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Hyperimmune Colostrum and Oral Mucositis (Mucositis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00699569
Recruitment Status : Unknown
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 18, 2008
Last Update Posted : July 23, 2008
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dietary Supplement: hyperimmune colostrum Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : July 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Patients receiving active investigational product
Dietary Supplement: hyperimmune colostrum
hyperimmune colostrum

Placebo Comparator: 2
Patients receiving Placebo
Dietary Supplement: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00699569

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

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Sourasky Medical Center
Tel-Aviv, Israel
Contact: Nachum Vaisman, Prof'    972-3-697-4807   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
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Responsible Party: Nachum Vaisman Prof', Tel-Aviv Sourasky Medical Center Identifier: NCT00699569    
Other Study ID Numbers: TASMC-08-NV-248
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: July 23, 2008
Last Verified: June 2008
Keywords provided by Tel-Aviv Sourasky Medical Center:
hyperimmune colostrum
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases