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Recruiting NCT07598214

Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients

Phase IV Interventional Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: diosmin/hesperdin.
Who it may be relevant to
Registry conditions: Cancer Patients. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effect of Diosmin/Hesperidin Combination on Platinum Compounds-Induced Nephropathy in Cancer Patients: A Randomized Controlled Trial

Overview

The current study aims to investigate the protective properties of diosmin/hesperidin on cisplatin-induced nephrotoxicity.

Detailed description

The current study is a prospective randomized controlled clinical study that will be conducted on about 100 cancer patients.

Study duration The study will be conducted from January 2025 to September 2025

Study population Group I (control): includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy.

Group II (Test group) includes 37 cancer patients administrating platinum compounds in their chemotherapeutic cycles as standard therapy plus 450 mg diosmin and 50 mg hesperidin combination orally twice daily.

Interventions

  • Combination product diosmin/hesperdin
    combination of Diosmin and Hesperidin

Primary outcome measures

  • serum creatinine level [Time frame: 6 months following treatment]
  • blood urea level [Time frame: 6 months following treatment]
Secondary outcome measures (1)
  • hemoglobin level [Time frame: 6 months following treatment]

Eligibility criteria

Inclusion criteria

  • Patients of 18 to 75 year-age must have histologically or cytologically confirmed cancer by the Laboratory of Pathology receiving a platinum compound chemotherapy.

Exclusion criteria

  • -History of allergic reactions attributed to drugs in the study.
  • Pregnant women.
  • Life expectancy less than 6 months
  • Inability or unwillingness to comply with research protocols.
  • Cancer patients with impaired renal function (creatinine clearance < 50 mL/min)
  • Preexisting hearing loss.
  • Patients taking nephrotoxic drugs; and those who have a history of allergic reactions to platinum-containing compounds.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine — Banī Suwayf

Identifiers

NCT: NCT07598214 · FMBSUREC/03122024/Mahmoud · FWA00015574

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