What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiation therapy, hormone therapy, and targeted therapy, have a range of side effects. Chemotherapy can cause nausea, hair loss, fatigue, and increased infection risk. Radiation therapy often leads to skin irritation, fatigue, and localized pain. Hormone therapy may result in hot flashes, mood swings, and increased risk of blood clots. Targeted therapies can cause diarrhea, liver problems, and skin rashes. The caffeine-based cream being studied aims to reduce reconstructive complications and may cause skin irritation or allergic reactions.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer have included a variety of drugs and therapies targeting different aspects of the disease. While the specific trial mentioned focuses on a caffeine-based cream with anti-inflammatory and antioxidant properties, similar treatments in terms of mechanism include anti-inflammatory drugs like NSAIDs and corticosteroids, which are sometimes used to manage symptoms and side effects in cancer patients. Additionally, antioxidants are often explored in supportive care to mitigate oxidative stress in cancer therapy. However, the primary FDA-approved treatments for breast cancer typically involve chemotherapy, hormone therapy, targeted therapy, and immunotherapy, rather than topical agents.

What other types of research exist?

One promising alternative to caffeine-based cream for breast cancer patients is green tea catechins, specifically sinecatechins, which have demonstrated anti-inflammatory and antioxidant properties. Another potential option is the use of polyphenon E, a green tea extract, which has shown efficacy in treating various skin conditions and may offer benefits in managing skin complications during breast cancer treatment.

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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)

Must not have

Patient has (cT4b-d) unhealed wound in the radiation field

Planned accelerated or hypofractionated fractionation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I won't need extra radiation doses as they could affect the study's main outcome.

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I have had radiation therapy on the same side of my chest before.

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I am not pregnant, as confirmed by a urine test.

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I have skin changes or inflammation in my breast.

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I have lupus or scleroderma, which could worsen skin reactions to radiation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Standard Toxicity Scoring

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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery and radiation aim to remove or destroy cancer cells locally. Chemotherapy uses drugs to kill rapidly dividing cells throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers. Targeted therapies, such as trastuzumab, specifically attack cancer cells with certain markers, minimizing damage to normal cells. The caffeine-based cream being studied leverages caffeine's anti-inflammatory and antioxidant properties to potentially reduce complications from radiation therapy. These mechanisms are crucial as they aim to improve treatment efficacy while minimizing side effects, enhancing the overall quality of life for breast cancer patients.

Effects of botanical drugs in the treatment of cancer-related fatigue in patients with gastric cancer: A meta-analysis and prediction of potential pharmacological mechanisms.UVB and caffeine: inhibiting the DNA damage response to protect against the adverse effects of UVB.