A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy. (NuvastaticTM)
22 juni 2026 bijgewerkt door: Natureceuticals Sdn Bhd
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total ~120 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
250
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Aman Shah Abdul Majid, MBChB, DPhil
- Telefoonnummer: +605-2490500
- E-mail: amanharvard2020@outlook.com
Studie Locaties
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, Indië, 530040
- Werving
- Omega Hospital Chinna Gadhili
-
Contact:
- Dr Bella Ravi Shankar
-
-
Karnataka
-
Mysore, Karnataka, Indië, 570001
- Werving
- K R Hospital
-
Contact:
- Dr. Vikas L
-
-
Maharashtra
-
Jalgaon, Maharashtra, Indië, 425001
- Werving
- Jeevanjyoti Cancer Hospital
-
Contact:
- Dr. Chaudhari Nitin Laxman
-
Pune, Maharashtra, Indië, 411027
- Werving
- Sangavi Multispeciality Hospital Pvt. Ltd,
-
Contact:
- Dr. Nikhil Mallinath Shirsi
-
-
Tamil Nadu
-
Erode, Tamil Nadu, Indië, 638012
- Werving
- Erode Cancer Care Centre
-
Contact:
- Dr. K. Velavan
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, Indië
- Werving
- International Oncology Cancer Tower 1
-
Contact:
- Dr. Sachin Anand Prakash
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Male and female patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.
- Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.
- Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.
- Patients must have at least one tumor 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.
- Life expectancy ≥ 6 months, as per investigator's judgment.
- The patient has stable hemoglobin (≥ 9 g/dL)throughout the screening.
- Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study.
Exclusion Criteria:
- Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, 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., EORTC QLQ-C30, BFI, SF-36 and VAS-F.
- 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) are involved by metastatic cancer.
- 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.
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
Placebo-capsule
|
300mg capsule, (3 capsules X 3 times a day)
|
|
Experimenteel: Nuvastatic 300
Nuvastatic™ 300 capsule
|
300mg capsule, (3 capsules X 3 times a day)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Tijdsspanne: From Screening to EOT (about 6 months)
|
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale
|
From Screening to EOT (about 6 months)
|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Tijdsspanne: From Screening to EOT (about 6 months)
|
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS)
|
From Screening to EOT (about 6 months)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall QoL and functional improvement
Tijdsspanne: at baseline and at end of the study (about 6 months)
|
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
|
at baseline and at end of the study (about 6 months)
|
|
Overall QoL and functional Improvement
Tijdsspanne: At baseline and at end of treatment (about 6 months)
|
ECOG scores will be compared at baseline and at end of the study.
|
At baseline and at end of treatment (about 6 months)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2025
Primaire voltooiing (Geschat)
31 oktober 2026
Studie voltooiing (Geschat)
30 november 2026
Studieregistratiedata
Eerst ingediend
8 januari 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2026
Eerst geplaatst (Werkelijk)
25 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EBCT004
- NatureCeuticals Sdn Bhd (Ander subsidie-/financieringsnummer: NatureCeuticals Sdn Bhd)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .