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

NCT ID: NCT04713332

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-06
• Study Completion Date: 2021-05-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

vitamin E

Oral intake of Vitamin E treatment will be given on a daily basis in a single-blind manner one day before the first day of RT and continued for 8 weeks. Patients in the group receiving 500 IU of d-alpha-tocopherol capsules orally (3 times daily).

Group Type: ACTIVE_COMPARATOR

Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

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.

Hydrogen rich water

Oral intake of HRW (2 ppm) treatment will be given on a daily basis in a single-blind manner one day before the first day of RT and continued for 8 weeks. The group of patients receiving Hydrogen water took an amount of 250 ml orally 3 times a day.

Group Type: ACTIVE_COMPARATOR

Hydrogen rich water

Intervention Type: DIETARY_SUPPLEMENT

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.

placebo

Oral intake of placebo will be given on a daily basis in a single-blind manner one day before the first day of RT and continued for 8 weeks. The placebo group received 3 soft gel placebo capsules containing gelatin three times a day.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

500 IU of d-alpha-tocopherol

Eligibility Criteria

Inclusion Criteria

• - Men or women.
• Older than 18 years.
• Histologically proven adenocarcinoma of the rectum.
• Underwent radiotherapy.
• Absence of any psychological, and sociological condition that potentially affects the compliance with the study protocol and follow-up schedule.

Exclusion Criteria

• The use of anticoagulant and antiplatelet agents.
• Any disease of disorder capable of contraindicating the absorption of Vitamin E or Hydrogen water in the body of a patient being investigated.
• No known history of problems absorbing fats (e.g., Crohn disease, cystic fibrosis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Al-Quds University

OTHER

Sponsor Role: collaborator

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Ziad Abuawad

PhD Candidates in Human Nutrition and Dietetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Musa Numan, Professor

Role: STUDY_CHAIR

The University of Jordan

Jan Slezak, Professor

Role: STUDY_CHAIR

The Slovak Academy of Sciences

Locations

Augusta Victoria Hospital

East Jerusalem, , Palestinian Territories

Site Status: RECRUITING

Countries

Palestinian Territories

Central Contacts

Ziad Abuawad, PhD candidate

Role: CONTACT

ziad_252002@yahoo.com

00970598966442

Facility Contacts

Atif Rimawi, PhD

Role: primary

ati_rimawi@yahoo.comf

00972547951918

Other Identifiers

RCT-2021

Identifier Type: -

Identifier Source: org_study_id