Hyperimmune Colostrum and Oral Mucositis

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: hyperimmune colostrum; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00699569

0248-08-TLV

TASMC-08-NV-248

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Patients receiving active investigational product

Treatment:

Dietary Supplement: hyperimmune colostrum

2

Placebo Comparator group

Description:

Patients receiving Placebo

Treatment:

Dietary Supplement: Placebo