
rectum, ovary, cervix, esophagus, thyroid, and pancreas, and trophoblast and malignant
lymphoma. AMDL has also received clearance from the FDA to market the
PyloriProbe™ test, which can detect the presence of Helicobacter Pylori in the stomach,
the primary cause of ulcers and a potential cause of stomach cancer.
9.5. Thermography uses thermal imaging which detects new blood vessels and
chemical changes associated with a tumor’s genesis and growth. Thermography measures
the radiation of infrared heat from our body and translates this information into
anatomical images. Thermography offers a very early warning system, often able to
pinpoint a cancer process years before it would be detectable by mammography. This
approach can detect cancer when they are at a minute physical stage of development,
when it is still relatively easy to halt and reverse the progression of the cancer. Most
breast tumors have been growing slowly for up to 20 years before they are found by
typical diagnostic techniques. When used as part of a multi-modal approach (clinical
examination + mammography + thermography) 95% of early stage cancers can be
detected.
9.5. T/Tn Antigen Test developed by Dr. Georg Springer can detect the majority of
cancers before any biopsy can pick up the presence of cancer. The T and Tn antigens are
proteins on the surface of blood and skin cells and can be identified by the immune
system antibodies. The concentration of these antigens vary depending on the cancer type
and stage. A skin prick can predict or indicate the likely development of cancers, even 6-
10 years in advance of other tests. The test appears to successfully diagnosis about 94%
of lung cancers and 80% of breast cancers. More information about the test can be
obtained by calling the Chicago Medical School at (847) 578-3435.
1. Haematology
RBC count
Hb%
WBC count
TLC
DLC
MCV
MCH
MCHC
Platelet count
2. Biochemistry
Glucose
Albumin
Total protein
Total bilirubin
Urea
Creatinine
Total cholesterol
HDL
LDL
Triglyceride
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