What side effects are associated with this type of intervention?

Common treatments for cardioprotection, such as Dexrazoxane, may have side effects including nausea, vomiting, diarrhea, and fatigue. Other cardioprotective agents, like beta-blockers and ACE inhibitors, can cause dizziness, hypotension, and bradycardia. It is important to monitor for these side effects and discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

Dexrazoxane is an FDA-approved cardioprotective agent used to prevent Doxorubicin-induced cardiotoxicity in cancer patients. Other cardioprotective agents include beta-blockers and ACE inhibitors, which are commonly used to manage heart failure and reduce the risk of cardiotoxicity in various clinical settings. Additionally, drugs like carvedilol and enalapril have been studied for their cardioprotective effects in patients undergoing chemotherapy. These treatments aim to mitigate the adverse cardiac effects associated with certain cancer therapies, ensuring better cardiovascular outcomes for patients.

What other types of research exist?

Currently, there are no specific novel alternatives to Dexrazoxane mentioned in the provided context. However, ongoing research in cardioprotective agents, such as the use of angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs), may offer potential benefits. These agents have shown promise in various cardiovascular conditions and could be considered as part of a cardioprotective strategy. Patients should discuss with their healthcare provider to explore the most current and suitable options available in 2024.

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Anti-tumor antibiotic

Dexrazoxane for Preventing Heart Failure (PHOENIX1 Trial)

Phase 1

Recruiting

Led By Hui-Ming Chang, MD,MPH

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

No current illness

Age 18-65

Must not have

History of renal disease

History of cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after administration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Dexrazoxane can protect the heart from damage caused by the cancer drug Doxorubicin. Dexrazoxane is a heart-protecting agent approved to reduce heart damage from Doxorubicin. Volunteers will receive one dose of Dexrazoxane. The study will measure how well the drug breaks down a specific protein in the blood that might be linked to heart damage.

Who is the study for?

This trial is for healthy women aged 18-65 who are not pregnant, not breastfeeding, and have no current illnesses. It's not open to those with a history of kidney or heart disease, or who are currently ill.

What is being tested?

The study is testing if Dexrazoxane given early can prevent heart damage caused by Doxorubicin, a drug used in cancer treatment. The focus is on preventing heart failure in patients receiving Doxorubicin.

What are the potential side effects?

Dexrazoxane may cause side effects such as nausea, vomiting, diarrhea, dizziness and low blood cell counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any current illnesses.

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I am between 18 and 65 years old.

Exclusion Criteria

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

Select...

I have a history of kidney disease.

Select...

I have a history of heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after administration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Degradation of Topoisomerase 2 b

Side effects data

From 2022 Phase 2 trial • 73 Patients • NCT02584309

100%

Alopecia

100%

Anemia

90%

Lymphocytes decreased

80%

Nausea

70%

Hypocalcemia

70%

Fatigue

60%

Hypokalemia

60%

Constipation

50%

Creatinine increased

50%

Alkaline phosphatase increased

50%

Anxiety

40%

Headache

40%

White blood cell decreased

30%

Hypernatremia

30%

Febrile neutropenia

30%

Diarrhea

30%

Mucositis oral

30%

Neutrophil count decreased

30%

Platelet count decreased

30%

Hyponatremia

30%

Bone pain

20%

Hypertriglyceridemia

20%

Hypoalbuminemia

20%

Fever

20%

Peripheral sensory neuropathy

20%

Hyperglycemia

20%

Back pain

20%

Pain in extremity

20%

Flushing

20%

Thromboembolic event

10%

Fracture

10%

Nasal congestion

10%

Abdominal pain

10%

INR increased

10%

Alanine aminotransferase increased

10%

Myalgia

10%

Sinus pain

10%

Edema limbs

10%

Hypermagnesemia

10%

Hematuria

10%

Sinus tachycardia

10%

Stomach pain

10%

Flu like symptoms

10%

Vomiting

10%

Sinus bradycardia

10%

Respiratory failure

10%

Oral dysethesia

10%

Lung infection

10%

Pharyngitis

10%

Rash pustular

10%

Wound complication

10%

Anorexia

10%

Hypercalcemia

10%

Chest wall pain

10%

Myositis

10%

Spasticity

10%

Depression

10%

Proteinuria

10%

Dyspnea

10%

Hoarseness

10%

Pneumothorax

10%

Pruritus

10%

Rash acneiform

10%

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)

Arm 1: Doxorubicin and Upfront Dexrazoxane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Dexrazoxane 500mg/m2Experimental Treatment1 Intervention

one dose of 500 mg/m2

Group II: Dexrazoxane 400mg/m2Experimental Treatment1 Intervention

one dose of 400mg/m2 dexrazoxane

Group III: Dexrazoxane 300mg/m2Experimental Treatment1 Intervention

one dose of 300mg/m2 dexrazoxane

Group IV: Dexrazoxane 200mg/m2Experimental Treatment1 Intervention

one dose of 200mg/m2 dexrazoxane

Group V: Dexrazoxane 100mg/m2Experimental Treatment1 Intervention

one dose of 100mg/m2 dexrazoxane

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexrazoxane

2016

Completed Phase 2

~80

0 / 4Eligibility 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 cardioprotection, such as Dexrazoxane, work by chelating iron to reduce free radical formation and oxidative damage to cardiac cells. This is particularly important for healthy subjects undergoing treatments like chemotherapy, as it helps prevent cardiotoxicity and preserves heart function, thereby reducing the risk of heart failure and improving overall treatment outcomes.

[Perioperative cardioprotection - From bench to bedside : Current experimental evidence and possible reasons for the limited translation into the clinical setting].Remote Ischemic Conditioning and Renal Protection.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.