Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNatureceuticals Sdn Bhd
About this trial
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules 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 300 mg capsules significantly reduce cancer-related fatigue compared to placebo? * Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
* Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). * Continue their standard first-line chemotherapy regimen. * Provide blood sample assessments at Screening and End of Treatment. * Complete patient diaries and fatigue assessments as per protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.
Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
Disqualifiers
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 judgment.
Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nuvastatic 300
Drug300mg capsule, (3 capsules X 3 times a day)
Placebo
Drug300mg capsule, (3 capsules X 3 times a day)
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Nuvastatic 300Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale.
Time frame
From Screening to EOT (about 6 months)Secondary outcomes
1
Overall QoL and functional improvement
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
Time frame
at baseline and at end of the study (about 6 months)2
Overall QoL and functional improvement
The secondary outcome measure is the overall QoL improvement using the ECOG scores that will be compared at baseline and at end of the study.
Time frame
At baseline and at end of the study (about 6 months)3
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS).
Time frame
From Screening to EOT (about 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov