| CTRI Number |
CTRI/2025/02/079984 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study how prakriti is linked with the outcomes of early and locally advanced breast cancer |
|
Scientific Title of Study
|
Study of association between prakriti and outcomes of early and locally advanced breast
cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4375 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Gota |
| Designation |
Professor and OIC- Department of Clinical Pharmacology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
KS 102, ACTREC, TMC, Sector 22, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405493 |
| Fax |
|
| Email |
vikramgota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manohar Gundeti |
| Designation |
Research Officer |
| Affiliation |
RRAP, Central Ayurveda Research Institute, Mumbai |
| Address |
1st floor, CCRAS, CARI Building, Technical division, Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9004960133 |
| Fax |
|
| Email |
drmanoharccras@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manohar Gundeti |
| Designation |
Research Officer |
| Affiliation |
RRAP, Central Ayurveda Research Institute, Mumbai |
| Address |
1st floor, CCRAS, CARI Building, Technical division, Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9004960133 |
| Fax |
|
| Email |
drmanoharccras@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRAS, Ministry of AYUSH
61-65, opp.D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, 110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS- Ministry of AYUSH |
| Address |
61-65, opp.D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikram Gota |
ACTREC, TMC |
KS-102, ACTREC, Sector 22, Utsav Chowk CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA |
02227405493
vikramgota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C509||Malignant neoplasm of breast of unspecified site. Ayurveda Condition: PRAKRUTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
A.) Inclusion criteria for cancer patients for Prakriti assessment-
1. Adult females of age 18 years to 65 years
2. Patients who will receive AC or EC and paclitaxel chemotherapy as adjuvant or
neoadjuvant therapy for breast cancer.
3. All subtypes of breast cancer (hormone receptor positive, TNBC and HER 2
positive disease)
4. ECOG PS 0 to 2
5. Adequate organ function
6. Patient willing to give written informed consent
B.) Inclusion criteria for cancer patients for microbiome study:
1. Adult females of age 40 years to 65 years
2. Patients who will receive AC or EC and paclitaxel chemotherapy as adjuvant or
neoadjuvant therapy for breast cancer
3. All subtypes of breast cancer (hormone receptor positive, TNBC and HER 2
positive disease
4. ECOG PS 0-2
5. Adequate organ function
6. Patient willing to give written informed consent
C.) Inclusion criteria for healthy volunteers:
1. Apparently healthy adult females of age 40 years to 65 years
2. Willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
A.) Exclusion criteria for cancer patients:
1. Metastatic breast cancer
2. Patients suffering from psychological illness or taking medicine for psychological illness
B.) Exclusion criteria for cancer patients for microbiome study:
1. Metastatic breast cancer
2. History of severe gut disease (Malabsorption syndromes such as coeliac sprue, undergone gut resection) or other uncontrollable gastrointestinal conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)
3. Patients who were administered antibiotics/antivirals/antifungals for more than
10 days in the preceding 1 month of enrolment into the study
4. Patients who have recently used probiotics or laxatives (within 1 months)
5. Diabetic patients who are on oral Metformin will be excluded
6. Patients suffering from psychological illness or taking medicine for
psychological illness
C.) Exclusion criteria for healthy volunteers:
1. History of severe gut disease (Malabsorption syndromes such as coeliac sprue, undergone gut resection) or other uncontrollable gastrointestinal conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)
2. Administered antibiotics/antivirals/antifungals for more than 10 days in the preceding 1 month of enrolment into the study
3. Recently used probiotics or laxatives (within 1 month)
4. Diabetic patients who are on oral Metformin will be excluded
5. Patients suffering from psychological illness or taking medicine for psychological illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between Prakriti and systemic therapy-related adverse events in early and locally advanced (non- metastatic) breast cancer patients |
Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the prognostic significance of prakriti in early and locally advanced breast cancer patients |
Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. |
To study the association between prakriti and quality of life during the course of systemic therapy for early and locally advanced breast cancer patients
|
Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. |
| To study the interaction between prakriti, gut microbiome and metabolome. |
Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. |
| Identify predictors of overall toxicity and survival outcomes |
Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chemotherapeutic drugs have been widely used in the treatment of breast cancer. Ayurveda defines that each person has a unique body constitution and has unique type of Prakriti. Can Ayurveda help us understand the correlation between variable outcomes of chemotherapeutics in different patients. Currently, there are only a handful of studies with respect to prakriti in the cancer domain; one case-control study of prakriti assessment in cancer patients is ongoing at TMH and CARI, where prakriti is being assessed in ovarian and cervical cancer patients along with healthy volunteers to study the association. In addition, recent studies also suggest that the composition of gut microbiome gets altered during various disease or treatment modalities, which govern the treatment outcomes. With this background information on the variable effects of chemotherapeutic drugs on different individuals due to genetic differences, the relationship between prakriti, the gut microbiome of an individual, and the correlation between individual gut microbiome composition and chemotherapeutic drug metabolism, it is logical to assess the correlation between prakriti and the effect of chemotherapy on systemic metabolomics and gut microbiome composition. The study aims to integrate the two medical sciences and analyze the connection between them using modern evidence-based scientific tools that may help determine personalized treatment regimens and pharmacodynamics and pharmacokinetics. Prakriti-based treatments may thus help change the existing healthcare situation.
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