NCT00207324

CompletedPhase 3

The Use of Silver Leaf Dressing in the Prevention of Radioth...

British Columbia Cancer Agency Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

R03-0030

Study Type

interventional

Reported enrollment (type unavailable)

100

Locations

1 country

Sites

1

Timeline

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

January 2007

Actual (reported)

Brief Summary

The hypothesis is that silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy. The secondary hypothesis is that silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 100 participants
Study completion date: January 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 15, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Study Completion
January 2007
Actual (reported)

Last Updated: June 27, 2007
Status Verified: June 2007
Last Update Submitted: June 26, 2007

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

silver leaf nylon dressing reduces the percentage of patients developing brisk erythema and moist desquamation while undergoing whole breast radiotherapy

Secondary Outcomes (1)

silver leaf nylon dressing reduces breast-related symptoms of pain, itching and burning sensation in patients receiving whole breast radiotherapy

Interventions

Silver Leaf DressingDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Women diagnosed with completely excised stage I or II invasive breast cancer, or DCIS, who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy will be eligible for this study if they are at increased risk of radiodermatitis at the inframammary fold due to breast size or shape (i.e at least 2cm of skin apposition at the inframammary fold, and/or brassiere cup size C or greater).
Patients undergoing nodal radiotherapy are eligible if criterion 1 is met

Sponsors & Collaborators

Canadian Breast Cancer Foundation
Othercollaborator
British Columbia Cancer Agency
Otherlead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Christina Parsons, MD
British Columbia Cancer Agency
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 21, 2005

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

January 2007

Actual (reported)

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Patients undergoing boost radiotherapy are eligible if criterion 1 is met, but only if the boost volume does not include any part of the breast inferior to the nipple line

Patients may be entered into other local or national trials unless these involve an alteration to standard skin care or altered breast radiotherapy technique

You may not qualify if:

inability to give informed consent
inability to comply with experimental arm of trial
failure of healing of the surgical scar or significant post-operative infection of the wound
prior radiotherapy to either breast or to the chest
presence of significant connective tissue disease (e.g. systemic sclerosis, systemic lupus erythematosis)
known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc)
inability to return for assessment at one week following completion of radiotherapy
allergy to silver

Contact the study team to confirm eligibility.

Last Updated

June 27, 2007

Record last verified: 2007-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00207324
Data provider: ClinicalTrials.gov
Source updated: 2007-06-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:45 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations