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Supportive Care in Cancer
Published in: Supportive Care in Cancer 6/2024

01-06-2024 | Cancer Fatigue | Research

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

Authors: Mei Ling Ng, Amin Malik Shah Abdul Majid, Siew Mei Yee, V. Natesan, Mohamed Khadeer Ahamed Basheer, Ashok Gnanasekaran, Fouad Saleih Resq Al-Suede, Christopher Parish, Meena Dalal, Long Chiau Ming, Mansoureh Nazari V, Shamsuddin Sultan Khan, Siti Balkees STN Hameed Sultan, K Govind Babu, Aman Shah Abdul Majid, Mohamed Amir Shah Abdul Aziz

Published in: Supportive Care in Cancer | Issue 6/2024

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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 < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen’s d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%).

Conclusion

Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials.

Trial registration

ClinicalTrial.gov ID: NCT04546607. Study registration date (first submitted): 11–05-2020.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Mei Ling Ng
Amin Malik Shah Abdul Majid
Siew Mei Yee
V. Natesan
Mohamed Khadeer Ahamed Basheer
Ashok Gnanasekaran
Fouad Saleih Resq Al-Suede
Christopher Parish
Meena Dalal
Long Chiau Ming
Mansoureh Nazari V
Shamsuddin Sultan Khan
Siti Balkees STN Hameed Sultan
K Govind Babu
Aman Shah Abdul Majid
Mohamed Amir Shah Abdul Aziz
Publication date
01-06-2024
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 6/2024
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-024-08536-w

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