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New plant-based treatment aims to fight chemo fatigue in breast cancer patients

NCT ID NCT07669506

Symptom relief Sponsor: Natureceuticals Sdn Bhd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether Nuvastatic, a plant extract, can reduce cancer-related fatigue in 180 women with breast cancer undergoing chemotherapy. Participants took Nuvastatic or a placebo three times daily for three chemo cycles. The study measured fatigue levels and quality of life using standard questionnaires. The goal is to find a safe, natural way to help patients feel less exhausted during treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nuvastatic (a plant extract)
What this could lead to
If it works, this could offer a natural option to ease severe fatigue during chemotherapy, helping patients feel better day-to-day.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Fatigue is subjective, and the placebo effect can be strong. The extract may not outperform placebo.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

180 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

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

18 to 65 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study. 2. Confirm diagnosis of Breast cancer as per the available Report. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening. 4. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening. 5. Life expectancy ≥ 6 months, as per Investigator's judgment 6. Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deem stable by the investigator can be included in the study 7. At screening patient with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included. Exclusion Criteria: 1. Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the Investigator's clinical judgement. 2. Patient who have stage IV Disease 3. Female patients who are pregnant or breast-feeding. 4. Patients with known hepatitis C virus, hepatitis B virus, HIV infection. 5. 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. 6. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. ' 7. Patients with planned therapy or treatment with another investigational agent. 8. 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.

breast cancer breast neoplasm Fatigue

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Chemotherapy, adjuvant Fatigue Quality of life

Contacts and locations

Locations

  • Avicenna Hospital

    Lucknow, Uttar Pradesh, 226016, India

  • Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital,

    Srikakulam, Andhra Pradesh, 532001, India

  • Hanji Cancer Centre

    Belagavi, Karnataka, 590006, India

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

    Mysuru, Karnataka, 570001, India

  • Onco-Life Cancer Centre

    Satara, Maharashtra, 415519, India

  • Onco-Life Cancer Centre, Pvt. Ltd (Talegaon General Hospital)

    Talegaon Dābhāde, Maharashtra, 410506, India

  • Siddharth Gupta Memorial Cancer Hospital (A Unit of Acharya Vinoba Bhave Rural Hospital)

    Wardha, Maharashtra, 442004, India

More trials for these conditions

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