Can a supplement beat cancer fatigue? new trial aims to find out
NCT ID NCT05664009
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a dietary supplement called Redsenol-1 Plus can safely reduce fatigue in adults who have had cancer treatment. 72 participants will take either the supplement or a placebo for 12 weeks. The main goal is to see if fatigue levels improve, as measured by a standard questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Redsenol-1 Plus (dietary supplement)
- What this could lead to
- If it works, this could offer a natural option to help reduce fatigue in cancer patients.
- What could go wrong
- This is a small, early-stage trial with no phase designation, so results may not be conclusive. The supplement may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females ≥18 years of age 2. 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 3. 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") 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 study depending 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 assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer history Exclusion Criteria: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients 3. Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive 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, gastrointestinal disease or symptoms that can affect nutritional balance) 5. Individuals with unstable medical conditions as assessed by the QI 6. Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders 7. Individuals with \>7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment 8. 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 9. 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 10. 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 11. 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 5.4.1 and 5.4.2) 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 to stop cannabis use for study period 14. Clinically significant abnormal laboratory results inclusive of thyroid stimulating hormone at screening as assessed by the QI 15. Participation in other clinical research studies 30 days prior to baseline, as assessed 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 adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KGK Science Inc.
London, Ontario, N6B 3L1, Canada
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