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Investigating the Therapeutic Effectiveness of Aloe Barbadensis in Reducing Cutaneous Side-Effects of Radiation Treatment for Breast Cancer.


Phase 3
18 Years
N/A
Not Enrolling
Female
- Breast Cancer

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Trial Information

Investigating the Therapeutic Effectiveness of Aloe Barbadensis in Reducing Cutaneous Side-Effects of Radiation Treatment for Breast Cancer.


BackgroundRadiation therapy is an important component of treatment for breast cancer,
especially in the setting of breast conservation. Even though cancer patients who are
receiving radiation treatments follow established hygiene and skin-care protocols they still
experience differing degrees of cutaneous skin reactions and associated symptoms of dryness,
itchiness, burning sensations, and pain.1-7 For some patients the side-effects associated
with radiation therapy can become so severe serious consideration is given to discontinuing
treatments. The treatments currently used for reducing cutaneous reactions and symptoms are
very limited and often ineffective.5-7 Anti-inflammatories and steroid-based topical
pharmaceutical agents are used sparingly due in part to research findings8 and potential
harmful side-effects.7 This has left physicians and patients using a trial and error
approach in seeking an alternative treatment that will help these patients cope with (and
sometimes endure) the cutaneous radiation side-effects. Ongoing clinical experience and
discussions with present and former radiation patients reveals that skin irritation,
breakdown, pain and associated suffering are common side-effects that patients wish they did
not have to experience. The lack of effective, efficient, non-pharmacological treatments for
reducing symptoms associated with cutaneous skin reactions to radiation cancer therapy is
problematic. Study Objectives the overall aim of the study is to determine if biologically
active A. barbadensis is a therapeutic agent for reduction of cutaneous side effects women
experience as a result of undergoing radiation therapy for breast cancer.The primary aim is
to determine if there is a significant reduction or increase of cutaneous skin reactions
using A. barbadensis on the irradiated skin of the breast or chest wall in comparison to
following the standard CCI non-pharmacological treatment protocol and in comparison to using
the moist inert vehicle gel on the irradiated site.The secondary aim is to explore if there
is a reduction or increase in subjective symptoms at the irradiated site with the use of A.
barbadensis in comparison to following the standard CCI 'best care' non-pharmacological
treatment protocol and in comparison to using the moist inert vehicle gel on the irradiated
site.MethodThis study is a single blind randomized controlled trial using a three Arm
design. Analysis stratification is being conducted according to radiation technique, breast
size, smoker vs. non-smoker, nutrition, protocol adherence, and prior chemotherapy. The
control arm will treat the skin reaction as per standard CCI breast radiation protocol


Inclusion Criteria:



- adult age women receiving 4500cGy or 5000cGy for non-metastatic breast cancer.

- tumor bed boost allowed.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Skin reaction severity.

Principal Investigator

Donna L. Hoopfer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

PS-08-0006

NCT ID:

NCT00156806

Start Date:

March 2002

Completion Date:

May 2006

Related Keywords:

  • - Breast Cancer
  • aloe
  • radiation dermatitis
  • radiation therapy
  • Breast Neoplasms

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