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

Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Females not of child-bearing potential, defined as those who have undergone asterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tuballigation, complete endometrial ablation) or have been post-menopausal for at least 1year prior to screening Or, Females of child-bearing potential must have a negative baseline urine pregnancy testand agree to use a medically approved method of birth control for the duration of thestudy. All hormonal birth control must have been in use for a minimum of three months.Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changingto heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening

3. Individuals previously diagnosed with cancer and have CRF defined as a score of ≥4 onthe CRF Single-Item Scale (an 11-point scale where 0 is "no fatigue" and 10 is "as badas it can be")
4. CRF present for at least one month prior to screening
5. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2
6. Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening
7. Agrees to maintain current lifestyle habits as much as possible throughout the studydepending on ability to maintain the following: diet, medications, supplements,exercise, and sleep and avoid taking new supplements during the study period
8. Provided voluntary, written, informed consent to participate in the study
9. Otherwise healthy as determined by medical history and laboratory results as assessedby Qualified Investigator (QI) while taking into consideration the participant's cancerhistory

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study
2. Allergy, sensitivity, or intolerance to the investigational product's or placebo'sactive or inactive ingredients
3. Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptorpositive breast cancer
4. 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)
5. Individuals with unstable medical conditions as assessed by the QI
6. Individuals with current untreated/uncontrolled high blood pressure ortachycardia/heart rhythm disorders
7. Individuals with >7.5% HbA1c with treatment for high blood sugar/diabetes orindividuals with ≥6.5% HbA1c without treatment
8. Significant cardiovascular event in the past 6 months. Participants with nosignificant cardiovascular event on stable medication may be included after assessmentby the QI on a case-by-case basis
9. History of or current diagnosis with kidney and/or liver diseases as assessed by theQI on a case-by-case basis, with the exception of history of kidney stones inparticipants who are symptom free for 6 months
10. Major non-cancer surgery in the past 3 months or individuals who have planned surgeryduring the course of the study. Participants with minor surgery will be considered ona case-by-case basis by the QI
11. Current use of prescription/OTC medications and/or supplements and food/drinks whichmay affect the efficacy and/ or safety of the IP (see Sections 7.3.1 and 7.3.2)
12. Alcohol or drug abuse within the last 12 months
13. Frequent (daily) and chronic cannabis users. Occasional (e.g., once per month)cannabis users may be included at the discretion of the QI and if eligible, asked tostop cannabis use for study period
14. Clinically significant abnormal laboratory results at screening as assessed by the QI
15. Participation in other clinical research studies 30 days prior to baseline, asassessed by the QI
16. Individuals who are unable to give informed consent
17. Any other condition or lifestyle factor, that, in the opinion of the QI, may adverselyaffect the participant's ability to complete the study or its measures or posesignificant risk to the participant
18. Individuals who are on active cancer treatment (e.g., radiation, chemotherapy,immunotherapy, target therapy), have completed cancer treatment within one month ofbaseline, and/or are scheduled to receive further treatment during the study period.