Could a simple cream ease radiation skin woes for breast cancer patients?
NCT ID NCT06966388
First seen Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This pilot study is testing whether breast cancer patients can apply azelaic acid cream twice daily during radiation treatment. The cream is meant to help with skin side effects from radiation. The study will enroll 33 adults with breast cancer who are about to start radiation therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azelaic acid cream
- What this could lead to
- If this works, it could point toward a simple way to reduce skin irritation during radiation for breast cancer.
- What could go wrong
- This is a very small, early-phase pilot study with only 33 participants. It only tests if patients can use the cream twice daily, not whether it actually helps skin problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age ≥ 18 years * Self-reports as Black, Asian, Hispanic/Latin, ethnically originating from the Mediterranean rim or Pacific rim, or she/he tans easily in the sun * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18) * Attestation by the patient that she/he is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period * Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy * Treatment plan includes one of the following: * Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions) * Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions) * Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions) * Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface * Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician. * Radiation will be photon-based. Note: If the patient receives a boost, photons and/or electrons may be used at the discretion of the treating physician. Exclusion Criteria: * Prior radiotherapy to any portion of the planned treatment site * Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy * Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed * Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field * Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis) * History of organ transplant or bone marrow transplant * History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation * Has used within 28 days prior to baseline: * topical retinoids to the breast * oral retinoids * systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim) * systemic corticosteroids or immunosuppressive drugs, except as part of standard chemotherapy treatment or used for an IV contrast allergy * Has used on treated breast within 2 weeks prior to baseline: * topical corticosteroids * topical antibiotics * topical medications for skin rash (eg, metronidazole, azelaic acid) * Radiation therapy will be proton therapy or carbon therapy * External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
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