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Completed

NCT Number: NCT07669506

A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer 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:

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital,, Srikakulam, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

Nuvastatic ™

Drug

Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet

Placebo

Drug

greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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.

  2. Changes in biomarkers

    Time frame: At baseline and end of treatment at 12 weeks

    Change in serum CEA (ng/mL) and CA15-3 (U/mL) levels from screening to EOT. Change in laboratory parameters from screening to EOT.

Other outcomes

  1. Exploratory biomarker

    Time frame: at baseline and end of treatment at 12 weeks

    To investigate whether urinary F2-isoprostane (F2-IsoP) excretion correlates with the severity of cancer-related fatigue (CRF) in patients undergoing chemotherapy

Sponsors and collaborators

Lead sponsor

Natureceuticals Sdn Bhd

Industry

Registry information

Official study 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

Acronym: NuvastaticTM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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