A phase II randomized, double-blind, placebo-controlled study of Nuvastatic (C50SEW505OESA), a standardized rosmarinic acid-rich polymolecular botanical extract formulation to reduce cancer-related fatigue in patients with solid tumors

Ng ML 1 , Majid AMSA 2 , Yee SM 3 , Natesan V 2 , Basheer MKA 2 , Gnanasekaran A 4 Show all authors , Al-Suede FSR 2 , Parish C 5 , Dalal M 6 , Ming LC 7 , Nazari V M 8 , Khan SS 2 , Stn Hameed Sultan SB 8 , Babu KG 9 , Majid ASA 10 , Abdul Aziz MAS 11

Affiliations 

  • 1 Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
  • 2 EMAN Research Ltd, Symonston, Australia
  • 3 Faculty of Pharmacy, SEGi University, Petaling Jaya, Malaysia
  • 4 Department of Pharmacology, Faculty of Medicine, Quest International University, Ipoh, Malaysia
  • 5 College of Health & Medicine, Australian National University, Canberra, Australia
  • 6 Notrox Research Private Limited, Hospital & Health Care Bangalore, Bangalore, Karnataka, India
  • 7 School of Medical and Life Sciences, Sunway University, Sunway City, Malaysia
  • 8 EMAN Biodiscoveries Sdn. Bhd, Sungai Petani, Malaysia
  • 9 HCG Cancer Centre-Double Road, Bengaluru, Karnataka, India
  • 10 Department of Pharmacology, Faculty of Medicine, Quest International University, Ipoh, Malaysia. amanharvard2020@outlook.com
  • 11 Icon Cancer Centre, Island Hospital, George Town, Penang, Malaysia
Support Care Cancer, 2024 May 06;32(6):331.
PMID: 38710920 DOI: 10.1007/s00520-024-08536-w

Abstract

AIM: We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA) in improving cancer-related fatigue (CRF) among cancer patients.

METHODS: This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA).

RESULTS: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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