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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
180
1000mg Sachet, (1 sachet X 3 times a day)
1000mg sachet, (1 sachet X 3 times a day)
Department of Medical Oncology (In Charge - Oncology Unit)
Srikakulam, Andhra Pradesh, India
RECRUITINGHanji Cancer Centre
Belagavi, Karnataka, India
RECRUITINGK.R. Hospital, Mysore Medical College & Research Institute
Mysuru, Karnataka, India
RECRUITINGOnco- Life Cancer
Satara, Maharashtra, India
RECRUITINGOnco-Life Cancer Centre, Pvt. Ltd
Talegaon Dābhāde, Maharashtra, India
RECRUITINGAvicenna Hospital
Lucknow, Uttar Pradesh, India
RECRUITINGChanges 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 weeks
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 weeks
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 weeks
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