Hyperimmune Colostrum and Oral Mucositis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT00699569

First received: June 17, 2008

Last updated: July 22, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

July 22, 2008

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00699569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hyperimmune Colostrum and Oral Mucositis

Official Title ^ICMJE

The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Dietary Supplement: hyperimmune colostrum
hyperimmune colostrum
Dietary Supplement: Placebo

Study Arm (s)

Experimental: 1
Patients receiving active investigational product

Intervention: Dietary Supplement: hyperimmune colostrum
Placebo Comparator: 2
Patients receiving Placebo

Intervention: Dietary Supplement: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nachum Vaisman, Prof'

972-3-697-4807

vaisman@tasmc.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00699569

Other Study ID Numbers ^ICMJE

TASMC-08-NV-248, 0248-08-TLV

Has Data Monitoring Committee

Responsible Party

Nachum Vaisman Prof', Tel-Aviv Sourasky Medical Center

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nachum Vaisman, Prof'

Tel-Aviv Sourasky Medical Center

Information Provided By

Tel-Aviv Sourasky Medical Center

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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