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Dietary Supplement

Redsenol-1 Plus for Cancer-related Fatigue

Phase 2

Recruiting

Led By David Crowley, MD

Research Sponsored by Canada Royal Enoch Phytomedicine Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 28 days, 56 days, 84 days

Awards & highlights

Study Summary

This trial evaluates the safety & efficacy of Redsenol-1 Plus on cancer-related fatigue in adults who have received cancer treatment. Effects & safety will be measured.

Who is the study for?

Adults aged 18-65 who have completed cancer treatment and are experiencing fatigue, with a CRF score of ≥4. Women must not be pregnant or planning pregnancy, using reliable birth control if applicable. Participants should have stable health without certain conditions like CNS malignancies, untreated high blood pressure, recent major surgery, or substance abuse.Check my eligibility

What is being tested?

The trial is testing Redsenol-1 Plus against a placebo to see if it helps reduce cancer-related fatigue in adults post-cancer treatment. The main measure is the change in fatigue severity at week 12 using the FACIT-F scale.See study design

What are the potential side effects?

While specific side effects aren't listed for Redsenol-1 Plus, participants will be monitored for any new adverse events compared to those taking a placebo to assess safety and tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 28 days, 56 days, 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 28 days, 56 days, 84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 28 days, 56 days, 84 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change in the severity of cancer-related fatigue from baseline to week 12.

Secondary outcome measures

Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.

Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.

Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.

+25 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Redsenol-1 PlusExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Canada Royal Enoch Phytomedicine Co., Ltd.Lead Sponsor

KGK Science Inc.Industry Sponsor

78 Previous Clinical Trials

6,088 Total Patients Enrolled

David Crowley, MDPrincipal InvestigatorKGK Science Inc.

35 Previous Clinical Trials

2,681 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Redsenol-1 Plus be detrimental to a patient's health?

"Our research team at Power assigned Redsenol-1 Plus a safety rating of 2, as this is only Phase 2 trial and there has yet to be evidence presented that supports the drug's efficacy."

Answered by AI

Are individuals of a younger age bracket eligible for this experiment?

"Participants between the ages of 18 and 65 meet the eligibility criteria for this trial; there are 9 trials specifically targeting those below age 18 and 234 focusing on those over 65."

Answered by AI

Could potential candidates still join this research endeavor?

"Clinicaltrials.gov reveals that this research trial is still searching for participants, with the initial post having been placed on 30th May 2023 and most recently updated a few months later during September 5th of the same year."

Answered by AI

How many participants are engaging in the current research project?

"Affirmative, according to clinicaltrials.gov this trial is still open for enrolment. The initial posting date was May 30th 2023 and the most recent update occured September 5th 2023. 72 patients are needed to be recruited at a single research setting."

Answered by AI

What criteria must one fulfill to qualify for participation in this clinical trial?

"This trial is recruiting 72 persons aged 18 to 65 with persistent fatigue. The study also requires that eligible individuals be of non-childbearing potential, use contraception if sexually active, and have a CRF score of 4 or higher. Furthermore, subjects who recently underwent cancer treatment are ineligible for the study unless otherwise approved by the Qualified Investigator."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

2023. "The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664009.