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

NCT05664009 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-04-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Canada Royal Enoch Phytomedicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664009 on ClinicalTrials.gov