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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00152854




Registration number
NCT00152854
Ethics application status
Date submitted
8/09/2005
Date registered
9/09/2005
Date last updated
8/03/2016

Titles & IDs
Public title
Acetaminophen for Cancer Pain
Scientific title
A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids
Secondary ID [1] 0 0
ACETAPLAC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Pain 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Acetaminophen
Treatment: Drugs - acetaminophen
Treatment: Drugs - placebo, sugar pill

Active Comparator: A, 1, acetaminophen - acetaminophen

Placebo Comparator: B placebo - placebo PO qid


Treatment: Drugs: Acetaminophen
acetaminophen 1g po qid

Treatment: Drugs: acetaminophen
acetaminophen 1g po qid for 7 days

Treatment: Drugs: placebo, sugar pill
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient preference for the acetaminophen or the placebo arm as assessed by asking the patient whether he/she preferred treatment period 1 or treatment period 2
Timepoint [1] 0 0
Post completion of period 2
Primary outcome [2] 0 0
Differences in the mean pain intensity score as assessed by the daily average Numeric Rating Scale (NRS) pain score during the week given acetaminophen compared with the daily average NRS pain score during the week given placebo
Timepoint [2] 0 0
post period 2
Secondary outcome [1] 0 0
Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)
Timepoint [1] 0 0
post period 2
Secondary outcome [2] 0 0
drowsiness
Timepoint [2] 0 0
post period 2
Secondary outcome [3] 0 0
constipation
Timepoint [3] 0 0
post period 2
Secondary outcome [4] 0 0
cold sweats
Timepoint [4] 0 0
post period 2
Secondary outcome [5] 0 0
overall sense of well being
Timepoint [5] 0 0
post period 2
Secondary outcome [6] 0 0
Total analgesic consumption in each treatment period
Timepoint [6] 0 0
post period 2
Secondary outcome [7] 0 0
Best and worst pain scores for each treatment period
Timepoint [7] 0 0
post period 2
Secondary outcome [8] 0 0
Pain relief obtained in each treatment period
Timepoint [8] 0 0
post period 2
Secondary outcome [9] 0 0
Effect of pain on functional ability
Timepoint [9] 0 0
post period 2
Secondary outcome [10] 0 0
Strength of preference for acetaminophen versus placebo on a 5-point scale
Timepoint [10] 0 0
post period 2
Secondary outcome [11] 0 0
Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets
Timepoint [11] 0 0
post period 2
Secondary outcome [12] 0 0
Proportion of patients having a clinically significant improvement in pain (defined as an improvement in mean NRS of at least 33% during the week taking acetaminophen)
Timepoint [12] 0 0
post period 2

Eligibility
Key inclusion criteria
1. Patients diagnosed with malignancy who have persistent pain which is believed by the
investigator to be due to their cancer, and whose analgesic regimen has been
stabilised on > 60mg of morphine equivalents/day.

2. Age > 18 years

3. Performance status of 0-2 by the European Co-operative Oncology Group (ECOG)
Performance Scale

4. Sufficient English skills to be able to complete the daily diary, BPI and to
understand the consent form

5. Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has no pain (0/10 on NRS).

2. Patients with severe pain are excluded, however once their pain control is optimised
they are eligible.

3. Patient has received radiation therapy in the six weeks prior to commencing the study
or is likely to require radiotherapy during the study period.

4. Patient has commenced, or had dose modifications, to either non-steroidal
anti-inflammatory drugs (NSAIDs) or corticosteroids in the week prior to commencing
the study, or during the two-week study period.

5. Patient has commenced chemotherapy or hormone therapy in the 4 weeks prior to the
study or is expected to commence chemotherapy or hormonotherapy during the study
period. Patients who are stable on long-term chemotherapy or hormones are eligible for
this study. Patients who receive high dose steroids as antiemetics with their
chemotherapy are eligible providing they are not receiving the steroids during the
study period.

6. Patient has a contraindication to acetaminophen.

7. Use of acetaminophen in the 48 hours prior to commencement of the study period.

8. Abnormal laboratory values:

- Absolute neutrophil count < 1.5 X 10^9/L and white blood cell (WBC) count < 3 X
10^9/L

- Platelet count < 100 X 10^9/L

- Liver transaminases > 2.5 X upper limit of normal

- Bilirubin > 1.5 X upper limit of normal

- Creatinine > 1.5 X upper limit of normal

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Cancer Centre - Sydney
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The
addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients
demonstrated better pain control without an increase in side effects. This study will
determine if regular acetaminophen improves pain control when added to strong opioids in
patients with cancer pain.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00152854
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janette Vardy, MD
Address 0 0
University Health Network, University of Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00152854