Acetaminophen for Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152854
First received: September 8, 2005
Last updated: March 4, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Cancer
Pain
Drug: Acetaminophen
Drug: acetaminophen
Drug: placebo, sugar pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 [ Time Frame: Post completion of period 2 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: post period 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting) [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • drowsiness [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • constipation [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • cold sweats [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • overall sense of well being [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Total analgesic consumption in each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Best and worst pain scores for each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Pain relief obtained in each treatment period [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Effect of pain on functional ability [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Strength of preference for acetaminophen versus placebo on a 5-point scale [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets [ Time Frame: post period 2 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: post period 2 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2005
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A, 1, acetaminophen
acetaminophen
Drug: Acetaminophen
acetaminophen 1g po qid
Drug: acetaminophen
acetaminophen 1g po qid for 7 days
Placebo Comparator: B placebo
placebo PO qid
Drug: placebo, sugar pill

Detailed Description:

Aim:

To assess whether regular oral acetaminophen can reduce pain in cancer patients already on a strong opioid regimen.

Rationale:

It is estimated that 75% of people with advanced cancer suffer significant pain. Many of these people continue to have pain despite being on strong opioids. The rationale behind adding an additional analgesic with a different mechanism of action is to attempt to improve analgesia without increasing side effects.

Overview:

This is a double blind, randomised placebo-controlled, crossover trial to evaluate whether the addition of regular acetaminophen can reduce pain in cancer patients already on a strong opioid regimen. The study will be performed in ambulatory cancer patients who have pain that is believed to be caused by their cancer, and who have already been stabilised on an opioid regimen of > 60mg/day of morphine equivalents. Each patient will be randomly allocated to receive either acetaminophen 1g qid or an identical appearing placebo qid for a seven-day period, and then crossed over to the other arm for a further seven-day period. Patients will complete daily pain diaries and weekly questionnaires (Brief Pain Inventory) and comparison will be made between the pain scores for the two treatment periods. Patient preference for the two treatment periods will also be evaluated.

Research Question:

A randomised, double-blind, placebo controlled crossover trial to determine if the addition of regular acetaminophen (1g PO qid) leads to improved analgesic control in adult cancer patients at Princess Margaret Hospital, who are already on strong opioids (> 60mg morphine equivalents/day) as evaluated by daily pain scores measured by Numerical Rating Scales (NRS) and the Brief Pain Inventory (BPI).

Hypothesis:

Regular acetaminophen improves pain control in cancer patients who are already on strong opioid regimens.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152854

Locations
Australia, New South Wales
Sydney Cancer Centre
Sydney, New South Wales, Australia, 2139
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Janette Vardy, MD University Health Network, University of Toronto
Principal Investigator: David Warr, MD University Health Network, University of Toronto
Principal Investigator: Ian Tannock, MD, PhD University Health Network, University of Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152854     History of Changes
Other Study ID Numbers: ACETAPLAC 
Study First Received: September 8, 2005
Last Updated: March 4, 2016
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
cancer pain
acetaminophen
opioids

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on July 24, 2016