Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer (NuvastaticTM)

23. august 2026 oppdatert av: Natureceuticals Sdn Bhd

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:

  • 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

250

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • India
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • Rekruttering
        • Omega Hospital Chinna Gadhili
        • Ta kontakt med:
          • Dr Bella Ravi Shankar
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • Aktiv, ikke rekrutterende
        • K R Hospital
    • Maharashtra
      • Jalgaon, Maharashtra, India, 425001
        • Aktiv, ikke rekrutterende
        • Jeevanjyoti Cancer Hospital
    • Mahrasta
      • Pune, Mahrasta, India, 411027
        • Rekruttering
        • Sangavi Multispeciality Hospital Pvt. Ltd,
        • Ta kontakt med:
          • Dr. Nikhil Mallinath Shirsi
    • Tamil Nadu
      • Erode, Tamil Nadu, India, 638012
        • Rekruttering
        • Erode Cancer Care Centre
        • Ta kontakt med:
          • Dr. K. Velavan
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India
        • Aktiv, ikke rekrutterende
        • International Oncology Cancer Tower 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Placebo kapsel
Legemiddel: Placebo
300mg capsule, (3 capsules X 3 times a day)
Eksperimentell: Nuvastatic 300
Nuvastatic™ 300 capsule
Legemiddel: Nuvastatic 300
300mg capsule, (3 capsules X 3 times a day)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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 Visual Analogue Fatigue Scale (VAFS).
From Screening to EOT (about 6 months)
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 the study (about 6 months)
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.
At baseline and at end of the study (about 6 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Natureceuticals Sdn Bhd

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2025

Primær fullføring (Antatt)

30. oktober 2026

Studiet fullført (Antatt)

30. oktober 2026

Datoer for studieregistrering

Først innsendt

7. januar 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EBCT003
  • NatureCeuticals Sdn Bhd (Annet stipend/finansieringsnummer: NatureCeuticals Sdn Bhd)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere