Pre-Treatment Physical Therapy for Acoustic Neuroma

(VS PREHAB Trial)

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Prior VS treatment, Secondary vestibular diagnoses, Others

Compensation: Varies

Number of Visits: 1

Duration: Varies based on treatment type

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether physical therapy before treatment can benefit people with Vestibular Schwannomas (VS), a non-cancerous tumor affecting balance. Researchers aim to determine if exercises performed before surgery (microsurgical resection of VS) or radiosurgery (stereotactic radiosurgery) can improve balance scores. The trial includes different groups: some will receive pre-treatment exercises, while others will not. Suitable participants are those newly diagnosed with VS, with a tumor size of 2.5 cm or less, and planning to undergo surgery or radiosurgery. As an unphased trial, this study provides a unique opportunity to understand how pre-treatment exercises might enhance recovery and balance.

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 study team or your doctor.

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

Research shows that vestibular rehabilitation, a type of physical therapy for balance and dizziness, is generally safe for people with vestibular schwannoma, a non-cancerous tumor on the nerves related to balance and hearing. Strong evidence indicates that it can reduce symptoms and improve stability without significant risks.

For microsurgical resection, studies indicate that older patients do not experience more complications than younger ones. Many patients achieve good functional outcomes after surgery, although some may encounter issues like facial nerve problems.

Stereotactic radiosurgery, involving one or a few sessions of focused radiation treatment, is also considered safe for most people with vestibular schwannoma. With proper planning, it effectively controls tumor growth, and side effects are rare with careful monitoring.

In conclusion, research has found these treatments to be generally well-tolerated for those with vestibular schwannoma, with good safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of pre-treatment physical therapy, or "PREHAB," on patients undergoing surgery for acoustic neuroma, a type of tumor. While the standard care options usually involve just surgery, this study looks at whether starting physical therapy exercises before the procedure can help improve recovery. The PREHAB approach is unique as it aims to strengthen patients ahead of time, potentially leading to better surgical outcomes and faster post-surgery recovery. By investigating these new techniques, researchers hope to find ways to enhance patient resilience and overall treatment effectiveness for acoustic neuroma.

What evidence suggests that this trial's treatments could be effective for Vestibular Schwannomas?

Research shows that exercises designed to improve balance can benefit people with vestibular issues. Some studies indicate that these exercises can enhance balance and reduce dizziness after treatment for vestibular schwannoma, a type of non-cancerous tumor. In this trial, participants in certain arms will receive PREHAB exercises before undergoing either microsurgical resection or stereotactic radiosurgery. However, other research suggests that results can vary, with some patients experiencing different outcomes. Despite this, strong evidence supports that these exercises can enhance stability and overall function. While not all studies agree, many suggest that physical therapy before treatment could aid in balance and recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Harris, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults diagnosed with Vestibular Schwannoma (VS) of size ≤2.5 cm, confirmed by MRI, who will undergo surgery or radiosurgery. Participants must be in good health as determined by normal lab values and have an ECOG Performance Status <2. Pregnant women or those not using effective contraception are excluded.

Inclusion Criteria

My doctor confirmed I have a Vestibular Schwannoma with an MRI.

Be willing to adhere to outlined study protocol criteria and complete self-reported questionnaires (translations may be made available if the patient's primary language is not English)

For females of reproductive potential: must have a negative urine or serum pregnancy test 7 prior to enrollment and agreement to use of highly effective contraception method during study participation and for an additional 24 weeks after the completion of stereotactic radiosurgery

Exclusion Criteria

I have had treatment for my VS, including surgery or radiotherapy.

I am expected to receive radiation therapy that is not stereotactic.

Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of study related treatment and additional 24 weeks following stereotactic radiosurgery administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Rehabilitation

Participants undergo PREHAB exercises including balance, gaze stabilization, and habituation exercises prior to surgery or radiosurgery

3 weeks

1 visit per week (in-person)

Treatment

Participants receive either microsurgical resection or stereotactic radiosurgery for vestibular schwannomas

Varies based on treatment type

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint measured at 12 months post-treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Microsurgical resection of VS
• PREHAB
• Stereotactic radiosurgery

Trial Overview The trial is testing the effectiveness of pre-treatment vestibular physical therapy (PREHAB) on balance for patients with VS undergoing microsurgical resection or stereotactic radiosurgery compared to no PREHAB.

How Is the Trial Designed?

