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

NCT07669519 | Recruiting Phase 3

• 2 other identifiers: NUVA-CC-III-2025NatureCeuticals Sdn Bhd
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Fatigue; Colon Cancer

Keywords

Colon Cancer; Cancer-Related Fatigue; Nuvastatic; Randomized Double-Blind Placebo-Controlled Trial; First-Line Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  From Screening up to 12 weeks

Secondary Outcomes (1)

• Overall QoL and functional improvement

  at baseline and at end of the study at 12 weeks

Study Arms (2)

Nuvastatic™

EXPERIMENTAL

Nuvastatic™ 1000mg Sachet

Drug: Nuvastatic™

Placebo

PLACEBO COMPARATOR

Placebo 1000mg Sachet

Drug: Placebo

Interventions

Nuvastatic™ DRUG

1000mg Sachet, (1 sachet X 3 times a day)

Nuvastatic™

Placebo DRUG

1000mg sachet, (1 sachet X 3 times a day)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
• Life expectancy ≥ 6 months, as per Investigator's judgment
• Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deemed stable by the investigator can be included in the study
• At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
• Starting first-line chemo

You may not qualify if:

• 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
• Female patients who are pregnant or breast-feeding.
• Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
• Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the Investigator.
• Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '
• Patients with planned therapy or treatment with another investigational agent.
• Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.

Sponsors & Collaborators

• Natureceuticals Sdn Bhd: lead

Study Sites (6)

Department of Medical Oncology (In Charge - Oncology Unit)

Srikakulam, Andhra Pradesh, 532001, India

RECRUITING

Hanji Cancer Centre

Belagavi, Karnataka, 590006, India

RECRUITING

K.R. Hospital, Mysore Medical College & Research Institute

Mysuru, Karnataka, 570001, India

RECRUITING

Onco- Life Cancer

Satara, Maharashtra, 415519, India

RECRUITING

Onco-Life Cancer Centre, Pvt. Ltd

Talegaon Dābhāde, Maharashtra, 410506, India

RECRUITING

Avicenna Hospital

Lucknow, Uttar Pradesh, 226016, India

RECRUITING

MeSH Terms

Conditions

Fatigue; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Aman Shah Abdul Majid, MBChB, DPhil

CONTACT

+605-2490500; amanharvard2020@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Details of the investigational product (Nuvastatic or placebo) are concealed from both the study investigators and the trial participants. Each enrolled subject receives a randomization code allocated sequentially through IWRS.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled, Parallel-group study

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: June 25, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

IN (6)