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Hyperimmune Colostrum and Oral Mucositis (Mucositis)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: June 17, 2008
Last updated: July 22, 2008
Last verified: June 2008
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00699569

Contact: Nachum Vaisman, Prof' 972-3-697-4807

Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel
Contact: Nachum Vaisman, Prof'    972-3-697-4807   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Nachum Vaisman Prof', Tel-Aviv Sourasky Medical Center Identifier: NCT00699569     History of Changes
Other Study ID Numbers: TASMC-08-NV-248
Study First Received: June 17, 2008
Last Updated: July 22, 2008

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on May 24, 2017