NCT00699569

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 23, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 17, 2008

Last Update Submit

July 22, 2008

Conditions

Head and Neck Cancer

Keywords

hyperimmune colostrummucositis

Study Arms (2)

1

EXPERIMENTAL

Patients receiving active investigational product

Dietary Supplement: hyperimmune colostrum

2

PLACEBO COMPARATOR

Patients receiving Placebo

Dietary Supplement: Placebo

Interventions

hyperimmune colostrumDIETARY_SUPPLEMENT

hyperimmune colostrum

1
PlaceboDIETARY_SUPPLEMENT
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer.

You may not qualify if:

  • Other tumors
  • Non-epithelial tumors
  • Pregnancy
  • Poor functional status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMucositis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Nachum Vaisman, Prof'

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nachum Vaisman, Prof'

CONTACT

972-3-697-4807vaisman@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 23, 2008

Record last verified: 2008-06

Locations

IL(1)