What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, including radiation therapy and chemotherapy, often result in side effects such as mucositis, xerostomia (dry mouth), dysgeusia (altered taste), and fatigue. Specific to the study of Dermaprazole, a reformulated PPI cream, the focus is on managing radiation dermatitis, which typically presents with skin irritation, redness, and desquamation. Other systemic treatments like chemotherapy can cause additional side effects such as nausea, vomiting, and immunosuppression. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for head and neck cancers include a variety of systemic therapies such as chemotherapy, immunotherapy, and targeted therapies. Notable drugs include cetuximab, an anti-EGFR monoclonal antibody, which has shown significant improvements in overall survival when combined with chemotherapy. Immunotherapies like nivolumab and pembrolizumab, which target PD-1, are also approved for patients who have previously been treated with platinum-based chemotherapy. These treatments have demonstrated important clinical activity in managing metastatic or recurrent squamous cell carcinoma of the head and neck. While the study of Dermaprazole, a proton pump inhibitor cream, is novel, there is no prior FDA approval for PPI-based treatments specifically for head and neck cancers.

What other types of research exist?

Promising novel alternatives to Dermaprazole for head and neck cancer patients include targeted therapies such as selpercatinib and pralsetinib, which have shown efficacy in RET-altered thyroid cancers. Additionally, immunotherapies like nivolumab and pembrolizumab have demonstrated effectiveness in various cancers, including esophageal and gastric cancers, and may offer potential benefits for head and neck cancer patients.

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Proton Pump Inhibitor

Dermaprazole Cream for Radiation Dermatitis

Phase 2

Recruiting

Led By Mohamad A Fakhreddine, MD

Research Sponsored by Mohamad Hassan Fakhreddine

Eligibility Criteria Checklist

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

Must have

Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)

Planned to receive definitive chemoradiation of at least 66Gy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

This trial will study whether a new PPI cream is safe and effective in treating head and neck cancer patients.

Who is the study for?

This trial is for adults over 18 with head and neck cancer, excluding brain malignancies, who are set to receive at least 66Gy of chemoradiation. They should have a performance status that allows daily activities (ECOG 0-2) and no prior treatments like head and neck radiotherapy or neoadjuvant chemotherapy. Those taking proton pump inhibitors must stop with their doctor's approval.Check my eligibility

What is being tested?

The study tests Dermaprazole cream against Aquaphor in preventing radiation dermatitis during cancer treatment. It aims to see if the reformulated proton pump inhibitor cream is safe and effective for patients undergoing definitive chemoradiation therapy for head and neck cancers.See study design

What are the potential side effects?

While specific side effects of Dermaprazole aren't detailed here, similar creams may cause skin reactions such as redness, itching, or rash. Patients might also experience typical side effects from radiation like dryness or peeling skin.

Eligibility Criteria

Inclusion Criteria

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

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I have a cancer in my head or neck area, but not in my brain.

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I am scheduled for a specific cancer treatment with radiation.

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I have a confirmed diagnosis of head and neck cancer from a biopsy.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher

Side effects data

From 2020 Phase 4 trial • 66 Patients • NCT03094416

Upper respiratory tract infection

Diarrhoea

Nausea

Vomiting

Constipation

Gastroenteritis

Subcutaneous abscess

Hyperlipidaemia

Cough

Bronchitis

Urinary tract infection

Musculoskeletal pain

Dizziness

Asthma

Arthralgia

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Period: Tirosint Capsules

Run-in Period: LT4 Tablets

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DermaprazoleExperimental Treatment1 Intervention

30 HNC patients who will be using Dermaprazole twice daily for 7 weeks

Group II: AquaphorActive Control1 Intervention

15 HNC patients using Aquaphor, the current clinical standard of care

0 / 5Eligibility 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 Head and Neck Cancers (HNC) include surgery, radiation therapy, chemotherapy, and targeted therapies. Surgery physically removes the tumor, aiming for complete resection while preserving function. Radiation therapy uses high-energy rays to kill cancer cells, often employed to control local-regional disease. Chemotherapy involves cytotoxic drugs that target rapidly dividing cells, used alone or in combination with other treatments. Targeted therapies, such as cetuximab, inhibit specific molecular pathways critical for cancer cell survival and proliferation. These treatments are crucial for HNC patients as they aim to eradicate cancer while preserving essential functions like swallowing and salivation. Dermaprazole, a proton pump inhibitor cream under investigation, may offer a novel approach to managing radiation dermatitis, a common side effect of radiation therapy, potentially improving patient comfort and treatment adherence.

ACR Appropriateness Criteria: local-regional therapy for resectable oropharyngeal squamous cell carcinomas.