CLINICAL RESEARCH PROTOCOL
Adjuvant Homoeopathic Management for breast cancer patients experiencing side
effects from chemotherapy-An observational pilot study
Regulatory Sponsor:
Central Council for Research in Homoeopathy, New Delhi
Funding Sponsor:
Central Council for Research in Homoeopathy, New Delhi
Study Product:
A Pilot Study
Study Team
Chief Coordinator
Dr. Alok Kumar, Director General In-charge
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janak puri
New Delhi-110058
Co-Chief Coordinator
Dr. Vikram Singh, Deputy Director (H)
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janak puri
New Delhi-110058
Coordinator
Dr. Jaya Gupta, Assistant Director (H)
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janak puri
New Delhi-110058
Co- Coordinator
Dr. Chetna Deep Lamba, Research Officer(H)
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janak puri
New Delhi-110058
Investigators at centers
Dr. D.B.Sarkar, AD(H), RRI(H), Kolkata
Consultant Oncologist
Dr. Sanjoy Das
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Protocol preparation team
1. Dr. Jaya Gupta, AD (H), CCRH, HQS.
2. Dr. D.B. Sarkar, AD(H), RRI(H), Kolkata
3. Dr. Chetna Deep Lamba, RO(H), CCRH, HQS.
Initial version: [22.6.11]
Amended: [date]
Amended: [date]
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STUDY SUMMARY
Title
Short Title
Protocol Number
Phase
Methodology
Study Duration
Study Center (s)
Objectives
Adjuvant Homoeopathic Management for breast cancer patients experiencing side effects from
chemotherapy-An observational pilot study
Adjuvant Homoeopathic Management for side effects from chemotherapy in breast cancer patients
Version 1
Clinical Study Phase 1
Observational Pilot study
16months
Single centre
Primary Objective

To study the usefulness of predefined homoeopathic medicines for combating the
side effects of chemotherapy in breast cancer patients using Edmonton Symptom
Assessment Scale: Revised Version
Secondary Objectives
Number of Patients

To study the usefulness of homoeopathic medicines in the treatment of cancer
patients

The quality of life using EORTC QLQ-C30 and QLQ-BR23

To see the changes in CA 15.3 after Homoeopathic treatment

To find the clinical symptoms of homeopathic medicines used during trial, if any to
enrich the Materia Medica
30 cases shall be recruited and if positive response is found, then all patients fulfilling
inclusion criteria shall be enrolled up to 1 year.
Main Inclusion
Criteria
Patients meeting all of the following criteria will be eligible for study participation:

Females, 18 years or over, with any stage of any type of breast cancer undergoing
chemotherapy

Patient having any two of the following side effects of chemotherapy viz. nausea,
vomiting, abdominal pain, diarrhea, constipation, decreased appetite, hair loss
within 2 weeks of chemotherapy

Patient should not be under Homoeopathic treatment for the side effects of
chemotherapy

Patients able to take self care

Patients willing to sign written informed consent
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
Study Product, Route
Duration of
administration
Reference therapy
Statistical
Methodology
Outcome measures
Hb% more than 6.5 gm%
Homoeopathic medicines, Oral route
4months
Wilcoxon sign rank test, repeated measures and other appropriate test will be done during final
analysis of the result.


