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

NCT07669506 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-25

No results posted yet for this study

Summary

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

Conditions

  • Breast Neoplasms
  • Fatigue
  • Quality of Life
  • Chemotherapy, Adjuvant

Interventions

DRUG

Nuvastatic ™

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Natureceuticals Sdn Bhd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2026-04-25
Completion
2026-06-15

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669506 on ClinicalTrials.gov