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Caffeine-based Cream for Breast Cancer (ReDCoAT Trial)

Phase 2

Waitlist Available

Led By Naamit Kurshan Gerber

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient will receive irradiation of the chest wall

Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

ReDCoAT Trial Summary

This trial will test whether a caffeine-based cream can help reduce the rates of complications for patients undergoing radiation therapy after a mastectomy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include skin reactions related to the application of the cream such as redness, itching, or rash. Since it's topical and contains caffeine, there might also be local irritation or allergic responses in those sensitive to ingredients.

ReDCoAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will undergo chest wall radiation therapy.

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I have been diagnosed with breast cancer.

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I had a mastectomy with temporary expanders and need radiation, but don't have inflammatory breast cancer.

ReDCoAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Standard Toxicity Scoring

ReDCoAT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Caffeine Based CreamExperimental Treatment1 Intervention

caffeine based cream during and for 4 weeks following radiation

Group II: PlaceboPlacebo Group1 Intervention

placebo cream during and for 4 weeks following radiation

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,666 Total Patients Enrolled

38 Trials studying Breast Cancer

7,267 Patients Enrolled for Breast Cancer

Naamit Kurshan GerberPrincipal InvestigatorNYU Langone Medical Center

Media Library

Caffeine anhydrous 5% added to Lipoderm Cream Base (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03768492 — Phase 2

Breast Cancer Research Study Groups: Caffeine Based Cream, Placebo

Breast Cancer Clinical Trial 2023: Caffeine anhydrous 5% added to Lipoderm Cream Base Highlights & Side Effects. Trial Name: NCT03768492 — Phase 2

Caffeine anhydrous 5% added to Lipoderm Cream Base (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03768492 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many guinea pigs are part of this investigation?

"That is correct, according to the clinicaltrials.gov website this study is still looking for patients. This particular trial was first posted on December 13th 2019 and updated February 7th of this year. They are seeking 60 individuals total from 1 location."

Answered by AI

What is the typical purpose for Caffeine anhydrous 5% added to Lipoderm Cream Base?

"Caffeine anhydrous 5% added to Lipoderm Cream Base can not only help with respiratory depression, but also pain related conditions like menstrual pain and myalgia."

Answered by AI

Can people sign up for this experiment currently?

"Yes, this trial is actively seeking patients. According to the listing on clinicaltrials.gov, the recruitment for this study opened on December 13th, 2019 and was last updated on February 7th, 2022."

Answered by AI

Is it safe to use caffeine anhydrous 5% in lipoderm cream base?

"Caffeine anhydrous 5% added to Lipoderm Cream Base received a score of 2. This is based on the fact that this is a Phase 2 trial, so while there is data supporting safety, there is none yet for efficacy."

Answered by AI

Does Caffeine anhydrous 5% have any benefits when used topically in Lipoderm Cream Base?

"As of now, there are 13 different clinical trials dedicated to research surrounding Caffeine anhydrous 5% added to Lipoderm Cream Base.. Out of these 13 trials, 2 have progressed to Phase 3. Although the majority of Caffeine anhydrous 5% added to Lipoderm Cream Base. trials are based in Chongqing, Chongqing, there are a total of 120 locations running similar studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

2019. "Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03768492.

All > Fibrosis