Hyperimmune Colostrum and Oral Mucositis

NCT ID: NCT00699569

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Keywords

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hyperimmune colostrum mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Patients receiving active investigational product

Group Type EXPERIMENTAL

hyperimmune colostrum

Intervention Type DIETARY_SUPPLEMENT

hyperimmune colostrum

2

Patients receiving Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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hyperimmune colostrum

hyperimmune colostrum

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Principal Investigators

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Nachum Vaisman, Prof'

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nachum Vaisman, Prof'

Role: CONTACT

Phone: 972-3-697-4807

Email: [email protected]

Facility Contacts

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Nachum Vaisman, Prof'

Role: primary

Other Identifiers

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0248-08-TLV

Identifier Type: -

Identifier Source: secondary_id

TASMC-08-NV-248

Identifier Type: -

Identifier Source: org_study_id