Group I: Intervention: PREHAB and Surgery Active Control 2 Interventions

PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.

Group II: Intervention: PREHAB and SRS Active Control 2 Interventions

PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.

Group III: Control: Surgery (No PREHAB) Placebo Group 1 Intervention

Subjects will undergo microsurgical resection of VS.

Group IV: Control: SRS (No PREHAB) Placebo Group 1 Intervention

Subjects will undergo stereotactic radiosurgery.

Microsurgical resection of VS is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Microsurgical resection of Vestibular Schwannoma for:

• Symptomatic Vestibular Schwannoma
• Large Vestibular Schwannomas causing brainstem compression or hydrocephalus

Approved in United States as Microsurgical resection of Vestibular Schwannoma for:

• Symptomatic Vestibular Schwannoma
• Large Vestibular Schwannomas causing brainstem compression or hydrocephalus

Approved in Canada as Microsurgical resection of Vestibular Schwannoma for:

• Symptomatic Vestibular Schwannoma
• Large Vestibular Schwannomas causing brainstem compression or hydrocephalus

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study of 17 patients with vestibular schwannomas treated with either stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT), no adverse reactions or complications were reported, indicating a high safety profile for these radiation treatments.

Within 3 months post-treatment, three tumors showed shrinkage and improvement in neurological functions, suggesting that radiation therapy can effectively reduce tumor size and alleviate symptoms, even in cases of large tumors causing brain stem compression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery and hypofractionated stereotactic radiotherapy for management of vestibular schwannomas: initial experience with 17 cases. Polovnikov, ES., Anikeeva, OY., Filatov, PV., et al.[2018]

Stereotactic radiosurgery is an effective treatment for vestibular schwannoma, offering excellent tumor control rates while minimizing the risks associated with traditional surgery.

Using the Cyberknife system for staged stereotactic radiotherapy has resulted in a 77% hearing preservation rate at 2 years, making it a promising option for patients seeking to maintain their hearing while managing their tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife radiotherapy for vestibular schwannoma. Sakamoto, GT., Blevins, N., Gibbs, IC.[2018]

Single-fraction stereotactic radiosurgery (sfSRS) shows greater benefits than microsurgical resection (MR) for patients with unilateral vestibular schwannoma, particularly in reducing facial palsy and improving hearing function, based on a review of three non-randomized trials involving 339 patients.

There were no significant differences in mortality, vertigo, headaches, tinnitus, balance function, or quality of life between the two treatment methods, but the long-term effectiveness of sfSRS remains uncertain due to a lack of extended follow-up studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction stereotactic radiosurgery versus microsurgical resection for the treatment of vestibular schwannoma: a systematic review and meta-analysis. Jakubeit, T., Sturtz, S., Sow, D., et al.[2022]

Radiosurgery (RS) and stereotactic radiotherapy (SRT) both achieve high tumor control rates of around 90% for managing vestibular schwannoma (VS), with low side effect rates between 1-7%, making RS a preferred treatment for small, progressing tumors.

The management of VS should be interdisciplinary, with treatment decisions based on patient symptoms and tumor growth, emphasizing the importance of an initial 'wait and scan' strategy for incidental findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiosurgery and fractionated stereotactic radiotherapy of vestibular schwannoma]. Hamm, K., Herold, HU., Surber, G., et al.[2020]

Stereotactic radiosurgery (SRS) and fractionated stereotactic radiotherapy (FSRT) both show low rates of treatment failure for vestibular schwannoma, with progression-free survival rates between 92-100% for both methods, based on a systematic review of 19 case series.

SRS has a lower risk of facial nerve deterioration (3.6%) compared to FSRT (11.2%), suggesting that SRS may be a safer option for preserving nerve function in patients with vestibular schwannoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery vs. fractionated radiotherapy for tumor control in vestibular schwannoma patients: a systematic review. Persson, O., Bartek, J., Shalom, NB., et al.[2022]

Stereotactic radiotherapy (SRT) is an effective precision treatment for vestibular schwannomas, which are benign tumors affecting the eighth cranial nerve.

The review discusses both conventional and hypofractionated SRT regimens, highlighting their clinical outcomes and the underlying radio-biologic principles that support their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for vestibular schwannoma. Sweeney, P., Yajnik, S., Hartsell, W., et al.[2018]

In a study of 162 patients treated with stereotactic radiosurgery for acoustic neuromas, the tumor control rate was an impressive 98%, with 62% of tumors shrinking over time.

