The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults (NCT05664009) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
Canada72 participantsStarted 2026-08
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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,
. Individuals previously diagnosed with cancer and have 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change in the severity of cancer-related fatigue from baseline to week 12.
. 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
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, gastrointestinal disease or symptoms that can affect nutritional balance)
. 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