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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Canada Royal Enoch Phytomedicine Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2026 to Dec 2027 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Aug 2026 to Aug 30, 2026
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 2 of 32 entries
    • Site details revised
  2. Phase: Phase 2 to Not applicablev6 Show 6 more changesShow less
    • Primary completion date: May 2025 to Dec 2026
    • Start date: May 30, 2023 to Aug 2026
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Jun 2025 to Dec 2026
    • Eligibility criteria shortened, about 21 words
    • Site details revised
  3. Secondary endpoints: details revised at 4 of 32 entriesv5
  4. Primary completion date: May 2024 to May 2025
    • Study completion date: Jun 2024 to Jun 2025
    v4
  5. Study completion date: Aug 2024 to Jun 2024
    • Eligibility criteria shortened, about 9 words
    • Study title shortened, about 5 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2022 to May 30, 2023
    • Study sites: 0 to 1
    • Primary completion date: Mar 2024 to May 2024
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05664009
Lead Sponsor Canada Royal Enoch Phytomedicine Co., Ltd.
Collaborators: KGK Science Inc.
Conditions
(from sponsor)		 Fatigue, Cancer, Treatment-Related
Related terms Fatigue, Neoplasms, Second Primary
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov