| CTRI Number |
CTRI/2025/06/088476 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the effect and Safety of Nuvastatic in Reducing Cancer Related Fatigue in Breast Cancer Patients who are taking Chemotherapy |
|
Scientific Title of Study
|
Phase III Randomized Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NUVA-BC-III-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Chandu Gangadhar Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Room no 01 3rd floor office no 302 303 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
09545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Chandu Gangadhar Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Room no 01 3rd floor office no 302 303 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
09545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chandu Gangadhar Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Room no 01 3rd floor office no 302 303 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
09545817447 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
|
Source of Monetary or Material Support
|
| Natureceuticals Sdn Bhd
A1 1 A1 2 and A1 3 Lot 5 Kedah Halal Park Persiaran 2 by 1 Kawasan Perindustrian 08000 Sungai Petani Kedah Malaysia |
|
|
Primary Sponsor
|
| Name |
Natureceuticals Sdn Bhd |
| Address |
A1 1 A1 2 and A1 3 Lot 5 Kedah Halal Park Persiaran 2 by 1 Kawasan Perindustrian 08000 Sungai Petani Kedah Malaysia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Nandhana |
Asian cancer hospital |
Department of Medical Oncologist Managing Director Asian cancer hospital
Old Day and Night complex
Day and night junction
Srikakulam 532001 A P India
Srikakulam
ANDHRA PRADESH |
9948741133
-
bioexperts21@gmail.com |
| Dr EzhilarasiR |
CHALMEDA ANANDRAO INSTITUTE OF MEDICAL SCIENCE |
Chalmeda Anand Rao Institute of Medical Science Cancer Hospital and Research Institute H no 10 100 by 1 Bommakal Karimnagar Telangana 505001
Karimnagar
TELANGANA |
9440073399
-
ezhil2002@yahoo.com |
| Dr Abhinnadan Mahavir Hanji |
Hanji Cancer Centre |
Ground Floor Consultation Room 1 Hanji Hospital Cancer Care 135 Mangalwar Peth Tilakwadi Belagavi 590006 Karnataka
Belgaum
KARNATAKA |
8747004004
-
drabhinandanhanji@gmail.com |
| Dr Vikas L |
K R hospital Mysore medical college and research Institute |
Room No 01 Jayadeva Block KR Hospital 1st Floor Oncology Ward Opd No 23 Department of Oncology K R Hospital Mysore Medical College and Research Institute irwin road mysore 570001 Mysore KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9663099774
-
vikilaxman@gmail.com |
| Dr Dattatraya Andure |
Onco Life Cancer Centre satara |
Onco Life Cancer Centre
Ground Floor OPD No 2 Survey no 252 A/P Shendre Opp Abhaysinhraje Bhonsle Institute Of Technology Tal and District Satara Maharashtra 415519
Satara
MAHARASHTRA |
7276556028
-
drandureolcccr@gmail.com |
| Dr Gaurav Jaswal |
Onco Life Cancer Centre talegaon |
Onco-Life Cancer Centre Pvt Ltd Talegaon
Ground Floor OPD No 3 Talegaon General Hospital Talegaon Chakan Road Yashwant Nagar Talegaon Dabhade Tal Maval
Pune
MAHARASHTRA |
7009521950
-
drgauravjaswalcr@yahoo.com |
| Dr Abhishek Mahaveer |
Sanjeevini Speciality hospital and Heart Care Center |
Shirur park main road
OPD No 03 Ground floor
Department of Critical care medicine and Oncology
Sanjeevini Speciality hospital and Heart Care Center Vidya nagar Hubli Karnataka 580031
Belgaum
KARNATAKA |
99161 32321
-
abhishekpatil1061@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| CAIMS CANCER HOSPITAL AND RESEARCH INSTITUTE |
Approved |
| Ethics committee sanjeevini speciality Hospital |
Approved |
| Institutional ethics committee great eastern medical school and hospital |
Approved |
| Institutional Ethics Committee Mysore Medical College and Research Institute |
Approved |
| Institutional Ethics Committee Onco Life Cancer |
Approved |
| Institutional Ethics Committee Onco Life Cancer Centre Talegaon |
Approved |
| Lakeview Ethics Committee |
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 |
| Intervention |
NuvastaticTM 1000mg Sachet |
Participants will be asked to consume 1000mg sachet effervescent powder dissolved in 250 ml of water 3 times a day after meal for total 70 days
(1 sachet X 3 times a day) |
| Comparator Agent |
Placebo of Nuvastatic 1000 mg |