Edmonton Symptom Assessment Scale: Revised Version
EORTC QLQ-C30 and QLQ-BR23
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1.
TITLE OF THE RESEARCH PROJECT
Adjuvant Homoeopathic Management for breast cancer patients experiencing side effects from chemotherapyAn observational pilot study
2.
PROJECT SUMMARY
An observational pilot study of homoeopathic medicines in combating the side effects of chemotherapy in breast cancer
patients will be carried out by Central Council for Research in Homoeopathy, at its Dr. Anjali Chatterjee Regional Research
Institute for Homoeopathy, Kolkata. Female participants 18 years and above, having breast cancer and presenting with
side effects of chemotherapy shall be enrolled in the study. Homoeopathic medicines shall be used in the study.
Assessment shall be done as per Edmonton Symptom Assessment Scale (Revised Version), EORTC QLQ-C30 and QLQBR23. On conclusion of the study, the data obtained shall be statistically analyzed with the help of a suitable statistical
package (SPSS statistical package version 16) to see the usefulness of homoeopathic medicines in combating the side
effects of chemotherapy and the results shall be disseminated to the medical fraternity.
3.
JUSTIFICATION FOR THE STUDY AND USE OF THE RESULTS
Chemotherapy is the use of anticancer drugs to treat cancerous cells. Chemotherapy has been used for many years and
is one of the most common treatments for cancer. In most cases, chemotherapy works by interfering with the cancer
cell's ability to grow or reproduce. Different groups of drugs work in different ways to fight cancer cells. Chemotherapy
may be used alone for some types of cancer or in combination with other treatments such as radiation or surgery. Often,
a combination of chemotherapy drugs is used to fight a specific cancer. Certain chemotherapy drugs may be given in a
specific order depending on the type of cancer it is being used to treat. While chemotherapy can be quite effective in
treating certain cancers, chemotherapy drugs reach all parts of the body, not just the cancer cells. Because of this, there
may be many side effects during treatment. 1Homoeopathic literature has many drugs in its armamentarium which can
combat the side effects of chemotherapy. Therefore, the present study is proposed to find the usefulness of
homoeopathic medicines. The result of this study will help the profession to get valid data about the usefulness of
homoeopathic medicines in better management of side effects of chemotherapy.
4.
BACKGROUND
Although no documented study is found on the treatment of side effects of chemotherapy with Homoeopathy but there
are evidences of positive role of Homoeopathy in cancer.
In a prospective observational study on 45 patients with CA Breast, 38 had hot flushes. Other symptoms like mood
disturbances, joint pains, fatigue, sleeplessness, etc. were also present in these patients. Significant improvement was
seen in HF and quality of life also showed an improvement.2
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In a prospective observational study of Homeopathic treatment of radiation-induced itching in breast cancer
patients, twenty-five patients were treated homeopathically for radiation-induced itching. Altogether 21 of 25
(84percent) patients were successfully treated.3
A randomized double-blind placebo-controlled clinical trial involving 66 patients who had been operated on for breast
cancer and were undergoing radiotherapy was conducted. The differences of the scores of the Index of Total Severity
during Radiotherapy were not statistically significant, but showed a trend towards a better activity of the homoeopathic
medicine compared to placebo. Analysis of the data on Total Severity during recovery, showed a statistically significant
benefit of the active medicines over placebo.4
A prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under
complementary homeopathic treatment (HG; n=259), and one cohort with conventionally treated cancer patients (CG;
n=380). An improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under
complementary homeopathic treatment was observed.5
Four ultra-diluted remedies (Carcinosin, Phytolacca, Conium and Thuja) were studied against two human breast
adenocarcinoma cell lines (MCF-7 and MDA-MB-231) and a cell line derived from immortalized normal human mammary
epithelial cells (HMLE). The remedies exerted preferential cytotoxic effects against the two breast cancer cell lines, causing
cell cycle delay/arrest and apoptosis.6
In a trial of postoperative adjuvant chemotherapy women with primary breast cancer and spread to one or more axillary
nodes were randomised to receive a six-month course of either the single agent chlorambucil or the five-drug
combination of chlorambucil, methotrexate, fluorouracil, vincristine, and adriamycin. On completing the treatment 47
patients were asked to fill in questionnaires at home on the side effects of treatment and its influence on the quality of
their life. Side effects including nausea, vomiting, malaise, and alopecia had been severe enough to interfere with their
lifestyle in 9 (42%) of the patients who had received the single agent and 19 (79%) of those who had received multipledrug treatment. Various other side effects were reported by a few patients.7
5.
STUDY OBJECTIVES
5.1.
Primary Objective
To study the usefulness of homoeopathic medicines for combating the side effects of chemotherapy in breast cancer
5.2.
patients using Edmonton Symptom Assessment Scale (Revised Version)8
Secondary Objectives




6.
To study the usefulness of homoeopathic medicines in the treatment of cancer patients
The quality of life using EORTC QLQ-C30 and QLQ-BR239
To see the changes in CA 15.3 after Homoeopathic treatment
To find the clinical symptoms of homeopathic medicines used during trial, if any to enrich the Materia Medica.
Operational Definition of Variables
I. Common Side effects of Chemotherapeutic drugs used for breast cancer therapy10

