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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a caffeine-based cream can reduce complications in breast cancer patients who have undergone a mastectomy and require radiation therapy. The treatment involves applying a cream with caffeine anhydrous 5% added to Lipoderm Cream Base and comparing it to a placebo cream. It targets patients who have had breast cancer surgery with tissue expanders and are undergoing radiation. Participants must not have skin changes or inflammatory breast cancer and should not receive certain other treatments during the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a 5% caffeine cream is generally well-tolerated by patients. Early results suggest mild and manageable side effects, particularly for those undergoing breast cancer treatment. The cream aims to reduce skin problems during radiation therapy.

While detailed safety information is still being gathered, the cream has already passed some initial safety tests. Treatments reaching this stage have usually demonstrated a good safety record in earlier studies, with typically mild and manageable side effects.

For those considering joining a trial, this information may provide confidence in the treatment's safety. It is important to consult a healthcare provider to determine if this trial is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard breast cancer treatments that often involve chemotherapy, surgery, or radiation, this caffeine-based cream introduces a novel approach by using caffeine anhydrous as an active ingredient. Researchers are excited because caffeine has properties that can potentially enhance the effects of radiation therapy, providing a boost to cancer-fighting efforts directly through the skin. This topical application could offer a more localized treatment with fewer systemic side effects, making it a promising addition to current breast cancer care options.

What evidence suggests that this caffeine-based cream might be an effective treatment for reducing reconstructive complications in breast cancer patients?

This trial will compare a caffeine-based cream with a placebo cream for breast cancer patients. Research has shown that caffeine can reduce inflammation, potentially aiding in healing. Although limited data exists on using caffeine in a cream for breast cancer patients, early results suggest it could alleviate issues after reconstructive surgery. Other studies have found that caffeine can improve skin healing and reduce inflammation. This is important because inflammation can complicate recovery. Overall, caffeine might soothe the skin and support healing after surgery and radiation. ^{1 2 3 4 5}

Who Is on the Research Team?

Naamit Kurshan Gerber

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03768492

NCT03768492 | Study of the Safety and Efficacy ... The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander ...

2. withpower.com withpower.com/trial/phase-3-breast-neoplasms-11-2019-38667

Caffeine-based Cream for Breast Cancer (ReDCoAT 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03768492?tab=history&a=4

Record History | ver. 4: 2021-02-01 | NCT03768492 The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-08948

Topical Caffeine Compound for the Reduction of ... This phase II trial studies the side effects of topical caffeine compound and to see how well it works in reducing the complications in patients with stage 0- ...

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/1091/radiation-dermatitis-phase-1/

Perlmutter Cancer Center - Clinical Trials The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of complications in patients with tissue expander based ...