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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how steroid therapy can improve symptoms in individuals who have recovered from oropharyngeal cancer but experience nerve problems due to past radiation treatment. The focus is on using either prednisone or methylprednisolone (a type of steroid) to alleviate issues related to lower cranial neuropathy, which affects swallowing and speech. It suits those who had oropharyngeal cancer, have been disease-free for over two years after radiation, and face ongoing nerve problems. Participants must be willing to return for assessments and complete symptom surveys in a language they understand. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in care.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that steroid treatments like prednisone and methylprednisolone are generally safe. Studies have found that even at high doses, these steroids are often well-tolerated. For instance, taking prednisone at a dose of 3 mg per kilogram of body weight usually causes only mild side effects, with few experiencing moderate to severe issues.

Methylprednisolone is also considered safe, but like many steroids, it can have side effects. Common ones include changes in appetite or mood. Discussing possible risks with a doctor is important. Both treatments have been used for many conditions, so their safety is well understood. However, since reactions can vary, monitoring how one feels is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these steroid treatments for head and neck cancer-related cranial neuropathy because they offer a potentially faster response time compared to traditional therapies. Unlike standard treatments, which might take weeks to show improvements, prednisone and methylprednisolone are designed to act quickly, potentially providing relief in just a few days. Additionally, these steroids may reduce inflammation and nerve damage more effectively, helping patients maintain a better quality of life during treatment.

What evidence suggests that steroid therapy might be an effective treatment for cranial neuropathy?

Research has shown that steroid treatments like prednisone or methylprednisolone, which participants in this trial may receive, can improve symptoms of nerve damage caused by past radiation treatments. Patients have experienced better nerve function, making swallowing easier. Prednisone and methylprednisolone are corticosteroids that reduce inflammation and swelling, easing pressure on nerves and improving their function. While more research is needed, early findings suggest these steroids might effectively manage symptoms from nerve damage due to previous cancer treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Katherine A Hutcheson, BA,MS,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04151082

Study Details | NCT04151082 | High Dose Steroid Therapy ... To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes (PROs) among head and neck cancer (HNC) survivors with ...

2. withpower.com withpower.com/trial/phase-2-cranial-nerve-diseases-9-2019-b53fb

Steroid Therapy for Head and Neck Cancer-Related ... Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy. Show more.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7747216/

Incidence and outcomes of radiation-induced late cranial ... To characterize the late cranial neuropathy among 10-year survivors of head and neck cancer treatment We retrospectively evaluated patients ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-06735

High Dose Steroid Therapy (Prednisone or ... Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.

5. go.drugbank.com go.drugbank.com/drugs/DB00959/clinical_trials?conditions=DBCOND0030102%2CDBCOND0018038&phase=1&purpose=supportive_care&status=active_not_recruiting

Methylprednisolone Active Not Recruiting Phase 1 Trials ... Methylprednisolone Active Not Recruiting Phase 1 Trials for Cranial nerve disorder / Carcinoma of the Head and Neck Supportive Care.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/011856s136lbl.pdf

SOLU-MEDROL® (methylprednisolone sodium succinate for ... The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General.

7. mayoclinic.org mayoclinic.org/drugs-supplements/methylprednisolone-injection-route/description/drg-20075216

Methylprednisolone (injection route) - Side effects & uses This medicine may increase your risk for cancer, including Kaposi's sarcoma. Tell your doctor right away if you have flat, painless spots that ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7685771/

Radiation-induced neuropathies in head and neck cancer In the scope of this review, we discuss the use of variable management and therapeutic modalities to palliate common radiation-induced neuropathies in head and ...