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
  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:


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 April 17, 2014