Steroid Therapy for Head and Neck Cancer-Related Cranial Neuropathy

Overseen By Katherine A Hutcheson

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Steroids

Disqualifiers: Diabetes, Hypertension, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is steroid therapy generally safe for humans?

Steroid therapy, including drugs like methylprednisolone, has been studied for various conditions and is generally considered safe for humans. Common side effects observed in studies include facial flushing, headache, and facial swelling, but no severe safety concerns were reported. ^{1 2 3 4 5}

How does the drug Methylprednisolone, Prednisone differ from other treatments for head and neck cancer-related cranial neuropathy?

This drug is unique because it involves the use of steroids, which are known for their anti-inflammatory properties, and may help reduce symptoms by decreasing inflammation around nerves. While there are no standard treatments specifically for head and neck cancer-related cranial neuropathy, steroids like Methylprednisolone and Prednisone have shown effectiveness in other neuropathic and inflammatory conditions, suggesting potential benefits for this condition. ^{1 2 4 6 7}

Research Team

Katherine A Hutcheson, BA,MS,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I finished my radiotherapy at least 2 years ago and have been monitored since.

I am an adult who has recovered from throat cancer.

I have nerve damage in my lower skull not caused by cancer.

Exclusion Criteria

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

You have a history of experiencing severe mental health issues like hallucinations or delusions.

I have a diagnosed stomach or intestinal ulcer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive prednisone orally or by feeding tube once daily on days 1-5 and then taper off over 2 weeks or methylprednisolone intravenously over 1 hour on days 1-5

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of patient-reported outcomes and imaging studies

Up to 3 years

Treatment Details

Interventions

• Methylprednisolone
• Prednisone

Trial Overview 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.

Participant Groups

Group I: Supportive care (steroid therapy) Experimental Treatment 4 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.

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Approved in European Union as Depo-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Approved in Canada as Solu-Medrol for:

• Allergic reactions
• Blood disorders
• Cancer
• Eye diseases
• Immune system disorders
• Inflammatory diseases
• Respiratory diseases
• Skin diseases

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 56 chemotherapy-naive patients, both 250 mg and 500 mg doses of methylprednisolone succinate provided similar antiemetic effects, with 79% and 69% of patients experiencing complete or major protection from vomiting during two treatment courses, respectively.

The study found no significant differences in side effects or patient preference between the two doses, with common side effects including facial flushing (45%), headache (22%), and facial edema (18%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized crossover study to compare the antiemetic efficacy of 250 mg with 500 mg methylprednisolone succinate (Solu-Medrol) as a single intravenous dose in patients treated with noncisplatin chemotherapy. Pieters, RC., Vermorken, JB., Gall, HE., et al.[2018]

In a study involving 310 patients undergoing surgery for cerebellopontine angle tumors, corticosteroids administered during and after surgery did not improve facial function outcomes, as measured by the House and Brackmann grading scale, at 1, 8, and 30 days post-operation.

The study included both small and large tumors and was conducted as a multicenter, randomized, double-blind trial, indicating a robust design; however, the use of corticosteroids did not show any significant benefit in preventing facial palsy after tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of corticosteroids on facial function after cerebellopontine angle tumor removal: a double-blind study versus placebo. Bozorg Grayeli, A., Ferrary, E., Tubach, F., et al.[2015]

Methylprednisolone (MP) did not significantly improve nerve healing in facial paralysis caused by nerve section or herpes simplex virus (HSV) infection, indicating limited efficacy in these models.

However, MP treatment showed a reduction in edema and less axonal and myelin degeneration in cases of facial paralysis due to nerve compression, suggesting it may have some beneficial effects in that specific injury type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of methylprednisolone on facial nerve paralysis with different etiologies. Yildirim, MA., Karlidag, T., Akpolat, N., et al.[2018]

In a study of 29 patients with vestibular neuritis, treatment with methylprednisolone for 2 weeks did not show significant benefits over a control group receiving vestibular exercises and Ginkgo biloba, as both groups improved similarly.

Both groups demonstrated improvements in vestibular function tests and dizziness scores over 1 and 6 months, indicating that vestibular exercises and Ginkgo biloba may be effective treatments on their own, without the need for steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of steroid therapy based on symptomatic and functional improvement in patients with vestibular neuritis: a prospective randomized controlled trial. Yoo, MH., Yang, CJ., Kim, SA., et al.[2018]

Corticosteroid treatment showed significant hearing improvement in 2 out of 6 patients with auditory neuropathy, with notable increases in speech discrimination scores after one month of therapy.

The results suggest that immunological factors may contribute to auditory neuropathy, indicating that corticosteroids could be a promising treatment option for some patients, although not all responded positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic trial with corticosteroid for auditory neuropathy]. Xing, G., Liu, Z., Wang, D., et al.[2013]

Methylprednisolone, starting at 100 mg per day and tapering to 10 mg over 3 weeks, is an effective treatment for vestibular neuritis, suggesting its role in reducing inflammation and aiding recovery.

In contrast, valacyclovir (Valtrex) was found to be ineffective for treating vestibular neuritis, indicating that antiviral therapy may not be beneficial for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid is effective for vestibular neuritis, valacyclovir is not. [2004]

An 8-year-old boy with Charcot-Marie-Tooth disease type 1 experienced episodes of acute hearing loss due to auditory neuropathy, which were successfully treated with prednisolone, highlighting the potential efficacy of steroids in managing hearing loss associated with CMT.

This case is significant as it is the first report of steroid-responsive sensorineural hearing loss in CMT, suggesting that glucocorticoids may play a role in treating similar auditory issues in patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid-dependent sensorineural hearing loss in a patient with Charcot-Marie-Tooth disease showing auditory neuropathy. Maeda, Y., Kataoka, Y., Sugaya, A., et al.[2015]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A double-blind randomized crossover study to compare the antiemetic efficacy of 250 mg with 500 mg methylprednisolone succinate (Solu-Medrol) as a single intravenous dose in patients treated with noncisplatin chemotherapy. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of corticosteroids on facial function after cerebellopontine angle tumor removal: a double-blind study versus placebo. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of methylprednisolone on facial nerve paralysis with different etiologies. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of steroid therapy based on symptomatic and functional improvement in patients with vestibular neuritis: a prospective randomized controlled trial. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Therapeutic trial with corticosteroid for auditory neuropathy]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Steroid is effective for vestibular neuritis, valacyclovir is not. [2004]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Steroid-dependent sensorineural hearing loss in a patient with Charcot-Marie-Tooth disease showing auditory neuropathy. [2015]