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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00699569
Other study ID # TASMC-08-NV-248
Secondary ID 0248-08-TLV
Status Not yet recruiting
Phase N/A
First received June 17, 2008
Last updated July 22, 2008
Start date July 2008
Est. completion date July 2009

Study information

Verified date June 2008
Source Tel-Aviv Sourasky Medical Center
Contact Nachum Vaisman, Prof'
Phone 972-3-697-4807
Email vaisman@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care


Intervention

Dietary Supplement:
hyperimmune colostrum
hyperimmune colostrum
Placebo


Locations

Country Name City State
Israel Sourasky Medical Center Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

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