The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer

NCT01964001 | Completed Phase 2

• 1 other identifier: CF13197
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Inflammation markers

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

starch

Other: Placebo

Dietary supplements

EXPERIMENTAL

Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10

Dietary Supplement: Vitamin B-6; Dietary Supplement: Coenzyme Q10; Dietary Supplement: Vitamin B-6+Coenzyme Q10

Interventions

Vitamin B-6 DIETARY_SUPPLEMENT

Vitamin B-6 50 mg/d

Dietary supplements

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10 300 mg

Dietary supplements

Vitamin B-6+Coenzyme Q10 DIETARY_SUPPLEMENT

Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d)

Dietary supplements

Placebo OTHER

starch

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- The HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy.

You may not qualify if:

• age \< 20 years old.
• The patients who had heart, renal, gestational, diabetes, or other metabolic diseases.
• Under the medications which may interfere the vitamin B-6 or coenzyme Q10 concentrations, such as phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids, penicillamine, ,Statin, or Warfarin.
• The women who are during pregnancy or Lactation.
• The women who are taking the oral contraceptives.
• The subjects who are taking the dietary supplements, such as vitamin B-6, coenzyme Q10, or other antioxidant vitamins.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Verterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 27716246 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.

  PMID: 27051670 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Vitamin B 6; coenzyme Q10

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

TW (1)