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 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
250
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Aman Shah Abdul Majid, MBChB, DPhil
- Telefonnummer: +605-2490500
- E-mail: amanharvard2020@outlook.com
Studiesteder
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, Indien, 530040
- Rekruttering
- Omega Hospital Chinna Gadhili
-
Kontakt:
- Dr Bella Ravi Shankar
-
-
Karnataka
-
Mysore, Karnataka, Indien, 570001
- Rekruttering
- K R Hospital
-
Kontakt:
- Dr. Vikas L
-
-
Maharashtra
-
Jalgaon, Maharashtra, Indien, 425001
- Rekruttering
- Jeevanjyoti Cancer Hospital
-
Kontakt:
- Dr. Chaudhari Nitin Laxman
-
Pune, Maharashtra, Indien, 411027
- Rekruttering
- Sangavi Multispeciality Hospital Pvt. Ltd,
-
Kontakt:
- Dr. Nikhil Mallinath Shirsi
-
-
Tamil Nadu
-
Erode, Tamil Nadu, Indien, 638012
- Rekruttering
- Erode Cancer Care Centre
-
Kontakt:
- Dr. K. Velavan
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, Indien
- Rekruttering
- International Oncology Cancer Tower 1
-
Kontakt:
- Dr. Sachin Anand Prakash
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo kapsel
|
300mg capsule, (3 capsules X 3 times a day)
|
|
Eksperimentel: Nuvastatic 300
Nuvastatic™ 300 capsule
|
300mg capsule, (3 capsules X 3 times a day)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Tidsramme: 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.
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall QoL and functional improvement
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2025
Primær færdiggørelse (Anslået)
31. oktober 2026
Studieafslutning (Anslået)
30. november 2026
Datoer for studieregistrering
Først indsendt
8. januar 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
25. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EBCT004
- NatureCeuticals Sdn Bhd (Andet bevillings-/finansieringsnummer: NatureCeuticals Sdn Bhd)
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