TerminatedPhase 3ACTRN12611000666921

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

In patients receiving docetaxel for early stage breast cancer who experience taxane associated acute pain syndrome is gabapentin better than placebo for reducing pain?


Sponsor

Sunshine Coast Cancer Centre, Nambour General Hospital

Enrollment

126 participants

Start Date

Jan 2, 2012

Study Type

Interventional

Conditions

Summary

This study aims to assess the safety and efficacy of a drug called gabapentin for the treatment of acute pain syndrome associated with chemotherapy in women with breast cancer. Who is it for? You can join this study if you are a woman aged 18 years or more with early stage breast cancer for which you have had surgery. You must also plan to undergo chemotherapy treatment with the drug, docetaxel. Women who have pre-existing pain prior to chemotherapy will not be eligible. Trial details In this study, participants will be randomly (by chance) assigned to receive either the drug, gabapentin, or a placebo (sham) tablet during their second cycle of chemotherapy treatment. Gabapentin is a drug used to treat nerve pain. The dose of Gabapentin is 300mg three times a day, orally, starting the day before chemotherapy, for 6 days in total. On the third cycle of chemotherapy treatment, participants will be given the alternate treatment (i.e. gabapentin or placebo). Participants will not know whether they are taking the active or sham treatment. Participants will be asked to complete questionnaires rating their pain levels for a week after chemotherapy. They will also be monitored for safety. It is hoped that gabapentin will reduce the aches and pains in muscles and joints which are commonly experienced by women receiving the chemotherapy drug, docetaxel.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria8

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

Exclusion Criteria5

  • 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)
  • Regular use of analgesia (other than for post operative pain)
  • Epilepsy or seizure disorder
  • Metastatic disease

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Gabapentin 300mg three times a day, orally. Starting the day before chemotherapy, for 6 days in total. The chemotherapy is given every three weeks thus there will be a three week wash out period betw

Gabapentin 300mg three times a day, orally. Starting the day before chemotherapy, for 6 days in total. The chemotherapy is given every three weeks thus there will be a three week wash out period between the intervention and placebo arms. The expected time of elimination of gabapentin is 31.5 hours.


Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611000666921