Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
CCRAS- Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the association between Prakriti and systemic therapy-related adverse events in early and locally advanced (non- metastatic) breast cancer patientsTimepoint: Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the prognostic significance of prakriti in early and locally advanced breast cancer patientsTimepoint: 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 Timepoint: 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.Timepoint: 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 outcomesTimepoint: Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle. | — |
Countries
India
Contacts
Public ContactDr Manohar Gundeti
RRAP, Central Ayurveda Research Institute, Mumbai
Outcome results
None listed