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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Hyperimmune Colostrum on Radiation-Induce Oral Mucositis of Patients With Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
Patients receiving active investigational product
 Dietary Supplement: hyperimmune colostrum
hyperimmune colostrum
Placebo Comparator: 2
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 Not yet recruiting
Tel-Aviv, Israel
Contact: Nachum Vaisman, Prof'     972-3-697-4807     vaisman@tasmc.health.gov.il    
Principal Investigator: Nachum Vaisman, Prof'            
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: Nachum Vaisman Prof', Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00699569     History of Changes
Other Study ID Numbers: TASMC-08-NV-248, 0248-08-TLV
Study First Received: June 17, 2008
Last Updated: July 22, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
hyperimmune colostrum
mucositis

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
 Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013