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Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain

Primary Purpose

Cancer Pains

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Increasing the Controlled-Release Oxycodone dose frequency
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pains focused on measuring Opioid, Refractory Pain, dose frequency, nausea, vomit, dizziness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Opioid naïve or tolerate patients with moderate to severe cancer pain (NRS≥4). Opioid naïve includes patients who are not chronically receiving opioid analgesic on a daily basis and therefore have not developed significant tolerance. The FDA identifies tolerance as receiving at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
  • Age≥18 years old
  • The effect of antitumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) on analgesia can be excluded during the period of analgesic drug dose adjustments
  • Patients can well communicate and cooperate with doctors, understand the therapeutic schemes, agree to attend the study and signed the informed consent form.

Exclusion Criteria:

  • Allergic to research drugs
  • Pain of noncancerous or unknown cause, such as osteoarthritis pain, low back pain, etc.
  • Acute pain
  • Patients receiving radiotherapy or chemotherapy during the period of the treatment
  • No defecation in the first 3 days before enrollment
  • Patients with opioid contraindication: Respiratory inhibition; head damage; paralytic bowel obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia.
  • Use of monoamine oxidase inhibitors within 1 week before enrollment
  • Abnormal laboratory indexes with obvious clinical significance: creatinine beyond two times of the upper limit of normal value;ALT or AST beyond 2.5 times of the upper limit of normal value (For patients with liver metastasis, ALT or AST beyond 5 times of the upper limit of normal value); Liver function Child grade C
  • Acute abdominal disease or accept surgical procedures which may cause gastrointestinal stricture, blind loop or gastrointestinal obstruction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    controlled-release oxycodone group

    Arm Description

    Patients with moderate to severe pain accept CR oxycodone treatment and if any follow situations appears, then change the dose frequency from every 12 hours to every 8 hours or 6 hours. Patients are satisfied with the pain control, but unable to tolerate nausea、vomit or dizziness, and can't get satisfactory pain control if reducing the CR oxycodone dose. Patients are unsatisfied with the pain control, but can't increase the CR oxycodone dose because of intolerable nausea、vomit or dizziness.

    Outcomes

    Primary Outcome Measures

    The effective rate of treatment
    At study entry, assess the adverse drug reaction (ADR) and the pain degree by Likert scale everyday. The Likert scale of pain includes the absence of pain (a score of 0), mild pain (a score of 1), moderate pain (a score of 2), severe pain (a score of 3). The Likert scale of ADR includes the absence of ADR (a score of 0), mild ADR (a score of 1), moderate ADR (a score of 2), severe ADR (a score of 3). The effective rate of treatment: the rate of patients who get satisfactory pain control (0 or 1 point on the 3-point Likert scale ) without intolerable adverse event (0 or 1 point on the 3-point Likert scale ) in two consecutive day .

    Secondary Outcome Measures

    The time of reach effective treatment
    Effective treatment means patients who get satisfactory pain control (0 or 1 point on the 3-point Likert scale ) without intolerable adverse event (0 or 1 point on the 3-point Likert scale ) in two consecutive day .
    The degree of pain reduction
    Apply the Likert scale to evaluate pain degree. The Likert scale of pain includes the absence of pain (a score of 0), mild pain (a score of 1), moderate pain (a score of 2), severe pain (a score of 3).
    The incident rate of adverse drug reaction
    The reduction rate of adverse drug reaction
    Oxycodone blood concentration monitoring
    The blood samples are collected before and after changing the oxycodone dose frequency,For the patients whose frequency change from every 12 hours to every 8 hours ,the blood sampling time points are one hour before changing dose and one hour ,four hour after changing dose, For the patients whose frequency change from every 12 hours to every 6 hours ,the blood sampling time points are one hour before changing dose and one hour ,three hour after changing dose
    Detection of patient's peripheral blood gene
    The blood samples are collected before change the oxycodone dose frequency, and apply the Next-generation sequencing technology to check patient's peripheral blood geneblood gene

    Full Information

    First Posted
    June 28, 2018
    Last Updated
    March 4, 2021
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03639415
    Brief Title
    Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain
    Official Title
    Phase II Study of Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    There is no fund to support
    Study Start Date
    October 30, 2018 (Anticipated)
    Primary Completion Date
    October 30, 2020 (Anticipated)
    Study Completion Date
    March 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Many patients with cancer experience moderate to severe pain that requires treatment with strong opioids, of which oxycodone and morphine are examples, they are widely applied in clinical treatment because of sustained-released formulation can reduce dosing frequency. Goal of pain management is get adequate analgesia and minimize the adverse event at the same time, but in fact there are about 10%-30% patients can't get adequate analgesia because of intolerable adverse event. The common adverse event of Controlled-Release Oxycodone(CR Oxycodone ) are nausea (29.9%)、constipation (25.4%)、dizziness(22.4%) and vomit(11.9%),about 32.8% patients treatment was discontinued because of these adverse event. The peak concentration of opioid is related to adverse event, while the valley concentration is correlated to the analgesic effect. Therefore, if we keep the daily dose while increase the dose frequency so that reduce the single dose, it's will help to avoid intolerable adverse event caused by excessive opioid peak concentration and keep the opioid analgesia at the same time. It's a reasonable way to solve the side effects of opioid. In order to explore the effect of change the dosing frequency of CR Oxycodone to treat refractory pain, pre-experiment have done by several clinical centrals in Fujian province. Preliminary results show that for the patients who can't accept the current opioid dose because of intolerable side effect, changing the dosing frequency is a safe and effect way.
    Detailed Description
    This is a multicenter、singe arm、prospective study. Study population: Moderate to severe cancer pain (4-6 on the standard Numerical Rating Scale [NRS], range 0-10) patients with unsatisfactory pain control because of intolerable nausea、vomit or dizziness during accept CR Oxycodone treatment. Therapeutic schemes: CR oxycodone dose titration scheme: adjusting the dose of CR oxycodone every 24 hours according to the NRS and adverse event; Increasing the dose frequency scheme; Patients with moderate to severe pain accept CR oxycodone treatment and if any follow situations appears, then change the dose frequency from every 12 hours to every 8 hours or 6 hours. Patients are satisfied with the pain control, but unable to tolerate nausea、vomit or dizziness, and can't get satisfactory pain control if reducing the CR oxycodone dose. Patients are unsatisfied with the pain control, but can't increase the CR oxycodone dose because of intolerable nausea、vomit or dizziness. Primary end point: The effective rate of treatment: the rate of patients who get satisfactory pain control without intolerable adverse event in two consecutive day . Secondary end point: The time of reach effective treatment; The degree of pain reduction; The incident rate of adverse drug reaction The reduction rate of adverse drug reaction The change of plasm concentration after change the dose frequency; The relationship between peripheral blood gene and analgesia effect; The relationship between peripheral blood gene and adverse event;