Participants will be asked to consume 1000 mg
sachet effervescent powder dissolved in 250 ml of
water 3 times a day after meal for total 70 days (1 sachet X 3 times
a day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 Female Patients aged greater than or equal to 18 years and less than or equal to65 years who are willing to voluntarily provide consent
for participation in the study
2 Confirm diagnosis of Breast cancer as per the available Report
3 Eastern Cooperative Oncology Group performance status of 0 to 2 at Screening
4 The patient has stable haemoglobin greater than or equal to 9 g per dL throughout the screening
5 Life expectancy greater than or equal to 6 months as per Investigator judgment
6 Patients with comorbidities or medical conditions including Type 2 DM hypertension and are deem stable by the investigator can be included in the study
7 At screening patient with stable fatigue has a newly developed fatigue OR worsening of fatigue
scoring as assessed by BFI should be included |
|
| ExclusionCriteria |
| Details |
1 Patients who have any untreated reversible medical condition which may cause fatigue example
major metabolic or electrolyte disturbance active infection endocrine abnormalities as per
the Investigators clinical judgement
2 Patient who have stage IV Disease
3 Female patients who are pregnant or breast-feeding
4 Patients with known hepatitis C virus, hepatitis B virus HIV infection
5 Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough
to interfere with study drug absorption in the opinion of the Investigator
6 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study
7 Patients with planned therapy or treatment with another investigational agent
8 Previous exposure to any investigational agent within 4 weeks prior to screening or planned
administration of an Investigational agent other than as specified by this protocol during the
study period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Change in BFI score |
From Screening to end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Change in serum CEA and CA15-3 levels
2 Fatigues SF 36 questionnaire
3 Change in the laboratory Parameter
4 Change in Global Health Status QoL score as measured by the EORTC QLQ C30
5 Incidence of adverse events graded according to Common Terminology Criteria for
Adverse Events (CTCAE) version 5
6 RECIST 1.1 |
1 From screening to EOT
2 From screening to EOT
3 From screening to EOT
4 From screening to EOT
5 From screening to EOT
6 From screening to End of the study |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2025 |
| Date of Study Completion (India) |
21/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/05/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multi Centre. Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer- Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy. Patients with breast cancer who are receiving or are scheduled to receive standard treatment as per the Investigator. treatment respectively will be eligible for enrolment in the study. Patients should be scheduled to receive atvleast 3 chemotherapy cycles 3-weekly (21 days), as per the Investigator’s judgment and standard of care. The screening period will last up to 14 days (Day 0) prior to Cycle 1. Prior to enrolment in the study on Day 1 (Cycle 1), patients will be re-evaluated for inclusion criteria. The dosing and duration for standard chemotherapy will be at the Investigator’s discretion and standard of care of study center. A 3-weekly (21 days) cycle is assumed but can vary based on the patient’s requirements and as deemed necessary by the Investigator. The patient will be evaluated for additional chemotherapy cycles as per the study treatment period. After the completion of the treatment cycles, an end-of-treatment (EOT) assessment will be performed at the end of the last Cycle. Dosage & Administration: Test Arm:NuvastaticTM 1000mg Sachet. 1 Sachet of NuvastaticTM 1000mg will be consumed by the Subject 3 times a day for a period of 3 Cycles for total 63-70 days including window period. Reference Arm: Placebo of NuvastaticTM 1000mg Sachet. 1 Sachet of placebo of NuvastaticTM 1000mg will be consumed by the Subject 3 times a day for a period of 3 Cycles for total 63-70 days including window period |