Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer

NCT03518489 | Unknown

• 1 other identifier: FujianCH
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.

Conditions

Radiation Induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks

  The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded.

  The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks

Secondary Outcomes (4)

• Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2)

  The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.

• Change from Baseline Quality of Life at 7 weeks

  The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.

• Change from Baseline Karnofsky Performance Status Scale at 7 weeks

  The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks

• The Adverse events Related to lappaconitine

  The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.

Study Arms (2)

Experimental

EXPERIMENTAL

Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy.

Drug: Lappaconitine Adhesive Patch

Control

ACTIVE COMPARATOR

Patients will be given standard care when oral pain is reported

Drug: standard care

Interventions

Lappaconitine Adhesive Patch DRUG

to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain

Also known as: standard care

Experimental

standard care DRUG

Standard care will include mouth wash with antibiotics.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
• Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
• Karnofsky Performance Status Scale between 60-100
• WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
• ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
• Sign the informed consent.

You may not qualify if:

• Younger than 18 years old or older than 70 years old
• Pregnancy or lactation
• Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
• Have suffered from other tumor or now suffering from other tumor
• Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
• Refuse to give up smoking/drinking/betel chewing
• suffering from other active infection diseases and in need of treatment.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shufang Qiu, M.D.

  Fujian Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Jing Huang, master

CONTACT

13375001112; huangjing2567@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 8, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CN (1)