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pains
    Keywords
    Opioid, Refractory Pain, dose frequency, nausea, vomit, dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    controlled-release oxycodone group
    Arm Type
    Experimental
    Arm Description
    Patients with moderate to severe pain accept CR oxycodone treatment and if any follow situations appears, then change the dose frequency from every 12 hours to every 8 hours or 6 hours. Patients are satisfied with the pain control, but unable to tolerate nausea、vomit or dizziness, and can't get satisfactory pain control if reducing the CR oxycodone dose. Patients are unsatisfied with the pain control, but can't increase the CR oxycodone dose because of intolerable nausea、vomit or dizziness.
    Intervention Type
    Drug
    Intervention Name(s)
    Increasing the Controlled-Release Oxycodone dose frequency
    Intervention Description
    Keep the daily dose while increase the dose frequency of Controlled-Release Oxycodone so that reduce the single dose
    Primary Outcome Measure Information:
    Title
    The effective rate of treatment
    Description
    At study entry, assess the adverse drug reaction (ADR) and the pain degree by Likert scale everyday. The Likert scale of pain includes the absence of pain (a score of 0), mild pain (a score of 1), moderate pain (a score of 2), severe pain (a score of 3). The Likert scale of ADR includes the absence of ADR (a score of 0), mild ADR (a score of 1), moderate ADR (a score of 2), severe ADR (a score of 3). The effective rate of treatment: the rate of patients who get satisfactory pain control (0 or 1 point on the 3-point Likert scale ) without intolerable adverse event (0 or 1 point on the 3-point Likert scale ) in two consecutive day .
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    The time of reach effective treatment
    Description
    Effective treatment means patients who get satisfactory pain control (0 or 1 point on the 3-point Likert scale ) without intolerable adverse event (0 or 1 point on the 3-point Likert scale ) in two consecutive day .
    Time Frame
    2 years
    Title
    The degree of pain reduction
    Description
    Apply the Likert scale to evaluate pain degree. The Likert scale of pain includes the absence of pain (a score of 0), mild pain (a score of 1), moderate pain (a score of 2), severe pain (a score of 3).
    Time Frame
    2 years
    Title
    The incident rate of adverse drug reaction
    Time Frame
    2 years
    Title
    The reduction rate of adverse drug reaction
    Time Frame
    2 years
    Title
    Oxycodone blood concentration monitoring
    Description
    The blood samples are collected before and after changing the oxycodone dose frequency,For the patients whose frequency change from every 12 hours to every 8 hours ,the blood sampling time points are one hour before changing dose and one hour ,four hour after changing dose, For the patients whose frequency change from every 12 hours to every 6 hours ,the blood sampling time points are one hour before changing dose and one hour ,three hour after changing dose
    Time Frame
    2 years
    Title
    Detection of patient's peripheral blood gene
    Description
    The blood samples are collected before change the oxycodone dose frequency, and apply the Next-generation sequencing technology to check patient's peripheral blood geneblood gene
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Opioid naïve or tolerate patients with moderate to severe cancer pain (NRS≥4). Opioid naïve includes patients who are not chronically receiving opioid analgesic on a daily basis and therefore have not developed significant tolerance. The FDA identifies tolerance as receiving at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Age≥18 years old The effect of antitumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) on analgesia can be excluded during the period of analgesic drug dose adjustments Patients can well communicate and cooperate with doctors, understand the therapeutic schemes, agree to attend the study and signed the informed consent form. Exclusion Criteria: Allergic to research drugs Pain of noncancerous or unknown cause, such as osteoarthritis pain, low back pain, etc. Acute pain Patients receiving radiotherapy or chemotherapy during the period of the treatment No defecation in the first 3 days before enrollment Patients with opioid contraindication: Respiratory inhibition; head damage; paralytic bowel obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia. Use of monoamine oxidase inhibitors within 1 week before enrollment Abnormal laboratory indexes with obvious clinical significance: creatinine beyond two times of the upper limit of normal value;ALT or AST beyond 2.5 times of the upper limit of normal value (For patients with liver metastasis, ALT or AST beyond 5 times of the upper limit of normal value); Liver function Child grade C Acute abdominal disease or accept surgical procedures which may cause gastrointestinal stricture, blind loop or gastrointestinal obstruction.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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