No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
16 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for adults who have experienced nerve damage in their hands from chemotherapy. Participants will use a hand-held vibrating device for three minutes each day to see if it helps reduce their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I can provide informed consent.
I completed chemotherapy at least 60 days ago.
I was treated with specific neurotoxic chemotherapy drugs.
I have ongoing hand nerve damage rated as Grade 2 or higher.
I have non-metastatic solid tumor cancer.
I agree to return to the clinic for measurements.
You may not be able to join if
I have a different condition causing hand neuropathy.
I have diabetes.
I have known issues that prevent me from using vibration therapy.
I am receiving radiation therapy for my upper body.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early d…
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. 18 years or older at enrollment
2. Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
3. Have completed chemotherapy ≥ 60 days prior to enrollment
4. Were exposed to neurotoxic chemotherapy with one or more of the fo…
Inclusion Criteria:
1. 18 years or older at enrollment
2. Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
3. Have completed chemotherapy ≥ 60 days prior to enrollment
4. Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m)
5. Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy
6. If solid tumor cancer, must have non-metastatic cancer
7. Agree to return to clinic for required study related measurements at specified intervals
Exclusion Criteria:
1. Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
2. Known diagnosis of diabetes mellitus.
3. Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
4. Will be receiving concurrent radiation of the upper-extremity
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