The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanada Royal Enoch Phytomedicine Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
Males and females ≥18 years of age
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients
Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancer
Individuals with other primary causes of fatigue, as assessed by the QI (e.g., diagnosed non-cancer related chronic pain, insomnia/sleep disorders, depression/psychiatric disorders, unstable hypothyroidism, diabetes, gastrointestinal disease or symptoms that can affect nutritional balance)
Trial design
Treatments tested in this trial
- Redsenol-1 Plus
- Placebo
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Canada Royal Enoch Phytomedicine Co., Ltd.
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov