Nuvastatic 300
Drug300mg capsule, (3 capsules X 3 times a day)
NCT Number: NCT07669454
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total ~120 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 3
Omega Hospital Chinna Gadhili, Visakhapatnam, Andhra Pradesh, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300mg capsule, (3 capsules X 3 times a day)
300mg capsule, (3 capsules X 3 times a day)
Time frame: From Screening to EOT (about 6 months)
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale
Time frame: From Screening to EOT (about 6 months)
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS)
Time frame: at baseline and at end of the study (about 6 months)
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
Time frame: At baseline and at end of treatment (about 6 months)
ECOG scores will be compared at baseline and at end of the study.
Contact information is provided by the study sponsor or research team.
Natureceuticals Sdn Bhd
Industry
Acronym: NuvastaticTM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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