Spots Global Cancer Trial Database for The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
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Trial Identification
Brief Title: The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
Official Title: 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
Study ID: NCT05664009
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
KGK Science Inc., London, Ontario, Canada
Contact Details
Name: David Crowley, MD
Affiliation: KGK Science Inc.
Role: PRINCIPAL_INVESTIGATOR
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