The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults Who Have Received Cancer Treatment

Inclusion Criteria: Males and females between 18 and 65 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, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. 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 control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening Individuals who have completed cancer treatment (radiation, chemotherapy, immunotherapy, target therapy, surgery) but not within two months prior to baseline and not scheduled for further treatment during the study period. Select patient populations on stable baseline therapy may be included at the discretion of the QI. Individuals with CRF defined as a score of ≥4 on the CRF Single-Item Scale (an 11-point scale where 0 is "no fatigue" and 10 is "as bad as it can be") CRF present for at least one month prior to screening Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2 Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period Provided voluntary, written, informed consent to participate in the study Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer history Exclusion Criteria: 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) Individuals with unstable medical conditions as assessed by the QI Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders Individuals with >7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months Major non-cancer surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI Current use of prescription/OTC medications and/or supplements and food/drinks which may affect the efficacy and/ or safety of the IP (see Sections 7.3.1 and 7.3.2) Alcohol or drug abuse within the last 12 months 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 to stop cannabis use for study period Clinically significant abnormal laboratory results at screening as assessed by the QI Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI Individuals who are unable to give informed consent Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant