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 | Completed Phase 3 DMC

• 1 other identifier: NUVA-BC-III-2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Breast Cancer; Cancer-Related Fatigue; Chemotherapy; Nuvastatic™; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Brief Fatigue Inventory (BFI) score

  The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS).

  At baseline until end of treatment at 12 weeks

Secondary Outcomes (2)

• 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.

  At baseline and end of treatment at 12 weeks

• Changes in biomarkers

  At baseline and end of treatment at 12 weeks

Other Outcomes (1)

• Exploratory biomarker

  at baseline and end of treatment at 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1000mg sachet effervescent powder Placebo (1 sachet X 3 times a day)

Drug: Placebo

Nuvastatic ™

EXPERIMENTAL

1000mg sachet effervescent powder Nuvastatic ™ (1 sachet X 3 times a day)

Drug: Nuvastatic ™

Interventions

Placebo DRUG

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

Placebo

Nuvastatic ™ DRUG

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

Nuvastatic ™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study is only for women who have been diagnosed with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natureceuticals Sdn Bhd: lead

Study Sites (7)

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

Srikakulam, Andhra Pradesh, 532001, India

Location

Hanji Cancer Centre

Belagavi, Karnataka, 590006, India

Location

K.R. Hospital, Mysore Medical College & Research Institute

Mysuru, Karnataka, 570001, India

Location

Onco-Life Cancer Centre

Satara, Maharashtra, 415519, India

Location

Onco-Life Cancer Centre, Pvt. Ltd (Talegaon General Hospital)

Talegaon Dābhāde, Maharashtra, 410506, India

Location

Siddharth Gupta Memorial Cancer Hospital (A Unit of Acharya Vinoba Bhave Rural Hospital)

Wardha, Maharashtra, 442004, India

Location

Avicenna Hospital

Lucknow, Uttar Pradesh, 226016, India

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Design

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: June 25, 2026
• Study Start: June 17, 2025
• Primary Completion: April 25, 2026
• Study Completion: June 15, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

IN (7)