Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000666921
Ethics application status
Not yet submitted
Date submitted
23/05/2011
Date registered
1/07/2011
Date last updated
1/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Gabapentin for taxane associated acute pain syndrome - randomised, placebo-controlled, crossover trial. The TAPS Trial
Scientific title
In patients receiving docetaxel for early stage breast cancer who experience taxane associated acute pain syndrome is gabapentin better than placebo
for reducing pain?
Secondary ID [1] 260056 0
Nil
Universal Trial Number (UTN)
U1111-1120-9453
Trial acronym
The TAPS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 265721 0
Taxane associated acute pain syndrome 267957 0
Condition category
Condition code
Cancer 265863 265863 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264473 0
Treatment: Drugs
Comparator / control treatment
Placebo, Microcrystalline Cellulose
Control group
Placebo

Outcomes
Primary outcome [1] 266817 0
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
Timepoint [1] 266817 0
Daily for a week after chemotherapy
Secondary outcome [1] 276105 0
To determine the effects of gabapentin on patient reported average pain score, (pain that is new since your last dose of chemotherapy) on a numeric rating scale
Timepoint [1] 276105 0
Daily for a week after chemotherapy
Secondary outcome [2] 276106 0
To determine the effects of gabapentin on usage of other analgesia as reported by the patient
Timepoint [2] 276106 0
During the 3 weeks after chemotherapy
Secondary outcome [3] 276441 0
To determine the effects of gabapentin on adverse events measured by common terminology for adverse events. Particular adverse events for review include pain (pain- other, muscle and joint aches and pains), nausea, fatigue, insomnia, somnolence and dizziness.
Timepoint [3] 276441 0
Daily for a week after chemotherapy
Secondary outcome [4] 276442 0
To determine the effects of gabapentin on patient preference as reported by the patient
Timepoint [4] 276442 0
3 months after the start of chemotherapy.
Secondary outcome [5] 276483 0
To determine the effects of gabapentin on aspects of health related quality of life using 'Patient's Disease and Treatment Assessment Form'
Timepoint [5] 276483 0
At end of week one after each cycle of chemotherpay and at 3 months after the start of chemotherapy.
Secondary outcome [6] 276484 0
Correlative outcome. Patient description of pain using a pain assessment questionniare (specific to taxane pain, from the Mayo clinic)
Timepoint [6] 276484 0
One week after cycle one docetaxel.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table generated by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 4037 0
4029
Recruitment postcode(s) [2] 4038 0
4560
Recruitment postcode(s) [3] 4039 0
4101
Recruitment postcode(s) [4] 4040 0
1402
Recruitment postcode(s) [5] 4041 0
4215
Recruitment postcode(s) [6] 4042 0
4020

Funding & Sponsors
Funding source category [1] 267121 0
Hospital
Name [1] 267121 0
Sunshine Coast Cancer Centre, Nambour General Hospital
Country [1] 267121 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast Cancer Centre, Nambour General Hospital
Address
Hospital Road,
Nambour
QLD
4560
Country
Australia
Secondary sponsor category [1] 264202 0
None
Name [1] 264202 0
Address [1] 264202 0
Country [1] 264202 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 267107 0
Ethics committee address [1] 267107 0
Ethics committee country [1] 267107 0
Date submitted for ethics approval [1] 267107 0
30/05/2011
Approval date [1] 267107 0
Ethics approval number [1] 267107 0

Summary
Brief 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.
Trial website
No website
Trial related presentations / publications
No publications as yet
Public notes

Contacts
Principal investigator
Name 32531 0
Address 32531 0
Country 32531 0
Phone 32531 0
Fax 32531 0
Email 32531 0
Contact person for public queries
Name 15778 0
Christine Cocks
Address 15778 0
Oncology Trials
Nambour General Hospital
Hospital Road
Nambour
QLD
4560
Country 15778 0
Australia
Phone 15778 0
+61 7 5470 6202
Fax 15778 0
+61 7 5470 6343
Email 15778 0
[email protected]
Contact person for scientific queries
Name 6706 0
Dr Kathleen Houston
Address 6706 0
Royal Brisbane and Women's Hospital
Butterfield Street,
Brisbane
QLD
4029
Country 6706 0
Australia
Phone 6706 0
+61736368111
Fax 6706 0
+61732522746
Email 6706 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.