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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

Must not have

Palliative treatment

Partial breast irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 days after completion of radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am receiving radiation therapy to the breast or chest wall after surgery for breast cancer.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving care focused on relieving symptoms.

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I have received radiation therapy to part of my breast.

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I have inflammatory breast cancer with skin involvement.

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I do not have a history of diseases like xeroderma pigmentosum.

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I have had radiation in the same area where more is planned.

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I am receiving a short course of radiation therapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days after completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Radiation Dermatitis

Secondary study objectives

Quality of life (QoL)

Supportive measures

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181

73%

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met