Gabapentin for taxane associated acute pain syndrome - randomised, placebo-controlled, crossover trial. The TAPS Trial

Phase 3

• Conditions: Breast cancer; Taxane associated acute pain syndrome; Cancer - Breast

• Registration Number: ACTRN12611000666921
• Lead Sponsor: Sunshine Coast Cancer Centre, Nambour General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Patients with histologically confirmed adenocarcinoma of the breast who have completed definitive surgery and meet the following criteria
1.Planned and agreeable to treatment with docetaxel 100mg/m2 3 weekly as part of the regimen FEC-
D for early stage breast cancer
2.Adequate organ function for the planned chemotherapy
3.Creatinine clearance of >50ml/min by estimated glomerular filtraiton rate
4.Ages 18 years or over
5.Able to give informed consent
6.Received no prior taxane chemotherapy

Exclusion Criteria

1.Score of 4 or more for ‘pain on average over the last 24 hours” on day prior to cycle 1 docetaxel (i.e.
pre existing pain)
2.Regular use of analgesia (other than for post operative pain)
3.Epilepsy or seizure disorder
4.Metastatic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effects of gabapentin on patient reported worst pain score (pain that is new since your last dose of chemotherapy) using a numeric rating scale[Daily for a week after chemotherapy]