Breast NeoplasmsPhase 3NuvastaticTMNCT07669506
A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer Undergoing Chemotherapy
A Phase 3 study testing Nuvastatic ™ in people with Breast Neoplasms and Fatigue, run by Natureceuticals Sdn Bhd at 7 sites in India.
Trial summary
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Fatigue, Quality of Life
- What is being tested?
- Nuvastatic ™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 7 sitesIndia
- Study dates
- 17 Jun 2025to 15 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study.
- Confirm diagnosis of Breast cancer as per the available Report.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
- Life expectancy ≥ 6 months, as per Investigator's judgment
- Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deem stable by the investigator can be included in the study
- At screening patient with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
Who cannot join
- Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the Investigator's clinical judgement.
- Patient who have stage IV Disease
- Female patients who are pregnant or breast-feeding.
- Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
- 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.
- Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '
- Patients with planned therapy or treatment with another investigational agent.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Hanji Cancer Centre
Belagavi, Karnataka, 590006
Avicenna Hospital
Lucknow, Uttar Pradesh, 226016
K.R. Hospital, Mysore Medical College & Research Institute
Mysuru, Karnataka, 570001
Onco-Life Cancer Centre
Satara, Maharashtra, 415519
Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital,
Srikakulam, Andhra Pradesh, 532001
Onco-Life Cancer Centre, Pvt. Ltd (Talegaon General Hospital)
Talegaon Dābhāde, Maharashtra, 410506
Siddharth Gupta Memorial Cancer Hospital (A Unit of Acharya Vinoba Bhave Rural Hospital)
Wardha, Maharashtra, 442004
About this study
Official title: 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
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
The main questions it aims to answer are:
Read more
Does Nuvastatic™ reduce cancer-related fatigue as measured by change in the Brief Fatigue Inventory (BFI) from baseline to end of treatment? Does Nuvastatic™ improve quality of life, safety outcomes, and clinical parameters compared with placebo during chemotherapy?
Researchers will compare patients receiving Nuvastatic™ plus standard chemotherapy with patients receiving placebo plus standard chemotherapy to see if Nuvastatic™ leads to greater reductions in fatigue, improved quality of life, and acceptable safety while undergoing treatment.
Participants will:
- Receive Nuvastatic™ or matching placebo as a 1000 mg effervescent sachet taken three times daily after meals for three chemotherapy cycles
- Continue their standard-of-care chemotherapy as prescribed by their treating physician
- Complete fatigue and quality-of-life questionnaires (BFI, SF-36, EORTC QLQ-C30)
- Undergo routine clinical assessments, laboratory tests, ECGs, and safety monitoring
- Undergo CT imaging for tumor response assessment according to RECIST 1.1
- Conditions
- Breast Neoplasms, Fatigue, Quality of Life, Chemotherapy, Adjuvant
- Being tested
- Nuvastatic ™, Placebo
- Keywords
- Breast Cancer, Cancer-Related Fatigue, Chemotherapy, Nuvastatic™, Randomized Controlled Trial
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvastatic ™Drug
Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
PlaceboDrug
greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1000mg sachet effervescent powder Placebo (1 sachet X 3 times a day) Receives: Drug: Placebo |
| Nuvastatic ™ | Experimental | 1000mg sachet effervescent powder Nuvastatic ™ (1 sachet X 3 times a day) Receives: Drug: Nuvastatic ™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Fatigue Inventory (BFI) score
The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS).
Measured: At baseline until end of treatment at 12 weeks
Secondary outcomes (2)
Overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study.
Secondary Outcome Measures are:
Fatigue assessment using SF-36 Questionnaire from screening to EOT. Change in Global Health Status/QoL score as measured by EORTC QLQ-C30 from screening to EOT.
Incidence of adverse events (AEs) graded according to CTCAE v5.0. Tumor response assessed by RECIST 1.1 criteria from baseline to EOT.
Measured: At baseline and end of treatment at 12 weeks
Changes in biomarkers
Change in serum CEA (ng/mL) and CA15-3 (U/mL) levels from screening to EOT. Change in laboratory parameters from screening to EOT.
Measured: At baseline and end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start17 Jun 2025
- Primary completion25 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natureceuticals Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669506
- Sponsor's protocol ID
- NUVA-BC-III-2025
- Acronym
- NuvastaticTM
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07669506
- Acronym / sponsor ID
- NuvastaticTM / NUVA-BC-III-2025
- Conditions
- Breast Neoplasms, Fatigue, Quality of Life, Chemotherapy, Adjuvant
- Keywords
- Breast Cancer, Cancer-Related Fatigue, Chemotherapy, Nuvastatic™, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Natureceuticals Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
The main questions it aims to answer are:
Does Nuvastatic™ reduce cancer-related fatigue as measured by change in the Brief Fatigue Inventory (BFI) from baseline to end of treatment? Does Nuvastatic™ improve quality of life, safety outcomes, and clinical parameters compared with placebo during chemotherapy?
Researchers will compare patients receiving Nuvastatic™ plus standard chemotherapy with patients receiving placebo plus standard chemotherapy to see if Nuvastatic™ leads to greater reductions in fatigue, improved quality of life, and acceptable safety while undergoing treatment.
Participants will:
- Receive Nuvastatic™ or matching placebo as a 1000 mg effervescent sachet taken three times daily after meals for three chemotherapy cycles
- Continue their standard-of-care chemotherapy as prescribed by their treating physician
- Complete fatigue and quality-of-life questionnaires (BFI, SF-36, EORTC QLQ-C30)
- Undergo routine clinical assessments, laboratory tests, ECGs, and safety monitoring
- Undergo CT imaging for tumor response assessment according to RECIST 1.1
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1000mg sachet effervescent powder Placebo (1 sachet X 3 times a day) |
| Nuvastatic ™ | Experimental | Drug: Nuvastatic ™1000mg sachet effervescent powder Nuvastatic ™ (1 sachet X 3 times a day) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study.
- Confirm diagnosis of Breast cancer as per the available Report.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
- Life expectancy ≥ 6 months, as per Investigator's judgment
Key exclusion criteria (8 listed)
- Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the Investigator's clinical judgement.
- Patient who have stage IV Disease
- Female patients who are pregnant or breast-feeding.
- Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvastatic ™Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet | Drug | Nuvastatic ™ |
| Placebogreenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet | Drug | Placebo |
Primary outcome
Change in Brief Fatigue Inventory (BFI) score
Time frame: At baseline until end of treatment at 12 weeks
The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS).
2 secondary outcomes
Overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study.
Time frame: At baseline and end of treatment at 12 weeks
Changes in biomarkers
Time frame: At baseline and end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nuvastatic ™ in people with Breast Neoplasms and Fatigue, run by Natureceuticals Sdn Bhd at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Fatigue Inventory (BFI) score (time frame: At baseline until end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.