Coffee-Inspired cream may protect breast cancer patients from radiation damage
NCT ID NCT03768492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a cream made with caffeine can help prevent skin hardening and other complications in breast cancer patients who need radiation after mastectomy with tissue expander reconstruction. About 60 participants will use either the caffeine cream or a placebo cream during radiation therapy. The goal is to see if the cream is safe and reduces side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Dec 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: * Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted) * Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation. * Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed. Exclusion Criteria: * Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d) * unhealed wound in the radiation field * Patient has allergy to Caffeine * Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development * Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab) * Planned accelerated or hypofractionated fractionation. * Previous radiation to the ipsilateral breast or chest wall or thoracic region. * Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint. * All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
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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.
Contacts and locations
Locations
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New York University Medical Center
New York, New York, 10016, United States
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