Breakthrough PainCP073NCT02050503
Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
An observational study of Breakthrough Pain and Mucositis, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.
Trial summary
An open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breakthrough Pain, Mucositis, Radiotherapy
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Jun 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults of either sex and over 18 and under 75 years of age, receiving continued treatment with long half-life or controlled release opioids, experiencing breakthrough pain secondary to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.
Who may be able to join
- A histologically confirmed diagnosis of head and neck carcinoma Treatment in the form of radiotherapy or radio-chemotherapy Breakthrough pain related to swallowing (one to four daily episodes) Treatment with controlled release opioids at the time of inclusion: at least 60 mg of morphine sulfate daily, at least 25 microg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily
Who cannot join
- Patients without controlled release opioid treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Alejandro de la Torre. Hospital Puerta de Hierro
Majadahonda, Madrid, 28220
About this study
Official title: Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
An open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain.
Study objectives include assessment of breakthrough pain episodes related with food intake in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck tumors
Read the detailed description
An open, non-randomized study design was used to assess the titration, safety and efficacy of intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in patients with confirmed tolerance of opioid therapy for chronic pain secondary to radiation-induced mucositis. The study plans to include 30 evaluable patients from multiple centers throughout the country. The trial comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated.
- Conditions
- Breakthrough Pain, Mucositis, Radiotherapy, Chemotherapy, Head and Neck Cancer
- Keywords
- Mucositis, Breakthrough pain, Head Nad neck cancer, Intranasal transmucosal fentanyl in pectin
- Medical subject headings
- Breakthrough Pain, Mucositis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intranasal transmucosal fentanyl pectin | intranasal transmucosal fentanyl in pectin (100, 200, 400 or 800 microg) intranasal route titration phase 7 days treatment phase until completing treatment of 12 consecutive episodes of breakthrough pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Difference
Pain Intensity difference: Pain Intensity will be measured 30 min after starting food intake during the screening phase and 30 min after intranasal transmucosal fentanyl in pectin administration/food intake during the treatment phase
Measured: 30 minutes after PecFent administration
Secondary outcomes (1)
number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
The number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication.
Patient rating of drug efficacy measured on a scale from 0 to 10 (0 = ineffective, 10 = totally effective).
Quality of life assessed with the European Organization for Research and Treatment of Cancer quality of life questionnaire -INF025 in its validated Spanish version, administered on the screening visit and at the end of the study.
Patient rating of drug ease of use measured on a scale from 1 to 4 (1 = very complicated, 4 = very simple).
Measured: 12 episodes of breakthrough pain presenting within a maximum of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro De la Torre, MD, Principal investigator, GICOR & Hospital Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050503
- Sponsor's protocol ID
- CP073
- Acronym
- CP073
- Status last verified
- Mar 2015
- First submitted
- 29 Jan 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
- ClinicalTrials.gov ID
- NCT02050503
- Acronym / sponsor ID
- CP073 / CP073
- Conditions
- Breakthrough Pain, Mucositis, Radiotherapy, Chemotherapy, Head and Neck Cancer
- Keywords
- Mucositis, Breakthrough pain, Head Nad neck cancer, Intranasal transmucosal fentanyl in pectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2014 (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.
An open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain.
Study objectives include assessment of breakthrough pain episodes related with food intake in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck tumors
Detailed description
An open, non-randomized study design was used to assess the titration, safety and efficacy of intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in patients with confirmed tolerance of opioid therapy for chronic pain secondary to radiation-induced mucositis. The study plans to include 30 evaluable patients from multiple centers throughout the country. The trial comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intranasal transmucosal fentanyl pectin | – | –intranasal transmucosal fentanyl in pectin (100, 200, 400 or 800 microg) intranasal route titration phase 7 days treatment phase until completing treatment of 12 consecutive episodes of breakthrough pain |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults of either sex and over 18 and under 75 years of age, receiving continued treatment with long half-life or controlled release opioids, experiencing breakthrough pain secondary to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.
Key inclusion criteria (1 listed)
- A histologically confirmed diagnosis of head and neck carcinoma Treatment in the form of radiotherapy or radio-chemotherapy Breakthrough pain related to swallowing (one to four daily episodes) Treatment with controlled release opioids at the time of inclusion: at least 60 mg of morphine sulfate daily, at least 25 microg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily
Key exclusion criteria (1 listed)
- Patients without controlled release opioid treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity Difference
Time frame: 30 minutes after PecFent administration
Pain Intensity difference: Pain Intensity will be measured 30 min after starting food intake during the screening phase and 30 min after intranasal transmucosal fentanyl in pectin administration/food intake during the treatment phase
1 secondary outcome
number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
Time frame: 12 episodes of breakthrough pain presenting within a maximum of 7 days.
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 17 Mar 2015.
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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.
Alejandro De la Torre, MD principal investigator
GICOR & Hospital Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Pain and Mucositis, run by Grupo de Investigación Clínica en Oncología Radioterapia at 1 site in Spain.
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 1 inclusion and 1 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Pain Intensity Difference (time frame: 30 minutes after PecFent administration). 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 17 Mar 2015.