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Cancer PainsPhase 4NCT03639415

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

A Phase 4 study of Cancer Pains, run by Fujian Cancer Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Pains
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Oct 2018to 30 Mar 2021
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

About this study

Official title: Phase II Study of Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain

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.

Read the 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:

  1. CR oxycodone dose titration scheme: adjusting the dose of CR oxycodone every 24 hours according to the NRS and adverse event;
  2. 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;

Conditions
Cancer Pains
Being tested
Increasing the Controlled-Release Oxycodone dose frequency
Keywords
Opioid, Refractory Pain, dose frequency, nausea, vomit, dizziness
Medical subject headings
Cancer Pain, Pain, Intractable, Nausea, Vomiting, Dizziness

What participants receive

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

  • Increasing the Controlled-Release Oxycodone dose frequencyDrug

    Keep the daily dose while increase the dose frequency of Controlled-Release Oxycodone so that reduce the single dose

Study groups in NCT03639415
Study groupRoleWhat they receive
controlled-release oxycodone groupExperimentalPatients 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. 1. 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. 2. Patients are unsatisfied with the pain control, but can't increase the CR oxycodone dose because of intolerable nausea、vomit or dizziness.
Receives: Drug: Increasing the Controlled-Release Oxycodone dose frequency

What is being measured

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

  1. 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 .

    Measured: 2 years

Secondary outcomes (6)

  1. 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 .

    Measured: 2 years

  2. 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).

    Measured: 2 years

  3. The incident rate of adverse drug reaction

    Measured: 2 years

  4. The reduction rate of adverse drug reaction

    Measured: 2 years

  5. 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

    Measured: 2 years

  6. 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

    Measured: 2 years

Timeline

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

  1. First posted21 Aug 2018
  2. Study start30 Oct 2018 (estimated)
  3. Primary completion30 Oct 2020 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Why it stopped: There is no fund to support

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639415
Sponsor's protocol ID
FNF010
Status last verified
Jun 2018
First submitted
28 Jun 2018
Last updated
8 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Cancer Pains, run by Fujian Cancer Hospital.

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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

The effective rate of treatment (time frame: 2 years). 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 NCT03639415.

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 2021.

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