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

Taichung Veterans General Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma.

Treatments: Dietary Supplement: Vitamin B-6+Coenzyme Q10; Other: Placebo; Dietary Supplement: Vitamin B-6; Dietary Supplement: Coenzyme Q10

Study type: Interventional

Funder types: Other

Identifiers

NCT01964001

CF13197

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

starch

Treatment:

Other: Placebo

Dietary supplements

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin B-6+Coenzyme Q10

Dietary Supplement: Coenzyme Q10

Dietary Supplement: Vitamin B-6