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Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going to administration for three months. The concentrations of vitamin B-6, coenzyme Q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A and E), and inflammatory markers are going to be analyzed. The results would provide more information nutrients for clinical physicians and dietitians for considering suggesting patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | starch |
|
| Dietary supplements | Experimental | Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B-6 | Dietary Supplement | Vitamin B-6 50 mg/d |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant capacity | This study are going to measure the indicators of antioxidant capacity including Vitamin B-6, coenzyme Q10, vitamin A and E, lipid peroxidation markers (malondialdehyde), and antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation markers | This study are going to measure the inflammation markers including C-reactive protein, Tumor necrosis factor-alfa, Interleukin-1 beta, Interleukin-6,adiponectin, homocysteine, S-adenosyl-methionine, and S-adenosyl-homocysteine. | 12 weeks |
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Inclusion Criteria:
- The HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Verterans General Hospital | Taichung | 40705 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716246 | Derived | Liu HT, Huang YC, Cheng SB, Huang YT, Lin PT. Effects of coenzyme Q10 supplementation on antioxidant capacity and inflammation in hepatocellular carcinoma patients after surgery: a randomized, placebo-controlled trial. Nutr J. 2016 Oct 6;15(1):85. doi: 10.1186/s12937-016-0205-6. | |
| 27051670 | Derived | Cheng SB, Lin PT, Liu HT, Peng YS, Huang SC, Huang YC. Vitamin B-6 Supplementation Could Mediate Antioxidant Capacity by Reducing Plasma Homocysteine Concentration in Patients with Hepatocellular Carcinoma after Tumor Resection. Biomed Res Int. 2016;2016:7658981. doi: 10.1155/2016/7658981. Epub 2016 Mar 9. |
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| Coenzyme Q10 |
| Dietary Supplement |
Coenzyme Q10 300 mg |
|
| Vitamin B-6+Coenzyme Q10 | Dietary Supplement | Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d) |
|
| Placebo | Other | starch |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D025101 | Vitamin B 6 |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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