Cisplatin Ototoxicity attenuated by ASpirin Trial (COAST)

Phase 2

Completed

• Conditions: Cancer

• Registration Number: ISRCTN83689269
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29128692

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-19
• Study Completion: 2015-12-29
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

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
4. Male or female

Exclusion Criteria

1. Previous cisplatin treatment
2. Patients with a diagnosis of Nasopharyngeal (or skull base) Carcinoma
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 transient ischaemic attacks or cerebral vascular disease
6. Severe ischaemic heart disease or myocardial infarction in the previous 6 months
7. Inflammatory bowel disease
8. Patients with absolute contraindications to Aspirin, PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants
9. Haematological or clotting disorders
10. Patients with pre-existing sensorineural hearing loss (>40dB at the standard audiometric frequencies (0.5 8 inclusive) in their worst hearing ear)
11. Pregnant or breastfeeding 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
12. 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total difference in hearing measured before and 7 days after treatment

Secondary Outcome Measures

Name	Time	Method
1. Assessment of compliance and concomitant medications measured during entire study duration<br>2. Assessment of other PTA test-frequencies measured at 7 days post treatment and 3 months post treatment<br>3. Cisplatin dose-intensity measured during entire study duration<br>4. Common Toxicity Criteria (CTC) measured during entire study duration<br>5. OAE profile measured 7 days after finishing treatment and a further 3 months after finishing treatment<br>5. Safety profile assessment measured during entire study duration<br>6. The total difference in hearing measured before and 3 months after treatment