Clinical trial NCT04713332: Effectiveness of Vitamin E and Hydrogen-Rich Water on Radiation Therapy-Induced Adverse In Patients With Rectal Cancer
Official title: Effectiveness of Vitamin E and Molecular Hydrogen-Rich Water on Radiation Therapy-Induced Adverse In Adult Patients With Rectal Carcinoma in Al-Quds, Palestine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiation-induced Injuries in Patients With Rectal Cancer
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Slovak Academy of Sciences
name: Al-Quds University
First posted: 2021-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: total blood count
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Nuclear factor erythroid 2-related factor 2 (Nrf2)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Superoxide dismutases (SOD)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Catalase (CAT)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Glutathione S-transferase (GST)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Malondialdehyde (MDA)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Tumor necrosis factors (TNF)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
measure: Matrix metalloproteinases(MMPs)
timeFrame: One day before the first day of radiation exposure (initial data) and 2, 6 and 8 weeks post radiation exposure
Secondary outcomes:
Other outcomes:
Locations:
city: E. Jerusalem
country: Palestinian Territory, occupied
facility: Augusta Victoria Hospital
Study officials:
affiliation: The University of Jordan
name: Musa Numan, Professor
role: STUDY_CHAIR
affiliation: The Slovak Academy of Sciences
name: Jan Slezak, Professor
role: STUDY_CHAIR
References: