NCT03045484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 29, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

October 31, 2016

Last Update Submit

November 28, 2017

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinomaOral Mucositis PainOxycodone

Outcome Measures

Primary Outcomes (1)

  • Total Dose of Oxycodone

    Through chemoradiotherapy completion, 3 weeks

Secondary Outcomes (2)

  • Pain Remission Rate

    24 hours

  • Quality-of-Life Index

    Through chemoradiotherapy completion, an average of 2 weaks

Study Arms (2)

The moderate group

EXPERIMENTAL

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 oxycodoneOther: Chemoradiotherapy

The severe group

EXPERIMENTAL

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 oxycodoneOther: Chemoradiotherapy

Interventions

Controlled-release oxycodoneDRUG

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.

Also known as: CRO
The moderate groupThe severe group
ChemoradiotherapyOTHER

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/㎡.

Also known as: Radiotherapy and Chemotherapy
The moderate groupThe severe group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24872680BACKGROUND

  • 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.

    PMID: 21277720BACKGROUND

  • 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.

    PMID: 14647133BACKGROUND

  • 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.

    PMID: 17280915BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

ChemoradiotherapyRadiotherapyDrug Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Rui-Hua Xu, PhD.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Guo, PhD.

CONTACT

86-20-87343380guol201566@163.com

Rui-Hua Xu, PhD.

CONTACT

86-20-87343404xurh@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator;Professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

February 7, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

November 29, 2017

Record last verified: 2017-02

Locations

CN(1)