Alkagin Paste in the Prevention of Radiation Dermatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01408407|
Recruitment Status : Terminated
First Posted : August 3, 2011
Last Update Posted : May 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anus Neoplasms Rectal Neoplasms Urogenital Neoplasms||Other: Aveeno cream Other: Alkagin paste||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||May 2014|
Active Comparator: Arm A: standard of care
Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatment
Other: Aveeno cream
Apply cream on irradiated area twice a day
Experimental: Arm B: standard of care plus Alkagin paste
Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment.
Other: Aveeno cream
Apply cream on irradiated area twice a dayOther: Alkagin paste
Apply Alkagin paste three times a day.
- Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ]The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of Alkagin Paste compared to patients treated with institutional standard skin care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408407
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Te Vuong, MD||Jewish General Hospital|