Hyperimmune Colostrum and Oral Mucositis

This study is not yet open for participant recruitment.

Verified by Tel-Aviv Sourasky Medical Center, June 2008

First Received: June 17, 2008 Last Updated: July 22, 2008 History of Changes

Sponsored by:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00699569

Purpose

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.

Condition	Intervention
Head and Neck Cancer	Dietary Supplement: hyperimmune colostrum Dietary Supplement: Placebo

MedlinePlus related topics: Cancer Dietary Supplements Diets Head and Neck Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving active investigational product	Dietary Supplement: hyperimmune colostrum hyperimmune colostrum
2: Placebo Comparator Patients receiving Placebo	Dietary Supplement: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699569

Contacts

Contact: Nachum Vaisman, Prof'

972-3-697-4807

vaisman@tasmc.health.gov.il

Locations

Israel
Sourasky Medical Center
Tel-Aviv, Israel

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Nachum Vaisman, Prof'

Tel-Aviv Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Tel-Aviv Sourasky Medical Center ( Nachum Vaisman Prof' )
Study ID Numbers:	TASMC-08-NV-248, 0248-08-TLV
Study First Received:	June 17, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00699569 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

hyperimmune colostrum
mucositis

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomatitis

Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009