FatigueNCT05664009
The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
A study testing Redsenol-1 Plus in people with Fatigue and Cancer, Treatment-Related, run by Canada Royal Enoch Phytomedicine Co., Ltd. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Cancer, Treatment-Related
- What is being tested?
- Redsenol-1 Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- 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
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- 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 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
- 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
Who cannot join
- 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
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- 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 5.4.1 and 5.4.2)
- 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 inclusive of thyroid stimulating hormone 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B 3L1
Erin Lewis, PhD
About this study
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
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).
- Conditions
- Fatigue, Cancer, Treatment-Related
- Being tested
- Redsenol-1 Plus, Placebo
- Keywords
- Safety and efficacy, Cancer-related fatigue, Ginseng
- Medical subject headings
- Fatigue, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redsenol-1 PlusDietary supplement
Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
PlaceboOther
Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).
| Study group | Role | What they receive |
|---|---|---|
| Redsenol-1 Plus | Experimental | Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible. Receives: Dietary Supplement: Redsenol-1 Plus |
| Placebo | Placebo comparator | Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the severity of cancer-related fatigue from baseline to week 12.
The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Measured: baseline and 84 days
Secondary outcomes (32)
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8 as assessed by the FACIT-F fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Measured: baseline, 28 days, 56 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F total score.
Measured: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F physical well-being (PWB) sub-scale.
Measured: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the social well-being (SWB) sub-scale.
Measured: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the emotional well-being (EWB) sub-scale.
Measured: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the functional well-being (FWB) sub-scale.
Measured: baseline, 28 days, 56 days, 84 days
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue from baseline to 4 weeks, 8 weeks, and 12 weeks.
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue as assessed by the FACIT-F fatigue subscales from baseline to 4 weeks, 8 weeks, and 12 weeks between Redsenol-1 Plus compared to placebo.
Measured: baseline, 28 days, 56 days, 84 days
The difference in performance status from baseline to weeks 4, 8, and 12.
The difference in performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) tool from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
Measured: baseline, 28 days, 56 days, 84 days
The difference in mood from baseline to weeks 4, 8, and 12.
The difference in mood as assessed by the Profile of Mood States (POMS) questionnaire from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
Measured: baseline, 28 days, 56 days, 84 days
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks will be collected at screening and baseline and will be compared to post-emergent AEs to enable identification of AEs that may be potentially related to the investigational product.
Measured: 84 days
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks. Blood pressure will be determined from 3 measurements obtained at least 1 minute apart. One arm will be chosen and used consistently throughout the study. Blood pressure will be checked in both arms at the first examination.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo will be will be determined from 3 measurements obtained at least 1 minute apart. One arm will be chosen and used consistently throughout the study. Blood pressure will be checked in both arms at the first examination.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Aspartate aminotransferase (AST) will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Alanine aminotransferase (ALT) will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Alkaline phosphatase (ALP) will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Total bilirubin will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Creatinine will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Electrolytes will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Glucose will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Estimated glomerular filtration rate (eGFR) will be measured in blood from study participants at 12 weeks.
Measured: 84 days
White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
White blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Red blood cell count will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Hemoglobin will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Hematocrit will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Platelet count will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular volume will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular hemoglobin will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular hemoglobin concentration will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Red blood cell distribution will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Immature granulocytes will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Nucleated red blood cells will be measured in blood from study participants at 12 weeks.
Measured: 84 days
Incidence of adverse events during the follow-up period (weeks 12-16).
Incidence of adverse events during the 4-week follow-up period (weeks 12-16).
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start30 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canada Royal Enoch Phytomedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664009
- Sponsor's protocol ID
- 22EPRSZ03
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
- ClinicalTrials.gov ID
- NCT05664009
- Acronym / sponsor ID
- 22EPRSZ03
- Conditions
- Fatigue, Cancer, Treatment-Related
- Keywords
- Safety and efficacy, Cancer-related fatigue, Ginseng
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Canada Royal Enoch Phytomedicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Redsenol-1 Plus | Experimental | Dietary Supplement: Redsenol-1 PlusParticipants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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,
- 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:
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redsenol-1 PlusTwo capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days). | Dietary supplement | Redsenol-1 Plus |
| PlaceboTwo capsules of Placebo will be taken three times per day for 12 weeks (84 days). | Other | Placebo |
Primary outcome
The change in the severity of cancer-related fatigue from baseline to week 12.
Time frame: baseline and 84 days
The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.
32 secondary outcomes
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
Time frame: baseline, 28 days, 56 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue from baseline to 4 weeks, 8 weeks, and 12 weeks.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in performance status from baseline to weeks 4, 8, and 12.
Time frame: baseline, 28 days, 56 days, 84 days
The difference in mood from baseline to weeks 4, 8, and 12.
Time frame: baseline, 28 days, 56 days, 84 days
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time frame: 84 days
Incidence of adverse events during the follow-up period (weeks 12-16).
Time frame: 112 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redsenol-1 Plus in people with Fatigue and Cancer, Treatment-Related, run by Canada Royal Enoch Phytomedicine Co., Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the severity of cancer-related fatigue from baseline to week 12. (time frame: baseline and 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.