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

NCT ID: NCT03045484

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-06-30

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; Oral Mucositis Pain; Oxycodone

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Controlled-release oxycodone

Intervention Type: DRUG

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.

Chemoradiotherapy

Intervention Type: OTHER

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/㎡.

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..

Group Type: EXPERIMENTAL

Controlled-release oxycodone

Intervention Type: DRUG

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.

Chemoradiotherapy

Intervention Type: OTHER

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/㎡.

Interventions

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.

Intervention Type: DRUG

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/㎡.

Intervention Type: OTHER

Other Intervention Names

CRO; Radiotherapy and Chemotherapy

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ling Guo

Principal Investigator;Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui-Hua Xu, PhD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Guo, PhD.

Role: CONTACT

Phone: 86-20-87343380

Email: guol201566@163.com

Rui-Hua Xu, PhD.

Role: CONTACT

Phone: 86-20-87343404

Email: xurh@sysucc.org.cn

Facility Contacts

Ling Ling, Ph.D.

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 24872680 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21277720 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14647133 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17280915 (View on PubMed)

Other Identifiers

B2015-058-01

Identifier Type: -

Identifier Source: org_study_id