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Steroids & Bacterial Decolonization for Radiation Skin Damage
Phase 2
Waitlist Available
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial aims to see if a combination of bacterial decolonization and steroid therapy can reduce skin irritation in cancer patients receiving radiation therapy and improve their quality of life.
Who is the study for?
This trial is for adults over 18 with breast or head and neck cancer who are scheduled for radiotherapy. It's not open to those with skin conditions like eczema, psoriasis, non-healing wounds in the treatment area, or allergies to the treatments being tested.Check my eligibility
What is being tested?
The study is testing if cleaning the skin and nose of bacteria (decolonization), using a steroid cream (Mometasone furoate), or both can prevent severe radiation dermatitis in patients undergoing radiotherapy for cancer.See study design
What are the potential side effects?
Possible side effects include skin irritation from bacterial decolonization methods and reactions to Mometasone such as burning, itching, dryness at the application site. More serious but less common effects might be changes in skin color or thinning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade >2 RD
Secondary outcome measures
Quality of life Score Change
Other outcome measures
Changes in the cutaneous microbiome and transcriptome
Trial Design
3Treatment groups
Experimental Treatment
Group I: Topical corticosteroidExperimental Treatment1 Intervention
Mometasone furoate 0.1% cream
Group II: CombinationExperimental Treatment1 Intervention
Validated decolonization regimen and mometasone furoate 0.1% cream
Group III: Bacterial decolonizationExperimental Treatment1 Intervention
Validated decolonization regimen
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,196 Total Patients Enrolled
Lindsay PattisonStudy DirectorMontefiore Medical Center
Yana KostStudy DirectorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a skin condition in the area where the treatment will be applied, such as eczema, psoriasis, or non-healing wounds, or you are allergic to the treatment.You are 18 years old or older.You have breast or head and neck cancer and are planning to receive a specific type of radiation treatment with the goal of curing the cancer.You have had radiation therapy to the area being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Topical corticosteroid
- Group 2: Combination
- Group 3: Bacterial decolonization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given approval to Combination?
"There is evidence to suggest the safety of Combination, resulting in it receiving a score of 2. However, as this research project has only reached Phase 2, there are no data confirming its efficacy yet."
Answered by AI
Is there still capacity for participants in this experiment?
"Presently, clinicaltrials.gov indicates that this medical experiment is not taking on additional patients. Initially posted in March of 2023 and edited in January of the same year, no further recruiting will be done at this time; however, there are 213 other trials actively seeking participants right now."
Answered by AI
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