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TumorRERNCT01946555

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

An observational study of Tumor and Cancer Pain, run by Mario Negri Institute for Pharmacological Research at 11 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain". Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Tumor, Cancer Pain, Breakthrough Cancer Pain
What is being tested?
Morphine, Fentanyl and Methadone
How many people
150 participants
Where
11 sitesItaly
Study dates
Sep 2013to Dec 2015
Phase
Observational
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study involves a longitudinal evaluation of BTCP in cancer patients with pain, through a follow-up of 4 weeks, which will examine in a dynamic clinical aspects (variation over time of the number and duration of episodes, painful intensity, changes in ATC and rescue therapy).

Who may be able to join

  • diagnosis (histologic or cytologic) of locally advanced cancer and / or metastatic disease;
  • presence of baseline pain of moderate intensity / severe, necessitating treatment with opioids of the 3rd step / WHO, already in progress or to be undertaken at a stage just prior to the start of the study (see also criterion 4 where indicates that "the pain of base must be adequately controlled with opioids of the wHO 3rd step");
  • estimated life expectancy of more than one month;
  • presence of BTCP, diagnosed according to the criteria set by the definition of BTCP and the algorithm of Davies, for which it is established to undertake a treatment "rescue" of painful episodes, with the appropriate opioid drugs at the time of commencement of the study;
  • capable of taking opioid medications for pain basic and breakthrough pain, by any route of administration;
  • aged more than 18 years.

Who cannot join

  • participation in other research projects that are in conflict or could confound the results of the study;
  • absence of informed consent, or withdrawal of consent for study participation;
  • presence of some pathological mental or psychiatric conditions, due to the tumor or concomitant diseases, which interfere with the state of consciousness or the ability to judge the point of jeopardizing the study protocol;
  • need treatment for comorbid conditions present at the beginning of the study that could create potentially dangerous drug interactions with opioids (conazolici use of antifungals or macrolide antibiotics);
  • contraindications of any kind for use of opioid drugs;
  • positivity of a story, past or current, of substance abuse;
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  • inability to ensure regular follow-up;
  • diagnosis of primary tumor of the brain;
  • situation of the presence of BTCP already in treatment with opioid rescue of 3rd step;
  • decision to use drugs "rescue" of different opioid 3rd step / WHO (NSAIDs, opioids of 2 ° step), for the treatment of BTCP;
  • diagnosis of chronic renal failure proclaimed already in place, with values of blood creatinine ≥ 2 mg / dL.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Italy11 sites

  • Azienda USL - Ospedale di Carpi e Mirandola

    Carpi

  • A.O.U. Arcispedale S. Anna

    Ferrara

  • Ospedale di Fiorenzuola D'Arda

    Fiorenzuola d'Arda

  • Ospedale di Lugo

    Lugo

  • IRCCS-IRST Forlì

    Meldola

  • AO Universitaria Policlinico di Modena

    Modena, Italia, 41124

  • A.O. Universitaria Parma

    Parma, Italia

  • Ospedale di Piacenza

    Piacenza

  • Arcispedale S. Maria Nuova Azienda Ospedaliera

    Reggio Emilia

  • Ospedale degli Infermi

    Rimini

  • Ospedale Magati

    Scandiano, Italia

Other trials in Italy

About this study

The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain".

The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer pain). The prevalence of BTcP is equal to 56%.

Read more

Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in the three sub-types: voluntary, non- voluntary and procedural.

The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe changes in the intensity of pain during the day, so it is necessary to differentiate slight fluctuations from the presence of real episodes of BTCP, for which is necessary to use a rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm, present in the literature, to perform the diagnosis of BTCP.

In the presence of BTCP, is important both a correct controlled background pain with major opioids, which can reduce the number and the intensity of the painful episodes, both implement an adjunctive therapy, called "rescue", to be administered at the time which takes over the painful episode using, in this case, an opioid greater.

Being tested
Morphine, Fentanyl, Methadone, Buprenorphine, Oxycodone
Keywords
Breakthrough cancer pain, Neuropathic pain, Major opioid, Analgesics
Medical subject headings
Neoplasms, Cancer Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01946555
Study groupRoleWhat they receive
Worst pain, Average painIt is necessary that patients are treated for their baseline pain with opioid medications 3rd step (WHO guidelines), having seven different provisions molecules (morphine, methadone, fentanyl, buprenorphine, oxycodone, hydromorphone and tapentadol), and that they receive opioid rescue medication, based on free choice among the options available on the market (in the form of transmucosal fentanyl: OTFC - lollipop, buccal buccal tablets, sublingual tablets, nasal spray in aqueous solution, with pectin nasal spray, morphine or other opioid "oral immediate release" or intravenously).
Receives: Drug: Morphine; Drug: Fentanyl; Drug: Methadone; Drug: Buprenorphine; Drug: Oxycodone; Drug: Hydromorphone; Drug: Tapentadol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and duration of episodes of BTcP

    Measured: 28 days

  2. Time to reach the peak of pain in the BTcP

    Measured: 28 days

  3. Maximum intensity of BTcP

    Measured: 28 days

Secondary outcomes (2)

  1. Intensity of pain

    Evaluate the relationship between the intensity of baseline pain in its various dimensions (worst, average and light on the last 24 hours) and intensity of pain reported during episodes of BTCP;

    Measured: 28 days

  2. Effect of the treatments

    Evaluate over time the effect of the treatments on the rescue BTCP, in terms of reduction of the number that the intensity of the episodes of BTCP

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01946555
Sponsor's protocol ID
Studio RER
Acronym
RER
Status last verified
Apr 2016
First submitted
10 Sep 2013
Last updated
14 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Williston Park). 1989 Aug;3(8 Suppl):25-9.

    PubMed 2484297

  • Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990 Jun;41(3):273-281. doi: 10.1016/0304-3959(90)90004-W.

    PubMed 1697056

  • Davies AN. Cancer-related breakthrough pain. Br J Hosp Med (Lond). 2006 Aug;67(8):414-6. doi: 10.12968/hmed.2006.67.8.21960.

    PubMed 16918095

  • Greco MT, Corli O, Montanari M, Deandrea S, Zagonel V, Apolone G; Writing Protocol Committee; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Epidemiology and pattern of care of breakthrough cancer pain in a longitudinal sample of cancer patients: results from the Cancer Pain Outcome Research Study Group. Clin J Pain. 2011 Jan;27(1):9-18. doi: 10.1097/AJP.0b013e3181edc250.

    PubMed 20842024

  • Deandrea S, Corli O, Consonni D, Villani W, Greco MT, Apolone G. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage. 2014 Jan;47(1):57-76. doi: 10.1016/j.jpainsymman.2013.02.015. Epub 2013 Jun 21.

    PubMed 23796584

Questions about this trial

What is this clinical trial studying?

An observational study of Tumor and Cancer Pain, run by Mario Negri Institute for Pharmacological Research at 11 sites in Italy.

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 6 inclusion and 11 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Number and duration of episodes of BTcP (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01946555, which also lists 5 linked publications.

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 14 Apr 2016.

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