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

University of Jordan

Status and phase: Unknown; Phase 3

Conditions: Radiation-induced Injuries in Patients With Rectal Cancer

Treatments: Dietary Supplement: Vitamin E; Dietary Supplement: Hydrogen rich water; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04713332

RCT-2021

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

vitamin E

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Vitamin E

Hydrogen rich water

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Hydrogen rich water

placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: placebo