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Trial record 36 of 665 for:    OXYCODONE

Comparison of Oxycodone to Control Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy

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ClinicalTrials.gov Identifier: NCT03045484
Recruitment Status : Unknown
Verified February 2017 by Ling Guo, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ling Guo, Sun Yat-sen University

Brief Summary:

Background:Although concurrent chemoradiotherapy is effective for improving disease-free survival and overall survival in patients with locally advanced nasopharyngeal carcinoma. However,the oral mucositis pain evoked by the chemoradiotherapy itself reduces food intake and frequently halts the treatment. Thus, pain control is an important problem in chemoradiotherapy for nasopharyngeal carcinoma.We performed to examine whether early induction of low-dose, opioid from moderate pain reduced total dose of Oxycodone during chemoradiotherapy, while improves the quality of life and reduce weight loss.

Objective:Present clinical trial to investigate the early introduction of opioids suppressed the transient increase in the numeric rating scales(NRS) score for pain and compared with conventional treatment.

Methodology:The subjects will recruit 70 patients who were hospitalized for nasopharyngeal carcinoma. 70 patients were divided into two groups, depending on whether the pain was moderate or severe when an opioid was introduced.Differences between groups were compared using T test protected least significant difference for one-factor analysis of variance. All statistical analyses were performed using SPSS(Statistic Package for Social Science) software.P-values < 0.05 were considered statistically significant.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Controlled-release oxycodone Other: Chemoradiotherapy Not Applicable

Detailed Description:

Controlled-release oxycodone (CRO) was used in this study. The patients kept a daily record of the intensity of pain. CRO is effective for 12 h, so that the patient takes it only twice a day.The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 20 mg. Thus, we began at a dose of 20 mg by default. When the pain worsened, the dose was quickly titrated.When a patient who was suffering from moderate pain in the mouth, pharynx, or larynx consented to take oxycodone, oxycodone was begun at the level of moderate pain. We called this the mild group. In contrast, those patients who did not ask for oxycodone until the pain reached a severe level were called the severe group. Because all patients agreed to use an opioid at some point, the patients were classified into two groups, moderate and severe, according to when the opioid was introduced.

Total dose of oxycodone was defined as the total dose of oxycodone taking during the treatment of chemoradiotherapy. Pain Remission Rate was defined as pain remission after 24h from the start of opioid administration.Evaluating quality of life were conducted once every two weeks.We also evaluated the weight loss as parameters for food intake once a week,until the radiotherapy.All statistical analyses were performed using SPSS software.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The moderate group
Patient who was suffering from moderate pain in the mouth, pharynx, or larynx during the treatment of chemoradiotherapy consented to take controlled-release oxycodone, oxycodone was begun at the level of mild pain. We called this the moderate group. Controlled-release oxycodone was used to relieve oral mucositis pain induced by chemoradiotherapy in this group.
Drug: Controlled-release oxycodone
CRO is effective for 12 h. Patient takes it only twice a day. The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 10 mg.
Other Name: CRO

Other: Chemoradiotherapy
Radiotherapy were administered intensity modulated radiation therapy wiht a dose of 1.8-2.2Gy per fraction, 30-32 fraction for various tumor locations. Chemotherapy drugs platinum was used once a weak with 100mg/㎡.
Other Name: Radiotherapy and Chemotherapy

Experimental: The severe group
Patients who did not ask for controlled-release oxycodone until the pain reached a moderate level during the treatment of chemoradiotherapywere called the severe group. Controlled-release oxycodone was also used to relieve oral mucositis pain induced by chemoradiotherapy in this group..
Drug: Controlled-release oxycodone
CRO is effective for 12 h. Patient takes it only twice a day. The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 10 mg.
Other Name: CRO

Other: Chemoradiotherapy
Radiotherapy were administered intensity modulated radiation therapy wiht a dose of 1.8-2.2Gy per fraction, 30-32 fraction for various tumor locations. Chemotherapy drugs platinum was used once a weak with 100mg/㎡.
Other Name: Radiotherapy and Chemotherapy




Primary Outcome Measures :
  1. Total Dose of Oxycodone [ Time Frame: Through chemoradiotherapy completion, 3 weeks ]

Secondary Outcome Measures :
  1. Pain Remission Rate [ Time Frame: 24 hours ]
  2. Quality-of-Life Index [ Time Frame: Through chemoradiotherapy completion, an average of 2 weaks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Age 18 to 65 years.

    • Patients of both genders must be willing to practice birth control from the time of enrollment on this study.
    • Participants with treatment- Chemoradiotherapy advanced Nasopharyngeal carcinoma.
    • Participants with the ability to assess the pain level.
    • Never use a opioid before treatment.
    • Hematology:

WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L,Hb≥90g/L.

Exclusion Criteria:

  • •Patients do not conform to the inclusion criteria.

    • Refuse to use of opioid drugs.
    • Nasopharyngeal patients with mental illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045484


Contacts
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Contact: Ling Guo, PhD. 86-20-87343380 guol201566@163.com
Contact: Rui-Hua Xu, PhD. 86-20-87343404 xurh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ling Ling, Ph.D.    86-20-87343404    guol201566@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Rui-Hua Xu, PhD. Sun Yat-sen University

Publications:
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Responsible Party: Ling Guo, Principal Investigator;Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03045484     History of Changes
Other Study ID Numbers: B2015-058-01
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ling Guo, Sun Yat-sen University:
nasopharyngeal carcinoma
Oral Mucositis Pain
Oxycodone
Additional relevant MeSH terms:
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Oxycodone
Carcinoma
Nasopharyngeal Carcinoma
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents