NCT02075749

Brief Summary

Abstract: Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Mucositis is a major complication of irradiation in head and neck (H\&N) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment. Methods and Materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

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, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

February 26, 2014

Last Update Submit

July 9, 2014

Conditions

Mucositis

Keywords

irradiationmucositistriamcinolone acetonidelicoricemucoadhesive film

Outcome Measures

Primary Outcomes (1)

  • pain score

    at the end of each consecutive week the pain score was recorded.

    4 weeks

Secondary Outcomes (1)

  • mucositis grade

    4 weeks

Other Outcomes (1)

  • quality of life

    4 weeks

Study Arms (3)

triamcinolone acetonide mucoadhesive

ACTIVE COMPARATOR

30 patients received triamcinolone acetonide mucoadhesive films

Drug: Triamcinolone Acetonide

Licorice

EXPERIMENTAL

30 patients received licorice mucoadhesive films

Drug: licorice mucoadhesive films

Mucoadhesive film

PLACEBO COMPARATOR

30 patients received mucoadhesive films without any drug ingredients

Interventions

Triamcinolone AcetonideDRUG
Also known as: made in Germany (Merck)
triamcinolone acetonide mucoadhesive
licorice mucoadhesive filmsDRUG

30 patients received licorice mucoadhesive films

Also known as: AFTOGEL Patch
Licorice

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years of age
  • men and nonpregnant women
  • women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
  • no previous radiation therapy applied in the head and neck
  • medically fit for a course of radical radiotherapy
  • an ability to remain in the study for its entire duration

You may not qualify if:

  • pregnant women
  • women of childbearing potential in whom medically prescribed birth control was not used
  • concurrent chemotherapy
  • history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
  • sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
  • inability to provide informed consent
  • actively bleeding gastric ulcer, severe esophageal reflux
  • major surgery, trauma or burns in the preceding 4 weeks
  • clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omid ( or Sayyed-O-Shohada) Hospital

Isfahan, Isfahan, 8675446355, Iran

Location

MeSH Terms

Conditions

Mucositis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Nasr

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

IR(1)