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Completed

NCT Number: NCT01946555

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

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%.

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.

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Key information

Conditions

Tumor Breakthrough Cancer Pain Cancer Pain Neoplasms Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AO Universitaria Policlinico di Modena, Modena, Italia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Morphine

Drug

Fentanyl

Drug

Methadone

Drug

buprenorphine

Drug

Oxycodone

Drug

Hydromorphone

Drug

Tapentadol

Drug

Primary outcomes

  1. Number and duration of episodes of BTcP

    Time frame: 28 days

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

    Time frame: 28 days

  3. Maximum intensity of BTcP

    Time frame: 28 days

Secondary outcomes

  1. Intensity of pain

    Time frame: 28 days

    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;

  2. Effect of the treatments

    Time frame: 28 days

    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

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Acronym: RER

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2013
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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