NCT05664009

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

Conditions

• Fatigue
• Cancer, Treatment-Related

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Redsenol-1 Plus	Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
OTHER	Placebo	Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2022-12-23
• Last updated: 2024-04-05

Locations

1 site across 1 country: Canada