We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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
Head and Neck Cancer Dietary Supplement: hyperimmune colostrum Dietary Supplement: Placebo

Study Design

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

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
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
mucositis

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