Acetaminophen for Cancer Pain

NCT00152854 | Completed Phase 3

• 1 other identifier: ACETAPLAC
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cancer; Pain

Keywords

cancer pain; acetaminophen; opioids

Outcome Measures

Primary Outcomes (2)

• 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

  Post completion of period 2

• 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

  post period 2

Secondary Outcomes (12)

• Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)

  post period 2

• drowsiness

  post period 2

• constipation

  post period 2

• cold sweats

  post period 2

• overall sense of well being

  post period 2

Study Arms (2)

A, 1, acetaminophen

ACTIVE COMPARATOR

acetaminophen

Drug: Acetaminophen

B placebo

PLACEBO COMPARATOR

placebo PO qid

Drug: placebo, sugar pill

Interventions

acetaminophen DRUG

acetaminophen 1g po qid

A, 1, acetaminophen

placebo, sugar pill DRUG

B placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \> 18 years
• Performance status of 0-2 by the European Co-operative Oncology Group (ECOG) Performance Scale
• Sufficient English skills to be able to complete the daily diary, BPI and to understand the consent form
• Signed informed consent

You may not qualify if:

• Patient has no pain (0/10 on NRS).
• Patients with severe pain are excluded, however once their pain control is optimised they are eligible.
• Patient has received radiation therapy in the six weeks prior to commencing the study or is likely to require radiotherapy during the study period.
• 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.
• 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.
• Patient has a contraindication to acetaminophen.
• Use of acetaminophen in the 48 hours prior to commencement of the study period.
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Sydney Cancer Centre

Sydney, New South Wales, 2139, Australia

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain

Interventions

Acetaminophen; Sugars

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Carbohydrates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

AU (1); CA (1)