To establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin based chemotherapy. MedDRA version: 18.0 Level: PT Classification code 10033109 Term: Ototoxicity System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Aspirin
CAS Number: CAS 50-78-2
Other descriptive name: Acetylsalicylic acid
Concentration unit: mg mi
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A trial to identify if Aspirin can reduce hearing loss for patients receiving Cisplatin chemotherapy.;Secondary Objective: 1. To identify if it is feasible to conduct a Phase III randomised control trial of Aspirin for the same patient population. 2. To measure the degree of hearing loss in patients receiving Cisplatin using a hearing test called the Otoacoustic emissions (OAE) test. 3. To find out if patients can tolerate short-term, large doses of Aspirin taken with Omeprazole without unpleasant side-effects and without having to reduce the dosage of their Cisplatin chemotherapy. 4. Additional consent will be asked to collect blood and urine samples for future ethically approved trials. These samples will be stored at the Cancer Sciences Tissue Bank, Southampton General Hospital. Patients do not have to agree to give these samples if they do not wish to. They will still be able to take part in the main trial.;Primary end point(s): The primary endpoint is the total difference in hearing before and within 4 to 7 days after finishing treatment, using the pure tone audiogram (PTA) test at frequencies of 6 and 8 kHz in both ears.;Timepoint(s) of evaluation of this end point: All patients will receive a pre-treatment hearing test which will be used as a baseline measurement. Patients will have a second hearing test 4 to 7 days post treatment. They will then have a final hearing test three months after completion of their Cisplatin chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Total difference in hearing before and 3 months after treatment using the PTA test at frequencies of 6 and 8 kHz in both ears. 2.Common Toxicity Criteria (CTC) – a clinician assessed level of hearing loss. 3.OAE profile, before and 4 to 7 days after treatment, and a further 3 months after finishing treatment). 4.Safety profile assessment (including gastro-intestinal and renal toxicity). 5.Assessment of compliance and concomitant medications as well as total dose of Cisplatin received. 6.Assessment of other PTA test-frequencies including 0.25, 0.5, 1, 2, 3, 4 kHz at baseline and 4 to 7 days after finishing treatment. The final test to be done a further 3 months after treatment. 7.Cisplatin dose-intensity. ;Timepoint(s) of evaluation of this end point: • All hearing assessments (PTA and OAE) will be at baseline, 4 to 7 days after finishing Cisplatin treatment and 3 months after finishing Cisplatin treatment. • Common Toxicity Criteria (CTC) – a clinician assessed level of hearing loss at each patient visit. • Safety profile assessment (including gastro-intestinal and renal toxicity) at each patient visit. • Assessment of compliance and concomitant medications as well as total dose of Cisplatin received at each patient visit. • Cisplatin dose-intensity assessed at each patient visit. | — |
Countries
United Kingdom
Contacts
Public ContactKaren Martin, Trials Manager
Southampton Clinical Trials Unit
Outcome results
None listed