Acetaminophen for Cancer Pain

NCT ID: NCT00152854

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Cancer; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A, 1, acetaminophen

acetaminophen

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

acetaminophen 1g po qid

acetaminophen

Intervention Type: DRUG

acetaminophen 1g po qid for 7 days

B placebo

placebo PO qid

Group Type: PLACEBO_COMPARATOR

placebo, sugar pill

Intervention Type: DRUG

Interventions

Acetaminophen

acetaminophen 1g po qid

Intervention Type: DRUG

acetaminophen

acetaminophen 1g po qid for 7 days

Intervention Type: DRUG

placebo, sugar pill

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janette Vardy, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

David Warr, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

Ian Tannock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

Locations

Sydney Cancer Centre

Sydney, New South Wales, Australia

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Australia; Canada

Other Identifiers

ACETAPLAC

Identifier Type: -

Identifier Source: org_study_id