A trial to identify if Aspirin can reduce hearing loss for patients receiving Cisplatin chemotherapy

Phase 1

Active, not recruiting

• Conditions: To establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin based chemotherapy.; MedDRA version: 18.0Level: PTClassification code 10033109Term: OtotoxicitySystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001509-25-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-10
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1.Written Informed Consent
2.Any patient deemed fit for chemotherapy with acceptable laboratory values and offered a cumulative dose equal to or more than 200mg/m2 Cisplatin as a single agent or as a combination chemotherapy for malignancy with planned treatment of a maximum of two consecutive days Cisplatin per cycle.
3.Over 18 years old.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Previous Cisplatin treatment.
2.Patients with a diagnosis of Nasopharyngeal (or skull base) Carcinoma.Patients with other head and neck tumours being treated with radiotherapy are eligible.
3.Patients where planned Cisplatin is to be given as a split dose regimen on Days 1 to 5 or on Days 1 and 8.
4.Patients receiving therapeutic Aspirin defined as >75mg per day.
5.Previous Haemorrhagic stroke.
6.Inflammatory bowel disease.
7.Patients with absolute contraindications to Aspirin, PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
8.Haematological or clotting disorders.
9.Patients with symptomatically overt hearing loss which the principal investigator considers should exclude the use of cisplatin.
10.Pregnant or breast-feeding patients. Women of childbearing potential must have a standard negative pregnancy test performed within 7days prior to the start of Trial drug. Both men and women enrolled in this Trial must use adequate birth control.
11.Patients enrolled or who plan to enrol in any other IMP or Surgical Interventional Clinical Trial during the Trial period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified