Nutrition DisordersPhase 2NCT02309437

Early Use of Opioid in Radiation Mucositis

A Phase 2 study testing Oxycodone in people with Nutrition Disorders and Quality of Life, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 4 sites in China.

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

This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nutrition Disorders, Quality of Life
What is being tested?: Oxycodone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 4 sitesChina
Study dates: 1 Jan 2015to 31 Dec 2017
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological confirmed nasopharyngeal carcinoma;
Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake;
Plan to receive radical radiation therapy, newly to radiation for head and neck;
Aged older or equal to 18 years old;
Could understand and cooperate to accomplish pain evaluation and observation scales;
Sufficient liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5* upper limit of normal (ULN), serum creatinine less than 1.5*ULN;

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Without other serious critical organ dysfunction, such as heart or lung dysfunction;
Performance status (PS) score less than 2;
Voluntary to participate and sign informed consent document;
Obey the rules of trail; could be followed-up on time.

Who cannot join

Excluded by inclusion criteria;
Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine;
Unable to complete the follow-up;
Severe uncontrollable infections of medical disorders;
Major organ including heart, lung, kidney, or liver dysfunction;
With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Cancer Center Of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, 510000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
People's Hospital of Boluo County
Huizhou, Guangdong, 516148

Other trials in China

About this study

Official title: Influences on the Nutrition Statuses and Clinical Outcomes of Early Use of Opioid to Control Local Mucosa Pain Induced by Irradiation in Nasopharyngeal Carcinoma Patients

This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients.

Read the detailed description

The present study is a prospective, randomizing, case-controlled, multi-center clinical trial. 174 firstly diagnosed nasopharyngeal carcinoma patients who need radical radiation therapy will be randomly divided into either early intervention or common intervention group. oxycodone control release tablets will be used to control the pain caused by radiation oral mucositis when the pain level is mild or moderate, respectively. The primary outcome measurement is nutrition status. Quality of life (QOL), the clinical outcomes, and the adverse effects are also to be observed.

Conditions: Nutrition Disorders, Quality of Life
Being tested: Oxycodone
Keywords: Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis
Medical subject headings: Nutrition Disorders, Nasopharyngeal Carcinoma, Pain

What participants receive

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

OxycodoneDrug
Also called OxyContin
Use oxycodone to treat patients with mild pain caused by radiation mucositis.
OxycodoneDrug
Also called OxyContin
Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.

Study groups in NCT02309437
Study group	Role	What they receive
Mild group	Experimental	Use oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose. Receives: Drug: Oxycodone
Moderate group	Active comparator	Use oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose. Receives: Drug: Oxycodone

What is being measured

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

Body Mass Index (BMI)
Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Secondary outcomes (7)

Numeric rating scale (NRS)
NRS refers to the number 0-10 to indicate the degree of pain, 0 is painless and 10 is the most painful.
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Hemoglobin
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Albumin
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Quality of life score
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Dizziness
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Nausea/vomiting
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Somnolence
Measured: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

Timeline

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

1 Jan 201531 Dec 2017

First posted5 Dec 2014 (estimated)
Study start1 Jan 2015
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nutrition DisordersStudies 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: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02309437
Sponsor's protocol ID: PAIN-1
Status last verified: Jul 2018
First submitted: 29 Nov 2014
Last updated: 17 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nutrition Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influences on the Nutrition Statuses and Clinical Outcomes of Early Use of Opioid to Control Local Mucosa Pain Induced by Irradiation in Nasopharyngeal Carcinoma Patients
ClinicalTrials.gov ID: NCT02309437
Acronym / sponsor ID: PAIN-1
Conditions: Nutrition Disorders, Quality of Life
Keywords: Nasopharyngeal carcinoma, Pain, Oxycodone, Opioids, Radiation mucositis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2015 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 5 Dec 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.

This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mild group	Experimental	Drug: OxycodoneUse oxycodone when pain is mild level. Start from 10 mg every 12 hours and titrate for appropriate dose.
Moderate group	Active comparator	Drug: OxycodoneUse oxycodone when pain is moderate or severe level. Start from 10 mg every 12 hours and titrate for appropriate dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histological confirmed nasopharyngeal carcinoma;
Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake;
Plan to receive radical radiation therapy, newly to radiation for head and neck;
Aged older or equal to 18 years old;
Could understand and cooperate to accomplish pain evaluation and observation scales;

Key exclusion criteria (6 listed)

Excluded by inclusion criteria;
Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine;
Unable to complete the follow-up;
Severe uncontrollable infections of medical disorders;
Major organ including heart, lung, kidney, or liver dysfunction;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxycodoneAlso: OxyContinUse oxycodone to treat patients with mild pain caused by radiation mucositis.	Drug	Mild group
OxycodoneAlso: OxyContinUse oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.	Drug	Moderate group

Primary outcome

Body Mass Index (BMI)
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Body mass index (BMI, kg/m2) was defined as the body mass (kg) divided by the square of the body height (m).

7 secondary outcomes

Numeric rating scale (NRS)
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Hemoglobin
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Albumin
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Quality of life score
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Dizziness
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Nausea/vomiting
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.
Somnolence
Time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.

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 Jul 2018.
Individual participant dataSharing planned: No

Related trials for Nutrition Disorders

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density

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.

Dong-ping Chen, M. D. study chair

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Bin Qi, M. D. study director

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxycodone in people with Nutrition Disorders and Quality of Life, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 4 sites in China.

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 10 inclusion and 6 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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?

Body Mass Index (BMI) (time frame: Participants will be followed for the duration of radiotherapy, an expected average of 7 weeks.). 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 NCT02309437.

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 Jul 2018.