Clinical Trials Logo

Clinical Trial Summary

This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance. SECONDARY OBJECTIVES: I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care. EXPLORATORY OBJECTIVES: I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance. III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the fist dose of radiation therapy until dermatitis has returned to grade =< 1. ARM II: Patients receive standard of care including calendula and/or aquaphor applied 2-6 times daily plus hydrogel or silver silvadene or topical corticosteroids applied twice daily starting from the fist dose of radiation therapy until dermatitis has returned to grade =< 1. After completion of study, patients are followed up at 6 days and 3 weeks post-RT. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05073172
Study type Interventional
Source OHSU Knight Cancer Institute
Status Not yet recruiting
Phase N/A
Start date November 15, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04852926 - Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01422408 - Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy Phase 2
Terminated NCT02810873 - Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer N/A
Terminated NCT00770354 - Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer Phase 2
Withdrawn NCT03185871 - Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses Phase 2
Active, not recruiting NCT02983279 - Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Recruiting NCT03408353 - Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
Completed NCT01641068 - Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms N/A
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Recruiting NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A
Recruiting NCT02876107 - Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer Phase 2
Completed NCT01896778 - Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer N/A
Not yet recruiting NCT04996316 - MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
Not yet recruiting NCT05005936 - Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
Not yet recruiting NCT05041751 - Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome N/A
Recruiting NCT04054752 - Vaccine Response With NT-I7 Phase 1