FatiguePhase 3NuvastaticTMNCT07669519
Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
A Phase 3 study testing Nuvastatic™ in people with Fatigue and Colon Cancer, run by Natureceuticals Sdn Bhd at 6 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue, Colon Cancer
- What is being tested?
- Nuvastatic™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 6 sitesIndia
- Study dates
- 18 Aug 2025to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 6 recruiting
- Recruiting
Hanji Cancer Centre
Belagavi, Karnataka, 590006
- Recruiting
Avicenna Hospital
Lucknow, Uttar Pradesh, 226016
- Recruiting
K.R. Hospital, Mysore Medical College & Research Institute
Mysuru, Karnataka, 570001
- Recruiting
Onco- Life Cancer
Satara, Maharashtra, 415519
- Recruiting
Department of Medical Oncology (In Charge - Oncology Unit)
Srikakulam, Andhra Pradesh, 532001
- Recruiting
Onco-Life Cancer Centre, Pvt. Ltd
Talegaon Dābhāde, Maharashtra, 410506
About this study
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
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:
Read more
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
- Being tested
- Nuvastatic™, Placebo
- Keywords
- Colon Cancer, Cancer-Related Fatigue, Nuvastatic, Randomized Double-Blind Placebo-Controlled Trial, First-Line Chemotherapy
- Medical subject headings
- Fatigue, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvastatic™Drug
1000mg Sachet, (1 sachet X 3 times a day)
PlaceboDrug
1000mg sachet, (1 sachet X 3 times a day)
| Study group | Role | What they receive |
|---|---|---|
| Nuvastatic™ | Experimental | Nuvastatic™ 1000mg Sachet Receives: Drug: Nuvastatic™ |
| Placebo | Placebo comparator | Placebo 1000mg Sachet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From Screening up to 12 weeks
Secondary 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.
Measured: at baseline and at end of the study at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start18 Aug 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled, Parallel-group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natureceuticals Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669519
- Sponsor's protocol ID
- NUVA-CC-III-2025
- Other IDs
- NatureCeuticals Sdn Bhd
- Acronym
- NuvastaticTM
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT07669519
- Acronym / sponsor ID
- NuvastaticTM / NUVA-CC-III-2025
- Conditions
- Fatigue, Colon Cancer
- Keywords
- Colon Cancer, Cancer-Related Fatigue, Nuvastatic, Randomized Double-Blind Placebo-Controlled Trial, First-Line Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Natureceuticals Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled, Parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Nuvastatic™ | Experimental | Drug: Nuvastatic™Nuvastatic™ 1000mg Sachet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1000mg Sachet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvastatic™1000mg Sachet, (1 sachet X 3 times a day) | Drug | Nuvastatic™ |
| Placebo1000mg sachet, (1 sachet X 3 times a day) | Drug | Placebo |
Primary outcome
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time frame: from screening up to 12 weeks
intra-individual changes in the Brief Fatigue Inventory (BFI)
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time frame: From Screening up to 12 weeks
Fatigue scale and Visual Analogue Fatigue Scale (VAFS)
1 secondary outcome
Overall QoL and functional improvement
Time frame: at baseline and at end of the study at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Related trials for Fatigue
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nuvastatic™ in people with Fatigue and Colon Cancer, run by Natureceuticals Sdn Bhd at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aman Shah Abdul Majid, MBChB, DPhil (+605-2490500, amanharvard2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. (time frame: from screening up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.