Effectiveness of Vitamin E and Hydrogen-Rich Water on Radiation Therapy-Induced Adverse In Patients With Rectal Cancer

Summary

Controlled studies investigating the effects of vitamin E or H2 water or comparing their effectiveness on radiation therapy-induced injuries in RC patients are generally lacking. The present study hypothesis the following: (1) Pre - radiation therapy administration of vitamin E to patients with rectal carcinoma will provide radioprotection for exposed healthy tissues. (2) Consumption of H2 water by patients with rectal carcinoma undergoing RT will reduce the side effects of this modality. (3) Rectal cancer patients receiving H2 water will show better biological improvement than those receiving only vitamin E, i.e., H2 water is more effective antioxidant than vitamin E. (4) The proposed radiation countermeasures will not compromise the anti-tumor effects.

Conditions

• Radiation-induced Injuries in Patients With Rectal Cancer

Interventions

DIETARY_SUPPLEMENT

Vitamin E

Members of the vitamin E family are hydrophobic fat-soluble compounds found in a variety of food sources such as vegetable oils, fruits, and vegetables consumed through diet. Vitamin E exists in 8 isoforms, a, b, g, d-tocopherol, and a, b, g, d-tocotrienol. The recommended daily allowance for adults is 15 mg per day for alpha-tocopherol, an amount which is easily met by dietary sources, and 30 mg per day for synthetic all-rac-alpha-tocopherol. The upper limit for intake is 1,000 mg per day. Very often, the dosage of vitamin E is given in international units (IU) as capsules, with a typical dose being 400 IU per day, which is above the recommended daily allowance. The health benefits of consuming vitamin E through diet or supplementation are believed to be for its antioxidant properties as a peroxyl radical scavenger. Vitamin E protects cells from cell damage caused by free radicals that damage cell membranes through lipid oxidation leading to DNA damage and cancer development.

DIETARY_SUPPLEMENT

Hydrogen rich water

Molecular hydrogen is a new medical gas that can be dissolved in water and administered through drinking, inhalation, baths, intravenous drip. A growing body of evidence indicates that hydrogen, as a novel antioxidant, scavenges hydroxyl radical and peroxynitrite. In contrast to other antioxidants, gaseous molecular hydrogen efficiently penetrates cytoplasmic membranes and targets intracellular organelles, largely owing to its small size and neutral electricity. Thus, hydrogen has been suggested as a suitable candidate for the therapeutic strategies for various diseases, including certain types of cancer. Hydrogen has emerged as a promising cancer remedy as a preventative agent or in combined therapy with anticancer drugs. Hydrogen water consumption might mitigate the side effects of anticancer drugs by decreasing oxidative stress and ameliorating metamorphosis due to decreased apoptosis.

DIETARY_SUPPLEMENT

placebo

Placebo containing gelatin is made by cooking down the protein collagen found in the skin, hooves, connective tissues, and bones of animals. The cooking process breaks down the bonds between proteins to make smaller, more bioavailable building blocks that your body can easily absorb. Like collagen, gelatin is packed with beneficial amino acids, especially the anti-aging superstar's glycine and proline, which are lacking in the standard Western diet. These amino acids make gelatin especially powerful for healing skin, gut, and joint damage. Because collagen and gelatin come from the same source, they have identical amino acid profiles

Sponsors & Collaborators

• Slovak Academy of Sciences

  collaborator OTHER_GOV

• Al-Quds University

  collaborator OTHER

• University of Jordan

  lead OTHER

Principal Investigators

• Musa Numan, Professor · The University of Jordan

• Jan Slezak, Professor · The Slovak Academy of Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-06

Primary Completion

2021-03-08

Completion

2021-05-08

FDA Drug

Yes

Countries

• Palestinian Territories

Study Locations