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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
250
300mg capsule, (3 capsules X 3 times a day)
300mg capsule, (3 capsules X 3 times a day)
Omega Hospital Chinna Gadhili
Visakhapatnam, Andhra Pradesh, India
RECRUITINGK R Hospital
Mysore, Karnataka, India
RECRUITINGJeevanjyoti Cancer Hospital
Jalgaon, Maharashtra, India
RECRUITINGSangavi Multispeciality Hospital Pvt. Ltd,
Pune, Maharashtra, India
RECRUITINGErode Cancer Care Centre
Erode, Tamil Nadu, India
RECRUITINGInternational Oncology Cancer Tower 1
Kanpur, Uttar Pradesh, India
RECRUITINGReduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
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)
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS)
Time frame: From Screening to EOT (about 6 months)
Overall QoL and functional improvement
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 the study (about 6 months)
Overall QoL and functional Improvement
ECOG scores will be compared at baseline and at end of the study.
Time frame: At baseline and at end of treatment (about 6 months)
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