Can a herbal sachet beat chemo fatigue? new trial aims to find out
NCT ID NCT07669519
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This Phase 3 study tests whether Nuvastatic, a herbal supplement taken as a powder sachet three times daily, can reduce cancer-related fatigue in adults with stage IV colon cancer who are starting chemotherapy. About 180 participants will receive either Nuvastatic or a placebo for 60 days while continuing their standard chemo. The main goal is to see if fatigue scores improve, with safety also closely monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nuvastatic (herbal supplement sachet)
- What this could lead to
- If it works, this could offer a new option to reduce severe fatigue in colon cancer patients undergoing chemotherapy, improving their daily quality of life.
- What could go wrong
- This is a Phase 3 trial, but fatigue is subjective and hard to measure. The supplement may not outperform placebo, and its safety in this setting is still being confirmed.
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 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2027
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: 1. Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study. 2. Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively. 3. Patients must have a confirmed diagnosis of colon cancer as per standard guideline. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening. 5. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening. 6. Life expectancy ≥ 6 months, as per Investigator's judgment 7. 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 8. At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included. 9. Starting first-line chemo Exclusion Criteria: 1. 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. 2. Patients who have stage IV Disease 3. 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. 4. Prior metastatic chemo, targeted/immunotherapy, severe comorbidities 5. Female patients who are pregnant or breast-feeding. 6. Patients with known hepatitis C virus, hepatitis B virus, HIV infection. 7. 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. 8. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. ' 9. Patients with planned therapy or treatment with another investigational agent. 10. 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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Avicenna Hospital
RECRUITINGLucknow, Uttar Pradesh, 226016, India
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Department of Medical Oncology (In Charge - Oncology Unit)
RECRUITINGSrikakulam, Andhra Pradesh, 532001, India
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Hanji Cancer Centre
RECRUITINGBelagavi, Karnataka, 590006, India
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K.R. Hospital, Mysore Medical College & Research Institute
RECRUITINGMysuru, Karnataka, 570001, India
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Onco- Life Cancer
RECRUITINGSatara, Maharashtra, 415519, India
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Onco-Life Cancer Centre, Pvt. Ltd
RECRUITINGTalegaon Dābhāde, Maharashtra, 410506, India
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Other studies related to the condition(s) this trial covers.
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- Can surgeons spare nerves and still cure colon cancer?
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- Blood test could guide stronger chemo for colon cancer
- Can a virtual stress program help working spouses care for cancer patients without burning out?
- Can a Two-Drug immunotherapy combo shrink MSS colon cancer before surgery?