Chemotherapy-induced Peripheral NeuropathyVANISHNCT03032718
Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy
A study testing Whole-body vibration training in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Basel at 1 site in Switzerland.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Whole-body vibration training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- oncological patients with neurologically confirmed CIPN
- age: 18-80 years
- performance status of 0-2 according to the toxicity and response criteria of the Eastern Cooperative Oncology Group
- patients underwent neurotoxic chemotherapy with one of the following agents: Taxanes (docetaxel with a cumulative dose of ≥ 225mg/m2 or paclitaxel with a cumulative dose of ≥ 525mg/m2), Vinca-alkaloids (vincristine with a cumulative dose of ≥ 4.2mg/m2 or vinblastine with a cumulative dose of 24mg/m2), Platinum-derivatives (Oxaliplatin with a cumulative dose of ≥ 510mg/m2, Cisplatinum with a cumulative dose of ≥ 200mg/m2)
Who cannot join
- pre-existing neuropathy of other cause (e.g. diabetes)
- given contraindications for WBV (instable osteolysis, osteosynthesis, acute thrombosis, foot ulcers and a fracture of a lower extremity in the last two years)
- a myocardial infarction, angina pectoris or heart disease (NYHA III-IV) within the past six months
- a mental condition or lack of the German language that prevents the understanding of the written informed consent
- metastases of the central nervous system and epilepsy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel
Basel, 4052
Fiona Streckmann, PhD, fiona.streckmann@unibas.ch
About this study
Official title: Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking.
Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits.
Read more
We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up.
We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.
- Being tested
- Whole-body vibration training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration trainingBehavioural
Whole-body vibration exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in the intervention group will receive a defined exercise program twice a week in addition to their usual treatment. Training sessions start immediately after randomization and will be supervised by trained sport students. They will take place twice a week, for twelve weeks in specific training rooms designed to meet the needs of oncological patients in the respective centers. The vibration exercises will take place on a side-alternating vibration platform (GalileoTM, Pforzheim, Germany) ®) according to the previously determined optimal (highest neuromuscular response) setting for each individual. Each session will last for about 15 to 30 minutes, leaving sufficient time for regeneration. Training will consist of four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions will be documented by the supervisor. Receives: Behavioral: Whole-body vibration training |
| Control | No intervention | Patients in the control group will receive treatment as usual and will be given the opportunity to participate in the intervention after completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]
It will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. This questionnaire has been validated and is widely applied in clinical practise. It contains eleven items which allow an assessment of the extent of PNP symptoms - from "not at all" to "very much".
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary outcomes (14)
Compound muscle action potentials (CMAP)
obtained from the tibial and peroneal nerve
Measured: Baseline
Distal motor latency
obtained from the tibial and peroneal nerve
Measured: Baseline
Nerve conduction velocity
obtained from the tibial and peroneal nerve
Measured: Baseline
Sensory nerve action potentials (SNAPs)
recorded from the lateral malleolus with surface electrodes
Measured: Baseline
Peripheral deep sensitivity
evaluated with a Rydel-Seiffer tuning fork (128Hz) on a scale from 0 to 8; due to age related neural deconditioning, values ≤4 are pathological for patients ≥ 60years old, while for patients under 60 years old, ≤5 is regarded as pathological
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Reflex action
The Achilles tendon reflex as well as the patellar tendon reflex is assessed with a reflex hammer and graded on a 3 point scale (1=agile, 2=weak, 3=missing).
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Sense of position
This test examines whether patients can recognize a change of position in their first toe, with their eyes closed.
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Perception of touch
The examiner symmetrically strokes the outsides of the patients' legs and feet in order to detect reduced or altered sensation due to demyelination or axonal degeneration.
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Muscular strength
The strength of the leg muscles is assessed by requesting the patient to actively move their legs against the resistance of the examiner's arm. The examiner then grades the strength on a six point scale (0=no activity, 1=visual contraction without motor effect, 2=movement under elimination of gravity, 3=movement under gravity, 4=movement against slight resistance 5=normal force).
