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NCT04713332

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

Status unknown Phase 3 Last updated 17 February 2021
What this trial tests

Phase 3 trial testing Vitamin E in Radiation-induced Injuries in Patients With Rectal Cancer in 60 participants. Status unknown.

Timeline
6 July 2019
Primary endpoint
8 March 2021
8 May 2021

Quick facts

Lead sponsorUniversity of Jordan
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date6 July 2019
Primary completion8 March 2021
Estimated completion8 May 2021
Sites1 location across Palestinian Territories

Drugs / interventions tested

Conditions studied

Sponsor

University of Jordan

Who can join

18 and older, any sex, with Radiation-induced Injuries in Patients With Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
    Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
  2. Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
    Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4

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Other trials of Vitamin E

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