Clinical trial NCT01964001: The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma.
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Antioxidant capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Inflammation markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital
Study officials:
References:
citation: 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.
citation: 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.