CancerPhase 3NCT00152854
Acetaminophen for Cancer Pain
A Phase 3 study testing Acetaminophen in people with Cancer and Pain, run by University Health Network, Toronto at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2005to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids
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.
Read the 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.
- Being tested
- Acetaminophen, placebo, sugar pill
- Keywords
- cancer pain, acetaminophen, opioids
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
acetaminophen 1g po qid
acetaminophenDrug
acetaminophen 1g po qid for 7 days
placebo, sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| A, 1, acetaminophen | Active comparator | acetaminophen Receives: Drug: Acetaminophen |
| B placebo | Placebo comparator | placebo PO qid Receives: Drug: placebo, sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: post period 2
Secondary outcomes (12)
Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)
Measured: post period 2
drowsiness
Measured: post period 2
constipation
Measured: post period 2
cold sweats
Measured: post period 2
overall sense of well being
Measured: post period 2
Total analgesic consumption in each treatment period
Measured: post period 2
Best and worst pain scores for each treatment period
Measured: post period 2
Pain relief obtained in each treatment period
Measured: post period 2
Effect of pain on functional ability
Measured: post period 2
Strength of preference for acetaminophen versus placebo on a 5-point scale
Measured: post period 2
Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets
Measured: post period 2
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)
Measured: post period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janette Vardy, MD, Principal investigator, University Health Network, University of TorontoDavid Warr, MD, Principal investigator, University Health Network, University of TorontoIan Tannock, MD, PhD, Principal investigator, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152854
- Sponsor's protocol ID
- ACETAPLAC
- Status last verified
- Mar 2016
- First submitted
- 8 Sep 2005
- Last updated
- 8 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids
- ClinicalTrials.gov ID
- NCT00152854
- Acronym / sponsor ID
- ACETAPLAC
- Keywords
- cancer pain, acetaminophen, opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1, acetaminophen | Active comparator | Drug: Acetaminophenacetaminophen |
| B placebo | Placebo comparator | Drug: placebo, sugar pillplacebo PO qid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophenacetaminophen 1g po qid | Drug | A, 1, acetaminophen |
| acetaminophenacetaminophen 1g po qid for 7 days | Drug | A, 1, acetaminophen |
| placebo, sugar pill | Drug | B placebo |
Primary outcome
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
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
12 secondary outcomes
Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)
Time frame: post period 2
drowsiness
Time frame: post period 2
constipation
Time frame: post period 2
cold sweats
Time frame: post period 2
overall sense of well being
Time frame: post period 2
Total analgesic consumption in each treatment period
Time frame: post period 2
Best and worst pain scores for each treatment period
Time frame: post period 2
Pain relief obtained in each treatment period
Time frame: post period 2
Effect of pain on functional ability
Time frame: post period 2
Strength of preference for acetaminophen versus placebo on a 5-point scale
Time frame: post period 2
Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets
Time frame: post period 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janette Vardy, MD principal investigator
University Health Network, University of Toronto
David Warr, MD principal investigator
University Health Network, University of Toronto
Ian Tannock, MD, PhD principal investigator
University Health Network, University of Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen in people with Cancer and Pain, run by University Health Network, Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.