Fatigue Related to Cancer TreatmentPhase 3NuvastaticTMNCT07669467
Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
A Phase 3 study testing Nuvastatic 300 in people with Fatigue Related to Cancer Treatment and Breast Cancer, run by Natureceuticals Sdn Bhd at 6 sites in India.
Trial summary
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fatigue Related to Cancer Treatment, Breast Cancer
- What is being tested?
- Nuvastatic 300
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 6 sitesIndia
- Study dates
- 1 Oct 2025to 30 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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.
- Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
- Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
- Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
- The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
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- Life expectancy ≥ 6 months, as per the investigator's judgment.
- Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.
- At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (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 judgment.
- Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) involvement.
- Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.
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- Female patients who are pregnant or breastfeeding.
- 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 known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
- 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 3 recruiting
- Recruiting
Erode Cancer Care Centre
Erode, Tamil Nadu, 638012
Dr. K. Velavan
- Active, not recruiting
Jeevanjyoti Cancer Hospital
Jalgaon, Maharashtra, 425001
- Active, not recruiting
International Oncology Cancer Tower 1
Kanpur, Uttar Pradesh
- Active, not recruiting
K R Hospital
Mysore, Karnataka, 570001
- Recruiting
Sangavi Multispeciality Hospital Pvt. Ltd,
Pune, Mahrasta, 411027
Dr. Nikhil Mallinath Shirsi
- Recruiting
Omega Hospital Chinna Gadhili
Visakhapatnam, Andhra Pradesh, 530040
Dr Bella Ravi Shankar
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
The main questions it aims to answer are:
Read more
- Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?
- Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
- Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total ~60 treatment days).
- Continue their standard first-line chemotherapy regimen.
- Provide blood sample assessments at Screening and End of Treatment.
- Complete patient diaries and fatigue assessments as per protocol.
- Conditions
- Fatigue Related to Cancer Treatment, Breast Cancer
- Being tested
- Nuvastatic 300, Placebo
- Keywords
- Nuvastatic, Breast Cancer, Cancer related fatigue, Randomized double blind placebo controlled trail, First-Line Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvastatic 300Drug
300mg capsule, (3 capsules X 3 times a day)
PlaceboDrug
300mg capsule, (3 capsules X 3 times a day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
| Nuvastatic 300 | Experimental | Nuvastatic™ 300 capsule Receives: Drug: Nuvastatic 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale.
Measured: From Screening to EOT (about 6 months)
Secondary outcomes (3)
Overall QoL and functional improvement
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
Measured: at baseline and at end of the study (about 6 months)
Overall QoL and functional improvement
The secondary outcome measure is the overall QoL improvement using the ECOG scores that will be compared at baseline and at end of the study.
Measured: At baseline and at end of the study (about 6 months)
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS).
Measured: From Screening to EOT (about 6 months)
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 start1 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Related to Cancer TreatmentStudies 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 study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natureceuticals Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669467
- Sponsor's protocol ID
- EBCT003
- Other IDs
- NatureCeuticals Sdn Bhd
- Acronym
- NuvastaticTM
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT07669467
- Acronym / sponsor ID
- NuvastaticTM / EBCT003
- Conditions
- Fatigue Related to Cancer Treatment, Breast Cancer
- Keywords
- Nuvastatic, Breast Cancer, Cancer related fatigue, Randomized double blind placebo controlled trail, First-Line Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Natureceuticals Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- 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 evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
The main questions it aims to answer are:
- Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?
- Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
- Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total ~60 treatment days).
- Continue their standard first-line chemotherapy regimen.
- Provide blood sample assessments at Screening and End of Treatment.
- Complete patient diaries and fatigue assessments as per protocol.
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 study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
| Nuvastatic 300 | Experimental | Drug: Nuvastatic 300Nuvastatic™ 300 capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.
- Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
- Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
- Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
Key exclusion criteria (13 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 judgment.
- Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) involvement.
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 300300mg capsule, (3 capsules X 3 times a day) | Drug | Nuvastatic 300 |
| Placebo300mg capsule, (3 capsules X 3 times a day) | Drug | Placebo |
Primary outcome
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time frame: From Screening to EOT (about 6 months)
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale.
3 secondary outcomes
Overall QoL and functional improvement
Time frame: at baseline and at end of the study (about 6 months)
Overall QoL and functional improvement
Time frame: At baseline and at end of the study (about 6 months)
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time frame: From Screening to EOT (about 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
6 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 300 in people with Fatigue Related to Cancer Treatment and Breast Cancer, run by Natureceuticals Sdn Bhd at 6 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aman Shah Abdul Majid, MBChB, DPhil (+605-2490500, amanharvard2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. (time frame: From Screening to EOT (about 6 months)). 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 Aug 2026.