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Topical Agents for Radiation Dermatitis in Breast Cancer
Phase 1
Recruiting
Led By Scott M Glaser
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing external beam radiation therapy (EBRT) to the breast or chest wall following surgical resection (lumpectomy or mastectomy) for ductal carcinoma in situ (DCIS) or invasive breast cancer using either conventional fractionation or hypofractionation
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days after completion of radiation therapy
Awards & highlights
Study Summary
This trial will compare the two agents to see which is more effective in treating radiation dermatitis.
Who is the study for?
This trial is for adults over 18 with breast cancer who've had surgery and are now getting standard radiation therapy. It's not for those with inflammatory breast cancer, skin involvement, plans to use other topical products during the study, or a history of diseases that make them extra sensitive to radiation.Check my eligibility
What is being tested?
The trial compares Aquaphor (a petrolatum-based ointment) and Miaderm (a water-based cream with calendula, hyaluronate, and aloe vera) in treating acute radiation dermatitis in patients undergoing radiation therapy after breast cancer surgery.See study design
What are the potential side effects?
Potential side effects may include skin reactions like itching or swelling where the creams are applied. Since these are topical agents, systemic side effects are unlikely but could include allergic reactions to ingredients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving radiation therapy to the breast or chest wall after surgery for breast cancer.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 120 days after completion of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 days after completion of radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Radiation Dermatitis
Secondary outcome measures
Quality of life (QoL)
Supportive measures
Side effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (Miaderm)Experimental Treatment3 Interventions
Beginning on day 1 of radiation therapy, patients apply Miaderm BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Group II: Arm I (Aquaphor)Experimental Treatment3 Interventions
Beginning on day 1 of radiation therapy, patients apply Aquaphor BID, but not within the four hours before EBRT, to the irradiated field until 2 weeks following completion of EBRT.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,654 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,460 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
Scott M GlaserPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving care focused on relieving symptoms.I have received radiation therapy to part of my breast.I am receiving radiation therapy to the breast or chest wall after surgery for breast cancer.I am older than 18 years.I have inflammatory breast cancer with skin involvement.I plan to use a skin product other than Aquaphor or Miaderm.I do not have a history of diseases like xeroderma pigmentosum.I have had radiation in the same area where more is planned.I am receiving a short course of radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (Aquaphor)
- Group 2: Arm II (Miaderm)
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.
Is Quality-of-Life Assessment a secure procedure for patients?
"Our collective at Power has assigned Quality-of-Life Assessment a score of 1, as this is an initial stage clinical trial with limited data that verifies safety and efficacy."
Answered by AI
How many contributors are there to this research project?
"Affirmative. Clinicaltrials.gov contains evidence that this trial is currently recruiting participants, having been first posted on June 21st 2022 and last updated on June 30th 2022. 200 individuals are required to join the study from a single medical facility."
Answered by AI
Is there opportunity to enroll in this research endeavor?
"Clinicaltrials.gov displays evidence that this research study is recruiting patients, having been made public on June 21st 2022 and edited most recently on the 30th of June 2022."
Answered by AI
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