Anorexia

Nausea
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















Vomiting
Diarrhoea
Constipation
Stomatitis
Hair loss
Altered mental status including anxiety, depression and drowsiness
Local irritation
Rash
Dermatitis
Facial flushing
Conjunctivitis
Lachrymation
Myalgia
Sensory neuropathy
Fever and flu like symptoms
Decrease in blood counts
II. Edmonton Symptom Assessment Scale: (Revised Version)
The ESAS has been revised to improve ease of understanding and completion for patients. The revised version of the tool
is known as the ESAS-r. The ESAS-r is intended to capture the patient’s perspective on symptoms. However, in some
situations it may be necessary to obtain a caregiver’s perspective. The ESAS-r provides a profile of symptom severity at a
point in time. Repeated assessments may help to track changes in symptom severity over time. The ESAS-r is only one
part of a holistic clinical assessment. It is not a complete symptom assessment in itself.
III. Health Related Quality of Life: EORTC QLQ-C30 and QLQ-BR23
The European Organisation for Research and Treatment of Cancer quality of life questionnaire and breast cancer subscale
are chosen for the reliability and generalisability for this specific cancer patient group.
IV. Centesimal potencies
The potencies used in centesimal scale are known as centesimal potencies. This was introduced by Dr. C. F. S. Hahnemann in
5th edition of Organon of Medicine in aphorism 270.
V. Aggravation
Heightening of present symptoms of patient or overall worsening of patient’s condition. It may be of three types:
Homoeopathic Aggravation: Because homoeopathic medicines are capable of producing similar symptoms as those of
disease symptoms in somewhat higher degree, symptoms seems to be aggravated, after administering the most correct
similimum ,this is called as homoeopathic aggravation. A quick and short homoeopathic aggravation is mostly desired after
administration of homoeopathic medicines.
Medicinal Aggravation: Because of overdosing of medicines or when a partially indicated medicine is applied, some of the
medicinal symptoms (non-homoeopathic symptoms) appear in a patient which is called as medicinal aggravation.
Disease Aggravation: As a process of natural history of disease, disease condition aggravates which is called as disease
aggravation. This happens when a wrong medicine has been employed
VI. Amelioration/ relief
Decrease in symptom score or improvement in general condition of patient or both is called as Amelioration or relief.
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VII. Status quo
No change in patient’s condition.
VIII. Adverse event
An adverse event is any symptom, sign, illness or experience that develops or worsens in severity during the course of the
study. Intercurrent illnesses or injuries not responding to homoeopathic treatment should also be regarded as adverse
events.
7.
METHODOLOGY
7.1
Type of Study and General Design
This will be single centre, observational pilot study.
7.2
Site of the study
Regional Research Institute, Kolkata under the Council.
7.3.
Duration of study
16 months including follow up period of 4months for each patient.
7.4.
Sample Selection and Size
30 cases shall be recruited and if positive response is found, then all patients fulfilling inclusion criteria shall be enrolled
up to 1 year.
7.5.
Selection Criteria
The cases shall be referred by the Consultant Oncologist/Surgeon of NIH, Kolkata and from OPD of RRI, Kolkata and
enrolled on the basis of presenting symptoms/signs of side effects of chemotherapy and laboratory investigational
screening.
7.5.1.
Inclusion criteria
Patients meeting all of the following criteria will be eligible for study participation:

Females, 18 years or over, with any stage of any type of breast cancer undergoing chemotherapy

Patient having any two of the following side effects of chemotherapy viz. nausea, vomiting, abdominal pain,
diarrhea, constipation, decreased appetite, hair loss reporting within 2 weeks of chemotherapy.
7.5.2.

