NCT00790322

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P25-P50 for phase_3 head-and-neck-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3 head-and-neck-cancer

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

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

November 11, 2008

Last Update Submit

February 18, 2010

Conditions

Head and Neck CancerOral Mucositis

Keywords

CancerRadiation therapyRadiotherapyOral MucositisSBG

Outcome Measures

Primary Outcomes (1)

  • Compare the proportion of patients in the two arms who develop severe oral mucositis

    During radiation therapy

Study Arms (2)

Active

EXPERIMENTAL
Drug: SBG

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

SBGDRUG

Soluble beta-1,3/1,6-glucan is a solution for oral use

Active
PlaceboOTHER

Solution for oral use

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study. * Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institute Gustave Roussy

Villejuif Cédex, 94805, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitisNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

FR(1)