← Back to Search

Corticosteroid

Steroid Therapy for Head and Neck Cancer-Related Cranial Neuropathy

Phase 1 & 2
Waitlist Available
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
Treated with radiotherapy >= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)
Disease free adult survivors of oropharyngeal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I finished my radiotherapy at least 2 years ago and have been monitored since.
Select...
I am an adult who has recovered from throat cancer.
Select...
I have nerve damage in my lower skull not caused by cancer.
Select...
I can come back for check-ups after steroid treatment.
Select...
I can complete a symptom survey in one of the listed languages.
Select...
I finished my cancer treatment over 2 years ago and have been monitoring since.
Select...
I am an adult who has recovered from head and neck cancer without any signs of the disease.
Select...
I have nerve damage in my lower skull from past radiation, not caused by cancer.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean
Maximum tolerated dose
Secondary outcome measures
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

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
~2370
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,631 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,434 Total Patients Enrolled
Katherine A HutchesonPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
154 Total Patients Enrolled

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04151082 — Phase 1 & 2
Cranial Nerve Dysfunction Research Study Groups: Supportive care (steroid therapy)
Cranial Nerve Dysfunction Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT04151082 — Phase 1 & 2
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04151082 — Phase 1 & 2

Frequently Asked Questions

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

What is the total capacity of this trial regarding participants?

"That is accurate. According to clinicaltrials.gov, this trial was initially published on October 31st 2019 and revised most recently on November 10th 2022 with the aim of recruiting 25 participants from a single site."

Answered by AI

Is enrollment in this trial ongoing at the present moment?

"The research project is recruiting according to clinicaltrials.gov, which has recorded its posting on October 31st 2019 and most recent update as November 10th 2022."

Answered by AI

Are there any past inquiries into Methylprednisolone?

"At the moment, 403 studies associated with Methylprednisolone are being conducted. Of these trials, 113 have reached Phase 3 status. Most of these clinical research projects take place in Duarte California; however there is a total of 17147 sites across the globe running related experiments."

Answered by AI

In what specific medical scenarios is Methylprednisolone regularly employed?

"Methylprednisolone can be prescribed to patients suffering from scalp structure issues, thyroiditis and ulcerative colitis."

Answered by AI

What is the desired outcome of this experiment?

"This clinical trial is due to last for 3 weeks and will monitor the Change in MD Anderson Symptom Inventory - Head and Neck (MDASI-HN) top 5 mean. Secondary objectives include 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). Specifically, this entails assessment of diet, eating, speech subscales of PSS-HN using an ordinal scale from 0 to 100; MDADI scores with a continuous scale from 20 to 100"

Answered by AI
~1 spots leftby Jul 2024