Patient should not be under Homoeopathic treatment for the side effects of chemotherapy

Patients able to take self care

Patients willing to sign written informed consent

Hb% more than 6.5 gm%
Exclusion criteria
Patients meeting any of the following criteria will be excluded:
 Inability to comply with the study protocol, including psychiatric disease
 Features of renal failure (urea more than 50 mg%, creatinine more than 2 mg %)
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 Features of gastro intestinal obstruction
 Patients deemed ineligible by the investigator
7.6.
Investigations
 Complete haemogram
 LDH*
 ER
 PR
 CA 15.3(At entry and after 3 months)
 Liver function test
 Kidney function test
 HbA1C level (<8%)
*As advised by the Consultant
7.7. Primary end point

To assess the changes in Edmonton Symptom Assessment Scale: Revised Version (ESAS-r) on 3rd and 7th day of
homoeopathic treatment after each chemotherapy session.
7.8. Secondary end points

To assess the Health Related Quality of Life: EORTC QLQ-C30 and QLQ-BR23 at 1st and 7th day of homoeopathic treatment
after each chemotherapy session.
7.9. Primary safety end points
Any adverse event in the study group
8.
Unit of analysis and Observation
 Female Breast cancer patients presenting with side effects of chemotherapy will be considered for the trial. The
patients will be enrolled after taking consent and if found eligible after examination by the Consultant.
 Edmonton Symptom Assessment Scale: Revised Version (ESAS-r) shall be filled on 3rd and 7th day of homoeopathic
treatment after each chemotherapy session by any convenient means.
 EORTC QLQ-C30 and QLQ-BR23 is to be filled at entry and on 7th day of homoeopathic treatment after each
chemotherapy session.
 Follow up will be done on 3rd and 7th day after 1st chemotherapy session and subsequently 1st, 3rd and 7th day of
subsequent chemotherapy sessions after homoeopathic intervention. If the patient is not reporting on due date
then contact should be made by any means and details should be recorded.
 Final assessment shall be done after 4 months. Final assessment shall be done by the statistician as per the
directions given in the module of the scales.
8.1
Enrolment process
The enrollment process will have 4 stages of participant selection before trial of homoeopathic therapy commences.
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Stage 1: Screening by the OPD doctor/ investigator
Participants shall be recruited from those coming to Out Patients’ Department of the centre and those referred by the
Consultant Oncologist/Surgeon of the study from NIH, Kolkata. The Institute will evolve its own advocacy procedures for
attracting research subjects (advertisements, media, camps, handouts, etc.) if found necessary. The Institute will follow
the standard recruitment procedure. The procedure involves a screening prior to initiation of the consent procedure
[Annexure 1].
Stage 2: Written informed consent
One who is eligible to enter the study as per Annexure 1will be fully informed about the study as mentioned in the patient
information sheet [Annexure 2] in the regional language. The investigator will obtain written informed consent of the
patients prior to Case Taking on written informed consent form [Annexure 3]. If the patient does not happen to be literate,
left hand thumbprint may be substituted for signature, duly witnessed by somebody in addition to the person requesting
consent.
Stage 3: Investigations [Annexure 4]
 Complete blood count
 LDH*
 ER
 PR
 CA 15.3
 Liver function test
 Kidney function test
 HbA1C level (<8%)
*As advised by the consultant.
Stage 4: Enrolment of the patients
The patients fulfilling inclusion criteria shall be enrolled in the study.
Stage 5: Case Recording
The patient shall undergo Case recording after chemotherapy [Annexure 5]. After detailed case taking, acute totality should
be build up.
Stage 5: Baseline assessment


Edmonton Symptom Assessment Scale: (Revised Version) [Annexure 6]
EORTC QLQ-C30 and QLQ-BR23 [Annexure 7]
9.
Proposed Intervention (Homoeopathic)
9.1.
Source of medicine
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The medicines in 30C and 200C dilutions manufactured by a licensed homoeopathic pharmaceutical company approved
by the Council shall be procured.
9.2.
Selection of medicine
Selection of the medicine will be done after case taking on the basis of presenting totality of symptoms. The prescription
shall be justified from Materia Medica or Repertory.
9.2.1. Prescription

Selection of Potency: The indicated medicine shall be given in 30c or 200c potency as per the need of the case.

