Clinical trial NCT03045484: Comparison of Oxycodone to Control Moderate or Severe Oral Mucositis Pain Induced by Chemoradiotherapy
Official title: Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
Oral Mucositis Pain
Oxycodone
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Total Dose of Oxycodone
timeFrame: Through chemoradiotherapy completion, 3 weeks
Secondary outcomes:
measure: Pain Remission Rate
timeFrame: 24 hours
measure: Quality-of-Life Index
timeFrame: Through chemoradiotherapy completion, an average of 2 weaks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Rui-Hua Xu, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo SP, Wu SG, Zhou J, Feng HX, Li FY, Wu YJ, Sun JY, He ZY. Transdermal fentanyl for pain due to chemoradiotherapy-induced oral mucositis in nasopharyngeal cancer patients: evaluating efficacy, safety, and improvement in quality of life. Drug Des Devel Ther. 2014 May 12;8:497-503. doi: 10.2147/DDDT.S60187. eCollection 2014.
citation: Takase H, Sakata T, Yamano T, Sueta T, Nomoto S, Nakagawa T. Advantage of early induction of opioid to control pain induced by irradiation in head and neck cancer patients. Auris Nasus Larynx. 2011 Aug;38(4):495-500. doi: 10.1016/j.anl.2010.12.012. Epub 2011 Jan 31.
citation: Lauretti GR, Oliveira GM, Pereira NL. Comparison of sustained-release morphine with sustained-release oxycodone in advanced cancer patients. Br J Cancer. 2003 Dec 1;89(11):2027-30. doi: 10.1038/sj.bjc.6601365.
citation: Epstein JB, Epstein JD, Epstein MS, Oien H, Truelove EL. Management of pain in cancer patients with oral mucositis: follow-up of multiple doses of doxepin oral rinse. J Pain Symptom Manage. 2007 Feb;33(2):111-4. doi: 10.1016/j.jpainsymman.2006.11.002. No abstract available.