NCT00289003

Brief Summary

The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy. Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2003

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 17, 2007

Status Verified

May 1, 2006

First QC Date

February 8, 2006

Last Update Submit

January 15, 2007

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.

Secondary Outcomes (4)

  • To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo

  • To assess time before first sign of oral mucositis

  • To evaluate impact of toxicities like patients' pain and swallowing difficulty

  • To assess the safety of the investigational product

Interventions

Soluble beta-1,3/1,6-glucanDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing radiotherapy or chemoradiotherapy for histologically confirmed squamous cell carcinoma of oral cavity or oropharynx (1.8-2.0 Gy/day; 5 days per week, totally 59.4-70 Gy).
  • Normal mucosa at baseline (i.e. Common Toxicity Criteria (CTC) grade 0)
  • \>= 18 years of age
  • Women of childbearing potential must use an adequate contraceptive method and have a negative pregnancy test
  • Written informed consent

You may not qualify if:

  • Patients who will receive hyperfractionated or accelerated radiotherapy
  • History of malignancies within the past five years other than non-melanomatous skin cancers (with the exception of squamous cell carcinoma of the skin) or carcinoma in situ of the cervix
  • Previous neoplasm in the head and neck area, whether malignant or not
  • Previous radiation therapy for head and neck cancer
  • If wound from curative surgery have not healed
  • Patients expected to receive agents that would interfere with the investigator's ability to assess changes in the appearance of the mucositis during the study
  • Use of radiosensitizers
  • History or clinical evidence of active significant acute or chronic diseases that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis
  • Evidence of distant metastatic disease
  • Expected survival of less than 12 months
  • \> grade 3 performance status (WHO grading)
  • Granulocyte count \< 2.000/mm3 and platelet count \< 100,000/mm3
  • Serum creatinine \>= 150 micromol/L
  • Total bilirubin \>= 36 micromol/L, AST \> 3 times the upper normal limit
  • Any subject who, in the opinion of the investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons like e.g. language barriers or mental incapacity
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology

Bonn, 53119, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Royal Marsden Hospital, Head and Neck Unit

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Christopher M Nutting, Dr.med.

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 9, 2006

Study Start

October 1, 2003

Study Completion

July 1, 2006

Last Updated

January 17, 2007

Record last verified: 2006-05

Locations

DE(2)GB(1)