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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redsenol-1 Plus | Dietary Supplement | Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 28 days, 56 days |
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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,
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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B 3L1 | Canada |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009369 | Neoplasms |
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| Placebo | Other | Two capsules of Placebo will be taken three times per day for 12 weeks (84 days). |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 112 days |