| CTRI Number |
CTRI/2024/07/070026 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Multi-parametric profiling of cancer patient samples and metronomic chemotherapy for forensic and treatment outcomes. |
|
Scientific Title of Study
|
Clinical evaluation of effect of metronomic chemotherapy in cachexia associated with triple negative breast cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Bhoomika Patel |
| Designation |
Associate Professor and Associate Dean |
| Affiliation |
Associate Professor and Associate Dean |
| Address |
Room No. 109, School of Medico-leagal studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat.
Ahmadabad
GUJARAT
382007
India |
| Phone |
9898308973 |
| Fax |
|
| Email |
bhoomika.patel@nfsu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhoomika Patel |
| Designation |
Associate Professor and Associate Dean |
| Affiliation |
National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat |
| Address |
Room No. 109, School of Medico-legal studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat.
Gandhinagar
GUJARAT
382007
India |
| Phone |
9898308973 |
| Fax |
|
| Email |
bhoomika.patel@nfsu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhoomika Patel |
| Designation |
Associate Professor and Associate Dean |
| Affiliation |
National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat |
| Address |
Room No. 109, School of Medico-legal studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat.
Gandhinagar
GUJARAT
382007
India |
| Phone |
9898308973 |
| Fax |
|
| Email |
bhoomika.patel@nfsu.ac.in |
|
|
Source of Monetary or Material Support
|
| Gujarat State Biotechnology Mission (GSBTM), department of science and technology, Govt. of Gujarat. |
| National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhoomika Patel |
Hemato-oncology Clinic (A) Pvt Ltd, HOC Vedanta, Ahmedabad |
Research wing, Besides Occura Eye Hospital/ Pandit Dindayal
Auditorium, Behind Rajpath Club, Off SG Road, Ahmedabad -
380054.
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
| Dr Bhoomika Patel |
Hemato-oncology Clinic (A) Pvt Ltd, HOC Vedanta, Ahmedabad |
1st Floor, Stadium Commerce College Road, Navrangpura, Ahmedabad, 380009, Gujarat.
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
| Dr Bhoomika Patel |
Hemato-oncology Clinic (A) Pvt Ltd, HOC Vedanta, Ahmedabad |
4th Floor, Rudra commercial Complex Opp. Sankalp Restaurant,
Maninagar, Ahmedabad, 380038, Gujarat
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
| Dr Bhoomika Patel |
Oncowell Cancer Hospital |
3rd floor, Center Plaza Satadhar Cross Road, Road, Sola, Ahmedabad, Gujarat, 380061.
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
| Dr Bhoomika Patel |
Shaleen Hospital Multispeciality |
Shaleen Plaza, 4th & 5th Floor Shaleen Plaza, Sola Gam Rd, near Mangaldeep Party Plot, Ahmedabad, Gujarat, 380060
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
| Dr Bhoomika Patel |
Shubahm cancer centre |
1st floor, near Sola Over Bridge, Hetabpur Road, to, Zydus Hospital Rd, opp. Zydus Hospital, Thaltej, Ahmedabad, Gujarat 380059
Ahmadabad
GUJARAT |
9898308973
bhoomika.patel@nfsu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat, 382007 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chemotherapy |
For comparator group, standard chemotherapeutic drugs will be given to TNBC patients the dose, frequency and duration of which will be as per oncologists discretion. The route of administration for chemotherapeutic drugs will be intravenous. |
| Intervention |
Metronomic chemotherapy |
Name and dose of the drug: MCT Cyclophosphamide (CTX) (50-1000mg) +/- Methotrexate (2.5-100mg), MCT Capecitabine (CAPE) (50-1000mg).
The range of the drugs is mentioned as the actual dose is decided by the oncologist based on the condition of the patient.
Route of administration: Oral
Frequency and total duration of such intervention: As per oncologists discretion.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1) Female patients with age more than equal to 18 years and less than equal to 80 years.
2) Patients with confirmed TNBC from pathological reports, previously treated or not with other drugs for the metastatic disease.
3) Patients with more than equal to 1 measurable lesion according to RECIST 1.1 criteria, ECOG score less than equal to 2 and life expectancy of more than equal to 16 weeks.
4) Patients with adequate bone marrow, hepatic, and renal functions, indicated by haemoglobin more than equal to 10g per L, absolute neutrophil count more than equal to 1.5 billion neutrophils per liter of blood, platelet count more than equal to 100 billion platelets per liter of blood, total serum bilirubin less than 1.5 of upper normal limit (UNL), AST/ALT less than 2.5 of UNL, (less than 3.5 of UNL for liver metastases), or alkaline phosphatase less than 2.5 of UNL (less than 5 of UNL for bone/liver metastases).
5) Evidence of cachexia as judged by one of:
a. More than equal to 5 percent of documented weight loss in the previous 6 months.
b. A subjective report of weight loss in the previous 6 months and a recorded BMI less than 20 kilograms per square meter.
c. Ongoing documented weight loss of at least 1 kg in the week prior to day 0; or 1.25 kg in the 2 weeks prior to day 0, or 1.5 kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25 kilograms per square meter.
|
|
| ExclusionCriteria |
| Details |
1) Patients not ready to provide written informed consent.
2) Patient with other severe co-morbidities like renal or hepatic complications, cardiac disease, uncontrolled diabetes or hypercalcemia, severe peripheral neuropathy, active infection, or previous organ allograft.
3) Patients with history of another malignancy.
4) Patients unable to swallow pills or gastrointestinal conditions that might predispose to drug intolerability or poor drug absorption.
5) Pregnant or lactating women.
6) Patients with history of hypersensitivity to any of the regimen to be used in capecitabine, methotrexate and cyclophosphamide.
7) Women who had participated in another clinical trial with any investigational drug within 30 days before study inclusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome No. 1- Body mass and body composition parameters
Outcome No. 2- Performance tests
Outcome No. 3- Inflammatory markers
Outcome No. 4- Markers of carbohydrate metabolism
Outcome No. 5- Markers of lipid metabolism
Outcome No. 6- Skeletal muscle wasting parameters
|
Baseline and at the end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome No. 1- Progression Free Survival (PFS), Overall Survival (OS).
Outcome No. 2- Adverse Events (AEs)
Outcome No. 3- QoL Assessment
Outcome No. 4- Nutritional Screening
Outcome No. 5- To study the allelic imbalance from blood/ tissues of TNBC patients.
|
Outcome No. 1, 2, 3, 4- Baseline and at the end of the study.
Outcome No. 5- No time point is applicable. |
|
|
Target Sample Size
|
Total Sample Size="254"
Sample Size from India="254"
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)
|
06/06/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhoomika.patel@nfsu.ac.in].
- For how long will this data be available start date provided 01-06-2024 and end date provided 31-05-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is non-randomized, open label and parallel arm study comparing the safety and efficacy of metronomic chemotherapy over chemotherapy in patients suffering from cachexia associated with triple negative breast cancer in India. Patients will be recruited based on the inclusion and exclusion criteria and also dependent upon financial feasibility. Informed consent of the participants will be taken through ICF. Blood/ tissue samples of the patients suffering from TNBC will be collected. The primary outcome will measure parameters related to cachexia such as body mass and composition parameters, performance tests, inflammatory markers, markers of carbohydrate metabolism, markers of lipid metabolism, skeletal muscle wasting parameters. The secondary outcomes will be tumor progression, adverse events, quality of life and nutritional assessment questionnaire. Apart from this, allelic imbalance in small cohort samples will also be performed. |