NCT00156806

Brief Summary

Breast cancer treatment often involved radiation to the breast. A side-effect of this treatment is skin redness, itching and burning. Some patients have quite severe reactions. Our current treatment for this is to avoid any soaps or other skin irritants and to use a moisturizing cream once all radiation is finished. Aloe vera is believed by many people to be useful for treatment of skin burns but this has never been proven in a randomized study. The aim of this study is to compare aloe vera gel versus plan gel versus the standard treatment to determine if there is any benefit. If there was a benefit of gel treatment over standard it could make radiation treatments more tolerable for cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

September 7, 2005

Last Update Submit

January 23, 2017

Conditions

Breast Cancer

Keywords

aloeradiation dermatitisradiation therapy

Outcome Measures

Primary Outcomes (1)

  • Skin reaction severity.

Secondary Outcomes (1)

  • Symptom severity.

Interventions

Aloe barbadensis topical application in a moisturizing cream vehicle.PROCEDURE

Eligibility Criteria

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

You may qualify if:

  • adult age women receiving 4500cGy or 5000cGy for non-metastatic breast cancer.
  • tumor bed boost allowed.

You may not qualify if:

  • patients with uncontrolled diabetes, uncontrolled eating disorder, acquired immunodeficiency syndrome, active lupus or scleroderma, a known allergy to pure aloe gel, a pre-study contact dermatitis to study creams.
  • consenting procedures not completed prior to 10cGy of radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsRadiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDermatitisRadiation InjuriesWounds and Injuries

Study Officials

  • Donna L. Hoopfer, PhD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

March 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2006

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

CA(1)