The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Redsenol-1 Plus
Dietary supplementTwo capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
Placebo
Other interventionTwo capsules of Placebo will be taken three times per day for 12 weeks (84 days).
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Redsenol-1 PlusExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in the severity of cancer-related fatigue from baseline to week 12.
The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Time frame
baseline and 84 daysSecondary outcomes
1
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8 as assessed by the FACIT-F fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Time frame
baseline, 28 days, 56 days2
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F total score.
Time frame
baseline, 28 days, 56 days, 84 days3
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F physical well-being (PWB) sub-scale.
Time frame
baseline, 28 days, 56 days, 84 days4
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the social well-being (SWB) sub-scale.
Time frame
baseline, 28 days, 56 days, 84 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Canada Royal Enoch Phytomedicine Co., Ltd.
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov