Caffeine-based Cream for Breast Cancer

(ReDCoAT Trial)

Overseen By Naamit K Gerber, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Chemotherapy

Disqualifiers: Inflammatory carcinoma, Unhealed wound, Lupus, Scleroderma, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a caffeine-based cream to see if it can help reduce problems after breast reconstruction surgery in patients who need radiation therapy. The cream is compared to another cream to check its effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you will receive chemotherapy with radiation, but you can continue hormonal therapy or Trastuzumab.

Is Lipoderm Cream Base safe for use in humans?

In a study involving patients undergoing radiation therapy, Lipoderm Cream Base was used without any significant safety concerns reported, and 86% of patients expressed satisfaction with the ointment. ^{1 2 3 4 5}

How is the caffeine-based cream treatment for breast cancer different from other treatments?

The caffeine-based cream for breast cancer is unique because it uses caffeine anhydrous, a form of caffeine, in a topical cream base, which is different from traditional oral or intravenous cancer treatments. This approach may offer a novel way to deliver treatment directly to the affected area, potentially reducing systemic side effects. ^{6 7 8 9 10}

Research Team

Naamit Kurshan Gerber

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for breast cancer patients who've had a mastectomy with tissue expander reconstruction and need post-mastectomy radiation. They must not be pregnant, have no previous chest radiation, or concurrent chemo (except hormonal therapy or Trastuzumab). Those with inflammatory breast cancer, unhealed wounds in the radiation field, caffeine allergy, lupus, or scleroderma are excluded.

Inclusion Criteria

I will undergo chest wall radiation therapy.

I have been diagnosed with breast cancer.

I am allowed to receive additional radiation to specific areas if needed.

Exclusion Criteria

You are allergic to caffeine.

I have an unhealed wound in the area treated with radiation.

I am scheduled for a fast or intense course of radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy along with either caffeine-based cream or placebo cream

Duration of radiation therapy

Post-Radiation Treatment

Participants continue using the assigned cream for 4 weeks following radiation therapy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• Caffeine anhydrous 5% added to Lipoderm Cream Base
• Lipoderm Cream Base

Trial Overview The study tests if a caffeine-based antifibrosis cream can lower reconstructive complications from radiation therapy compared to a placebo. Participants will apply either the caffeine cream or placebo to their chest wall during their treatment period.

Participant Groups

Group I: Caffeine Based Cream Experimental Treatment 1 Intervention

caffeine based cream during and for 4 weeks following radiation

Group II: Placebo Placebo Group 1 Intervention

placebo cream during and for 4 weeks following radiation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis. [2017]

2. Greece pubmed.ncbi.nlm.nih.gov

Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Topical use of phytotherapic cream (Capilen® cream) to prevent radiodermatitis in breast cancer: a prospective historically controlled clinical study. [2014]

4. Egypt pubmed.ncbi.nlm.nih.gov

Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dihydroconiferyl Ferulate Isolated from Dendropanax morbiferus H.Lév. Suppresses Stemness of Breast Cancer Cells via Nuclear EGFR/c-Myc Signaling. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Anti-Xanthine Oxidase 5'-Hydroxyhericenes A-D from the Edible Mushroom Hericium erinaceus and Structure Revision of 3-[2,3-Dihydroxy-4-(hydroxymethyl)tetrahydrofuran-1-yl]-pyridine-4,5-diol. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Breast Cancer Activities of 8-Hydroxydaidzein by Targeting Breast Cancer Stem-Like Cells. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Disruption of the NF-κB/IL-8 Signaling Axis by Sulconazole Inhibits Human Breast Cancer Stem Cell Formation. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Trial of Essiac to ascertain its effect in women with breast cancer (TEA-BC). [2015]