Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy

Sponsor
Natureceuticals Sdn Bhd
Study ID
NCT07669519
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Nuvastatic™ — DRUG
    1000mg Sachet, (1 sachet X 3 times a day)
  • Placebo — DRUG
    1000mg sachet, (1 sachet X 3 times a day)

Study Details

The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy. The main questions it aims to answer are: Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population? Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.

Key Dates

First listed
Jun 25, 2026
Start date
Aug 18, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nuvastatic™
    Nuvastatic™ 1000mg Sachet
  • Placebo Comparator: Placebo
    Placebo 1000mg Sachet

Primary Outcome Measure

Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. [ Time Frame: from screening up to 12 weeks ]

Central Contacts

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