Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNatureceuticals Sdn Bhd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.
Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.
Patients must have a confirmed diagnosis of colon cancer as per standard guideline.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
Disqualifiers
Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator's clinical judgment.
Patients who have stage IV Disease
Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug.
Prior metastatic chemo, targeted/immunotherapy, severe comorbidities
Trial design
Design model
Parallel
Treatments tested in this trial
Nuvastatic™
Drug1000mg Sachet, (1 sachet X 3 times a day)
Placebo
Drug1000mg sachet, (1 sachet X 3 times a day)
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Nuvastatic™Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
intra-individual changes in the Brief Fatigue Inventory (BFI)
Time frame
from screening up to 12 weeks2
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Fatigue scale and Visual Analogue Fatigue Scale (VAFS)
Time frame
From Screening up to 12 weeksSecondary outcomes
1
Overall QoL and functional improvement
The secondary outcome measure was the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study.
Time frame
at baseline and at end of the study at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov