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| ID | Type | Description | Link |
|---|---|---|---|
| NatureCeuticals Sdn Bhd | Other Grant/Funding Number | NatureCeuticals Sdn Bhd |
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The goal of this clinical trial is to evaluate whether Nuvastatic 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 significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population?
Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total ~60 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment.
Complete patient diaries and fatigue assessments as per protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nuvastatic™ | Experimental | Nuvastatic™ 1000mg Sachet |
|
| Placebo | Placebo Comparator | Placebo 1000mg Sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuvastatic™ | Drug | 1000mg Sachet, (1 sachet X 3 times a day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. | intra-individual changes in the Brief Fatigue Inventory (BFI) | from screening up to 12 weeks |
| Changes in cancer-related fatigue in colon cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. | Fatigue scale and Visual Analogue Fatigue Scale (VAFS) | From Screening up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall QoL and functional improvement | The secondary outcome measure was the 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. | at baseline and at end of the study at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aman Shah Abdul Majid, MBChB, DPhil | Contact | +605-2490500 | amanharvard2020@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology (In Charge - Oncology Unit) | Recruiting | Srikakulam | Andhra Pradesh | 532001 | India | |
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Randomized, Double-blind, Placebo-controlled, Parallel-group study
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Details of the investigational product (Nuvastatic or placebo) are concealed from both the study investigators and the trial participants. Each enrolled subject receives a randomization code allocated sequentially through IWRS.
| Placebo |
| Drug |
1000mg sachet, (1 sachet X 3 times a day) |
|
| Hanji Cancer Centre |
| Recruiting |
| Belagavi |
| Karnataka |
| 590006 |
| India |
| K.R. Hospital, Mysore Medical College & Research Institute | Recruiting | Mysuru | Karnataka | 570001 | India |
| Onco- Life Cancer | Recruiting | Satara | Maharashtra | 415519 | India |
| Onco-Life Cancer Centre, Pvt. Ltd | Recruiting | Talegaon Dābhāde | Maharashtra | 410506 | India |
| Avicenna Hospital | Recruiting | Lucknow | Uttar Pradesh | 226016 | India |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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