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Corticosteroid

Steroid Therapy for Head and Neck Cancer-Related Cranial Neuropathy

Phase 1 & 2

Recruiting

Led By Katherine A Hutcheson

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Disease free adult survivors of oropharyngeal cancer

>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)

Must not have

Untreated or treatment refractory obstructive pharyngoesophageal stricture

Known gastrointestinal ulcer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of steroid therapy in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors.

Who is the study for?

This trial is for adult survivors of oropharyngeal cancer who are disease-free, treated with radiotherapy at least 2 years ago, and suffering from late radiation-associated lower cranial neuropathy. Participants must be able to complete a symptom survey in one of several languages and return for post-therapy assessment. Those with uncontrolled diabetes, hypertension, psychosis, gastrointestinal ulcers, bipolar disorder or pregnant women cannot join.

What is being tested?

The trial is testing high doses of steroid therapy (either Prednisone or Methylprednisolone) to see if they can improve symptoms caused by nerve damage after radiation treatment in throat cancer survivors. It's designed to find the best dose that reduces these symptoms effectively.

What are the potential side effects?

Possible side effects from the steroid therapy may include increased blood sugar levels which could affect diabetics, mood swings or psychological effects like mania (especially important for those with a history of psychosis), higher blood pressure, and potential stomach issues such as ulcers.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult who has recovered from throat cancer.

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I finished my cancer treatment over 2 years ago and have been monitoring since.

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I am an adult who has recovered from head and neck cancer without any signs of the disease.

Exclusion Criteria

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

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I have a throat blockage that hasn't been treated or didn't respond to treatment.

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I have a diagnosed stomach or intestinal ulcer.

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My diabetes is not under control.

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My blood pressure is not higher than 160/90.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

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

Secondary study objectives

Changes in maximum isometric lingual strength (MILS) and lingual range of motion (LROM)

Changes in patient reported outcomes (PRO) on MD Anderson Dysphagia Inventory (MDADI), Performance Status Scale for Head and Neck (PSS-HN), or EuroQOL (EQ-5D)

Improvement in dynamic imaging grade of swallowing toxicity (DIGEST) scores

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (steroid therapy)Experimental Treatment4 Interventions

Patients receive prednisone PO (or by feeding tube) QD on days 1-5 and then taper off over 2 weeks or methylprednisolone IV over 1 hour on days 1-5 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Methylprednisolone

2015

Completed Phase 4

~2280