Dose: Each dose of indicated medicine shall consist of four globules (size no. 30).
9.2.2. Repetition of doses
Indicated medicine may be repeated every few minutes to hours depending on the intensity of the symptoms and
susceptibility of the patient as follows:
 6 hourly- in mild cases
 4 hourly- in moderate cases
 Few minutes to 2 hourly- in severe cases
9.3. Follow up [Annexure 8]
In case of symptomatic improvement, the patient shall be on placebo till the improvement continues. Subsequently, when the
improvement ceases or in case of aggravation, prescription shall be on the basis of presenting totality of symptoms. In case of any
intercurrent diseases, the investigator shall treat the patient accordingly and record shall be maintained.
10. Chemotherapy regimen
The following medicines in different combinations administered to the patient by the Consultant Oncologist as per the
requirement-
11.
1. Carboplatin
2. Cyclophosphamide
3. Doxorubicin/Epirudicin
4. Pacli taxel
5. Gemcitabine
6.Fluorouracil (5-FU)
7. Tamoxifen
8. Estrogen
9. Progesterone
ETHICAL REVIEW
The study protocol will be in accordance with the latest revision of the Helsinki, declaration on human experimentation.
Although homoeopathic medicines, proposed to be used during the study, are homoeopathic pharmacopeal preparations
(no new drug is proposed to be tried) yet necessary clearance of the Ethical Committee and Scientific Advisory Committee
shall be obtained for this study.
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12.
PLAN FOR ASSESSMENT AND ANALYSIS OF RESULTS
 All the patients will be taught to recognize the signs of worsening & improvement of the illness. They will be advised
to report to the Institute if any of the signs develop at any time before the scheduled visit.
 Edmonton Symptom Assessment Scale: Revised Version (ESAS-r) shall be filled on 3rd and 7th day of homoeopathic
treatment after each chemotherapy session by any convenient means.
 EORTC QLQ-C30 and QLQ-BR23 is to be filled at entry and on 7th day of homoeopathic treatment after each
chemotherapy session.
 Complete Haemogram, ER, PR and CA 15.3 shall be done at the end of 4months
 Final assessment shall be done after 4months. Final assessment shall be done by the statistician as per the directions
given in the module of the scales.
 If the patient does not report on a fixed date effort shall be made to contact him/her in any way. The data will be
maintained in a excel sheet so that it can be procured every month and when necessary for interim analysis.
 In the eventuality of an adverse event, the participant shall be referred for appropriate medical care. Throughout
the trial, participant shall be at liberty to withdraw her consent or refuse to continue treatment. Those who
withdraw from the trial without prior intimation and stop coming for follow up or further treatment shall be treated
as not reported. The participants i.e. withdrawn and not reported shall be treated as drop-out for compilation of
final data at the conclusion of the study.
13.
PROGRAM TO BE USED FOR DATA ANALYSIS
The SPSS statistical package version 16 will be used to analyze the data. Wilcoxon sign rank test, repeated measures and
other appropriate test will be done during final analysis of the result.
14.
PREMATURE WITHDRAWAL OF THE PATIENT
Every patient is free to withdraw from the trial at any time for any reason and without prejudice, or may withdraw on the
advice of the investigator.
Furthermore, premature withdrawal of the patient is possible, in case of any adverse event which needs referral of the
patient.
Any patient who withdraws from the trial will undergo a complete final examination if possible, or at least a final
telephone interview at the time of withdrawal from the study, with regard to the state of the patient's health, and if
necessary, also from the point of view of drug safety and the validity of study results. The reasons for the withdrawal are
to be recorded in the in the patient's case record.
15.
PREMATURE STUDY TERMINATION
The Council is entitled to terminate the trial prematurely at any time for medical and/or organizational reasons. This
decision will normally be made on the recommendation of the Council.
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Should the trial be terminated prematurely, as far as possible each individual patient should undergo a complete final
examination or at least a final telephone interview, with regard to the state of the patient's health, and if necessary, from
the point of view of drug safety and validity of the trial results.
16.
RECORD HANDLING
16.1 Record keeping
The original records of patients will be maintained at the study center and the photocopies of the same will be sent to the
CCRH headquarters on completion of study and photocopies will be kept by the investigator. The original records will be
handed over to the In-charge which will be preserved at the Institutes / Unit level for five years. The center will send
