What side effects are associated with this type of intervention?

Common treatments for fatigue that modulate immune response and reduce inflammation, such as omega-3 fatty acid supplements, are generally well-tolerated but can cause side effects like gastrointestinal disturbances, including diarrhea. Other anti-inflammatory agents may also lead to mild side effects such as nausea, headaches, or allergic reactions. It is important to monitor for these side effects and consult with a healthcare provider to manage any adverse reactions effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for fatigue, particularly in the context of specific conditions like multiple sclerosis (e.g., amantadine, modafinil) and cancer-related fatigue (e.g., corticosteroids, methylphenidate). These treatments often work by modulating neurotransmitter levels or reducing inflammation. While there are no direct references to treatments exactly like Redsenol-1 Plus, which aims to modulate the immune response and reduce inflammation, the general approach of using anti-inflammatory agents and immune modulators is consistent with current therapeutic strategies for managing fatigue in various chronic conditions.

What other types of research exist?

Promising novel alternatives to Redsenol-1 Plus for treating fatigue in 2024 include: 1) Secukinumab, a monoclonal anti-interleukin-17A antibody, which has shown efficacy in reducing inflammation in rheumatoid arthritis patients. 2) Omega-3 fatty acid supplements, which have demonstrated modest improvements in symptoms of systemic immune diseases. 3) Thymosin beta-4, a peptide with wound-healing and anti-inflammatory properties, which has shown improvement in severe dry eye disease, potentially indicating broader anti-inflammatory benefits.

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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

Summary

This trial is testing Redsenol-1 Plus to see if it can help reduce tiredness in adults with cancer. They will also check if the treatment is safe and if there are any side effects.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for fatigue, such as Redsenol-1 Plus, often work by modulating the immune response and reducing inflammation. These treatments aim to address the systemic inflammation and immune dysregulation that are frequently associated with chronic fatigue conditions. By targeting these underlying mechanisms, these treatments can help alleviate fatigue symptoms, thereby improving the overall quality of life for patients suffering from chronic fatigue.

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