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

Sponsor
Canada Royal Enoch Phytomedicine Co., Ltd.
Study ID
NCT05664009
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cancer, Treatment-Related
  • Fatigue

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Redsenol-1 Plus — DIETARY_SUPPLEMENT
    Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
  • Placebo — OTHER
    Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Study Details

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).

Key Dates

First listed
Dec 23, 2022
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Redsenol-1 Plus
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

The change in the severity of cancer-related fatigue from baseline to week 12. [ Time Frame: baseline and 84 days ]

Central Contacts

Related Studies