Can a herbal capsule beat cancer fatigue? new trial aims to find out
NCT ID NCT07669454
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether Nuvastatic 300mg, a herbal supplement, can reduce cancer-related fatigue in adults with metastatic colorectal cancer who are receiving standard chemotherapy. About 250 participants will take either Nuvastatic or a placebo three times daily for about 120 days. The study measures fatigue levels and quality of life to see if the supplement offers meaningful relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nuvastatic 300mg capsule (herbal supplement)
- What this could lead to
- If it works, this could provide a safe option to ease severe fatigue in people with advanced colon cancer undergoing chemotherapy.
- What could go wrong
- This is a mid-stage trial with 250 participants, so results may not apply to everyone. The supplement may not reduce fatigue more than a placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively. * Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines. * Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening. * Life expectancy ≥ 6 months, as per investigator's judgment. * The patient has stable hemoglobin (≥ 9 g/dL)throughout the screening. * Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study. Exclusion Criteria: * 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 with an inability to understand local language(s) for scales used for evaluations, i.e., EORTC QLQ-C30, BFI, SF-36 and VAS-F. * Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug. * Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days. * Patients with known central nervous system (CNS) are involved by metastatic cancer. * Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator may affect the patient's safety or study participation and conduct. * Female patients who are pregnant or breastfeeding. * 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 known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Erode Cancer Care Centre
RECRUITINGErode, Tamil Nadu, 638012, India
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International Oncology Cancer Tower 1
RECRUITINGKanpur, Uttar Pradesh, India
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Jeevanjyoti Cancer Hospital
RECRUITINGJalgaon, Maharashtra, 425001, India
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K R Hospital
RECRUITINGMysore, Karnataka, 570001, India
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Omega Hospital Chinna Gadhili
RECRUITINGVisakhapatnam, Andhra Pradesh, 530040, India
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Sangavi Multispeciality Hospital Pvt. Ltd,
RECRUITINGPune, Maharashtra, 411027, India
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- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- Can surgeons spare nerves and still cure colon cancer?