Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156806
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2005-09-07
Brief Title:
Investigating the Therapeutic Effectiveness of Aloe Barbadensis in Reducing Cutaneous Side-Effects of Radiation Treatment for Breast Cancer
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
Investigating the Therapeutic Effectiveness of Aloe Barbadensis in Reducing Cutaneous Side-Effects of Radiation Treatment for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 pain1-7 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 ineffective5-7 Anti-inflammatories and steroid-based topical pharmaceutical agents are used sparingly due in part to research findings8 and potential harmful side-effects7 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 cancerThe 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 siteThe 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 siteMethodThis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None