Radiosurgery successfully preserved normal facial function in 79% of patients and trigeminal function in 73%, demonstrating its efficacy in maintaining neurologic function long-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes after radiosurgery for acoustic neuromas. Kondziolka, D., Lunsford, LD., McLaughlin, MR., et al.[2022]

Stereotactic radiosurgery using Gamma Knife for treating vestibular schwannoma is effective and safe, with a 5-year progression-free survival rate of 87% and a 10-year rate of 81% based on a study of 333 patients over an average follow-up of 60 months.

The study identified that 39.3% of patients experienced pseudo-progression, which can complicate the assessment of treatment outcomes, highlighting the importance of understanding this phenomenon to avoid misinterpreting tumor recurrence and to guide follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic radiosurgery for vestibular schwannoma: early and long-term radiation-induced changes and tumor growth control]. Ilyalov, SR., Banov, SM., Golanov, AV., et al.[2022]

Stereotactic radiosurgery is becoming a preferred treatment option for patients with acoustic neuromas, as it offers a non-invasive alternative to open surgical resection.

The report reviews the evolution of radiosurgery techniques and discusses the indications and expected outcomes, suggesting that ongoing research will continue to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acoustic neuroma radiosurgery. Origins, contemporary use and future expectations. Kondziolka, D., Lunsford, LD., Flickinger, JC.[2018]

In a study of 452 patients who underwent gamma knife radiosurgery for vestibular schwannomas, only 2.9% required delayed microsurgery, indicating that failed radiosurgery is rare.

The difficulty of subsequent microsurgery varied, with most surgeons finding it more challenging than typical procedures, and outcomes showed that while some patients retained good facial function, others experienced significant complications, highlighting the need for careful evaluation before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular schwannoma management. Part II. Failed radiosurgery and the role of delayed microsurgery. Pollock, BE., Lunsford, LD., Kondziolka, D., et al.[2004]

Citations

1. academic.oup.com academic.oup.com/ptj/article/104/10/pzae085/7710184

Vestibular Rehabilitation: Improving Symptomatic and ... Twenty-three studies were included. Overall, the effect of vestibular physical therapy for patients with vestibular schwannoma was uncertain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11277882/

Customized Vestibular Rehabilitation for ... - PubMed Central The purpose of this study is to assess the impact of our rehabilitation program in adult patients who had vestibular schwannoma excision ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9835658/

Vestibular Complaints Impact on the Long-Term Quality of Life ... There is good evidence that vestibular rehabilitation exercises have a beneficial effect on the functional outcome after unilateral vestibular ...

4. researchgate.net researchgate.net/publication/382140416_Vestibular_Rehabilitation_Improving_Symptomatic_and_Functional_Outcomes_of_Persons_with_Vestibular_Schwannoma_A_Systematic_Review

(PDF) Vestibular Rehabilitation: Improving Symptomatic ... Overall, the effect of vestibular physical therapy for patients with vestibular schwannoma was uncertain. Outcomes of dizziness, static and ...

5. journals.lww.com journals.lww.com/jnpt/fulltext/2022/04000/vestibular_rehabilitation_for_peripheral.7.aspx

Journal of Neurologic Physical Therapy There is strong evidence supporting vestibular physical therapy for reducing symptoms, improving gaze and postural stability, and improving function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9991522/

Surgical Outcomes Following Vestibular Schwannoma ... Although SRS can achieve tumor control in 94% of patients at 10 years, only 69% achieve tumor control if the VS demonstrates growth of >2.5 mm per year prior to ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875017301468

Microsurgical Outcomes After Gross Total Resection on ... This study showed that elderly patients with VS did not experience more complications or worse function than their younger counterparts after microsurgical GTR.

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-017-0805-6

Functional outcome and complications after the microsurgical ... The favorable postoperative function of FN was achieved in 47.6 to 92.8% of vestibular schwannoma patients trans-suboccipital retrosigmoid ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4899411/

Surgical treatment of acoustic neuroma: Outcomes and ... When gross total resections are performed, the recurrence rate has ranged from 2.4% to 3%.15, 16 The rate of residual-recurrent tumor after complete resection ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMc2108279

Vestibular Schwannomas For large vestibular schwannomas, a “nerve-centered approach” with planned intracapsular resection offers equivalent functional outcomes but may ...