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

The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults who have received cancer treatment. 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).

Inclusion Criteria:Males and females between 18 and 65 years of ageFemales 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 screeningOr,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 methodIntrauterine devicesNon-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)Vasectomy of partner at least 6 months prior to screeningIndividuals 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 screeningEastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screeningAgrees 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 periodProvided voluntary, written, informed consent to participate in the studyOtherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer historyExclusion Criteria:Individuals who are pregnant, breast feeding, or planning to become pregnant during the studyAllergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredientsIndividuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancerIndividuals 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 QIIndividuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disordersIndividuals with >7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatmentSignificant 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 basisHistory 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 monthsMajor 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 QICurrent 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 monthsFrequent (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 periodClinically significant abnormal laboratory results at screening as assessed by the QIParticipation in other clinical research studies 30 days prior to baseline, as assessed by the QIIndividuals who are unable to give informed consentAny 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