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The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
The main questions it aims to answer are:
Does Nuvastatic™ reduce cancer-related fatigue as measured by change in the Brief Fatigue Inventory (BFI) from baseline to end of treatment? Does Nuvastatic™ improve quality of life, safety outcomes, and clinical parameters compared with placebo during chemotherapy?
Researchers will compare patients receiving Nuvastatic™ plus standard chemotherapy with patients receiving placebo plus standard chemotherapy to see if Nuvastatic™ leads to greater reductions in fatigue, improved quality of life, and acceptable safety while undergoing treatment.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1000mg sachet effervescent powder Placebo (1 sachet X 3 times a day) |
|
| Nuvastatic ™ | Experimental | 1000mg sachet effervescent powder Nuvastatic ™ (1 sachet X 3 times a day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuvastatic ™ | Drug | Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Fatigue Inventory (BFI) score | The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS). | At baseline until end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Secondary Outcome Measures are: Fatigue assessment using SF-36 Questionnaire from screening to EOT. Change in Global Health Status/QoL score as measured by EORTC QLQ-C30 from screening to EOT. Incidence of adverse events (AEs) graded according to CTCAE v5.0. Tumor response assessed by RECIST 1.1 criteria from baseline to EOT. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarker | To investigate whether urinary F2-isoprostane (F2-IsoP) excretion correlates with the severity of cancer-related fatigue (CRF) in patients undergoing chemotherapy | at baseline and end of treatment at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
This study is only for women who have been diagnosed with breast cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital, | Srikakulam | Andhra Pradesh | 532001 | India |
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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Design
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| Placebo | Drug | greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet |
|
| At baseline and end of treatment at 12 weeks |
| Changes in biomarkers | Change in serum CEA (ng/mL) and CA15-3 (U/mL) levels from screening to EOT. Change in laboratory parameters from screening to EOT. | At baseline and end of treatment at 12 weeks |
| 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 |
| Avicenna Hospital | Lucknow | Uttar Pradesh | 226016 | India |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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