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Hyperimmune Colostrum and Oral Mucositis (Mucositis)

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
hyperimmune colostrum
Placebo
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring hyperimmune colostrum, mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer.

Exclusion Criteria:

  • Other tumors
  • Non-epithelial tumors
  • Pregnancy
  • Poor functional status

Sites / Locations

  • Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Patients receiving active investigational product

Patients receiving Placebo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 17, 2008
Last Updated
July 22, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00699569
Brief Title
Hyperimmune Colostrum and Oral Mucositis
Acronym
Mucositis
Official Title
The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
hyperimmune colostrum, mucositis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving active investigational product
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients receiving Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
hyperimmune colostrum
Intervention Description
hyperimmune colostrum
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer. Exclusion Criteria: Other tumors Non-epithelial tumors Pregnancy Poor functional status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nachum Vaisman, Prof'
Phone
972-3-697-4807
Email
vaisman@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Phone
972-3-697-4807
Email
vaisman@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'

12. IPD Sharing Statement

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Hyperimmune Colostrum and Oral Mucositis

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