monthly report. Final concluding report shall be submitted to Hqrs. within 45 days of conclusion of the study.
16.2
Study management at site
The center will be responsible for setting up an information system to keep track of all patients screened, enrolled and
will maintain a filing system to keep all study records –study protocol, related documentation and medicine distribution
records. The investigator is responsible for the completeness and accuracy of the study materials.
17.
MONITORING AND INSPECTION
Project monitoring and reviews:
Each enrolled case record will be submitted to the study coordinator at CCRH headquarters as soon the case is enrolled
for verification of the case record with all forms. Monitoring at site will be conducted during the study period for protocol
compliance.
18.
TRAINING
Training will be imparted to the investigator at CCRH headquarters.
19.
PROTOCOL AMENDMENTS
The investigator has to meet the study requirements as specified in the protocol.
Protocol amendments are possible only in exceptional cases (e.g. where the health or well-being of the patient is
affected) and only after authorization by the Council. Every amendment must be justified in writing and signed by all
those concerned. Circulating protocols will be numbered and a list of their distribution will be remained. The investigator
will update all circulating protocols by adding the amendment.
In the case of administrative or technical amendments which do not affect the health of patients, an administrative
change is possible after agreement of all those concerned. These are also to be justified in writing and all those
concerned are to be informed.
Should a protocol amendment change the design of the trial fundamentally, or increase the potential risk to patients, a
renewed approval by the Ethics Committee and Protocol Review Board as well as a renewed patient's informed consent is
required, also from those patients already enrolled into the trial, as far as they are affected by this change.
20.
COMMUNICATION/ PUBLICATION OF STUDY RESULTS
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All data derived from the study shall be the property of the Council.
The papers on the outcome from the study shall be published under joint authorship (task force study).
Authorship credit shall be based on 1) substantial contributions to conception and design, or acquisition of data, or
analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3)
final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
21.
LIMITATIONS OF STUDY
Non-achievement of sample size at the Institute –
i.
In case of non achievement of sample size in the study period, there will be option for extension of the study for a
further limited period after due approval of Scientific Advisory Committee of the Council.
ii.
If the center fails to achieve the sample size in 12 months, or not complying to the protocol, the study will be
discontinued and there will be an option for inclusion of one more center after due approval of Scientific Advisory
Committee.
22. TIME LINE
Draft protocol, submit to EC
June 2011
Recruitment in main study
After approval from SAC and registration with CTRI.
Completion of study
16 months from the day of initiation.
Data compilation and analysis
3months after completion of study.
23. REFERENCES
1. http://cancer.stanford.edu/information/cancerTreatment/methods/chemotherapy.html accessed on 20.06.2011.
2. Thompson, E.A., Reilly, D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast
cancer patients: A prospective observational study. Homeopathy. 2003; 92:131-134.
3. O Schlappack. Homeopathic treatment of radiation-induced itching in breast cancer patients. A prospective
observational study. Homeopathy | 2004 October | 93 | 4 | | 210-215
4. A Balzarini, E Fellisi, A Martini, F De Conno. Efficacy of homeopathic treatment of skin reactions during radiotherapy for
breast cancer: a randomized, double-blind clinical trial. Homeopathy | 2000 January | 89 | 1 | | 8-12.
5. Matthias Rostock et al. Classical homeopathy in the treatment of cancer patients - a prospective observational study of
two independent cohorts. BMC Cancer |2011| 11|19 doi:10.1186/1471-2407-11-19
6. Moshe Frenkel et al. Cytotoxic effects of ultra-diluted remedies on breast cancer cells. International Journal of
Oncology.
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7. B V Palmer, G A Walsh, J A McKinna, and W P Greening. Adjuvant chemotherapy for breast cancer: side effects and
quality of life.Br Med J. 1980 December 13; 281(6255): 1594–1597.
8. http://www.palliative.org/PC/ClinicalInfo/AssessmentTools/3C7%20ESAS-r%20guidelines.pdf accessed on 27.06.2011
9. http://groups.eortc.be/qol/questionnaires_qlqc30.htm accessed on 21.06.2011
10. L. Brunton et al. Goodman & Gillman’s The Pharmacological Basis of Therapeutics. 11th edition. Mc Graw Hill Medical
Publishing Division. 2006.
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