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
EMG recordings
Normalized (to static standing without vibration condition) integrated EMG activity of mm. tibialis anterior, soleus, gastrocnemius (medial head), mm. rectus femoris, vastus medialis, biceps femoris. EMG recordings will be performed using bipolar Ag/AgCl surface electrodes placed over the mm. soleus, gastrocnemius medialis, tibialis anterior, rectus femoris, vastus medialis and biceps femoris of the right leg. A reference electrode will be placed on the patella. To keep interelectrode resistance below 2 kOhm, the skin areas for the electrodes will have to be shaved, degreased and slightly abraded. The EMG signals will then be transmitted to the amplifier (band-pass filter 10 Hz-1 kHz, 1,0009 amplified) via shielded cables and recorded with 4 kHz.
Measured: 1 week (first 2 training sessions)
CIPN-related pain
Visual analogue scale (VAS) in order to assess neuropathic pain as well as the dysesthesias
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Postural control
Center of pressure during upright static and dynamic stance
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Quality of life - questionnaire
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Physical activity questionnaire
Measured: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne, University Hospital of Cologne, University of Freiburg, University Hospital, Basel, Switzerland
- Responsible party
- Principal investigator, Oliver Faude, University of Basel
- Investigators
- Fiona Streckmann, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032718
- Sponsor's protocol ID
- 2016-01527
- Other IDs
- 2016
- Acronym
- VANISH
- Status last verified
- Mar 2017
- First submitted
- 19 Jan 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Streckmann F, Hess V, Bloch W, Decard BF, Ritzmann R, Lehmann HC, Balke M, Koliamitra C, Oschwald V, Elter T, Zahner L, Donath L, Roth R, Faude O. Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH. BMJ Open. 2019 Apr 24;9(4):e024467. doi: 10.1136/bmjopen-2018-024467.
PubMed 31023750
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03032718
- Acronym / sponsor ID
- VANISH / 2016-01527
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- German Sport University, Cologne, University Hospital of Cologne, University of Freiburg, University Hospital, Basel, Switzerland
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking.
Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits.
We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up.
We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Whole-body vibration trainingPatients in the intervention group will receive a defined exercise program twice a week in addition to their usual treatment. Training sessions start immediately after randomization and will be supervised by trained sport students. They will take place twice a week, for twelve weeks in specific training rooms designed to meet the needs of oncological patients in the respective centers. The vibration exercises will take place on a side-alternating vibration platform (GalileoTM, Pforzheim, Germany) ®) according to the previously determined optimal (highest neuromuscular response) setting for each individual. Each session will last for about 15 to 30 minutes, leaving sufficient time for regeneration. Training will consist of four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions will be documented by the supervisor. |
| Control | No intervention | –Patients in the control group will receive treatment as usual and will be given the opportunity to participate in the intervention after completion of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- oncological patients with neurologically confirmed CIPN
- age: 18-80 years
- performance status of 0-2 according to the toxicity and response criteria of the Eastern Cooperative Oncology Group
- patients underwent neurotoxic chemotherapy with one of the following agents: Taxanes (docetaxel with a cumulative dose of ≥ 225mg/m2 or paclitaxel with a cumulative dose of ≥ 525mg/m2), Vinca-alkaloids (vincristine with a cumulative dose of ≥ 4.2mg/m2 or vinblastine with a cumulative dose of 24mg/m2), Platinum-derivatives (Oxaliplatin with a cumulative dose of ≥ 510mg/m2, Cisplatinum with a cumulative dose of ≥ 200mg/m2)
Key exclusion criteria (5 listed)
- pre-existing neuropathy of other cause (e.g. diabetes)
- given contraindications for WBV (instable osteolysis, osteosynthesis, acute thrombosis, foot ulcers and a fracture of a lower extremity in the last two years)
- a myocardial infarction, angina pectoris or heart disease (NYHA III-IV) within the past six months
- a mental condition or lack of the German language that prevents the understanding of the written informed consent
- metastases of the central nervous system and epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body vibration trainingWhole-body vibration exercise | Behavioural | Intervention |
Primary outcome
FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
It will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. This questionnaire has been validated and is widely applied in clinical practise. It contains eleven items which allow an assessment of the extent of PNP symptoms - from "not at all" to "very much".
14 secondary outcomes
Compound muscle action potentials (CMAP)
Time frame: Baseline
Distal motor latency
Time frame: Baseline
Nerve conduction velocity
Time frame: Baseline
Sensory nerve action potentials (SNAPs)
Time frame: Baseline
Peripheral deep sensitivity
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Reflex action
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Sense of position
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Perception of touch
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Muscular strength
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
EMG recordings
Time frame: 1 week (first 2 training sessions)
CIPN-related pain
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Postural control
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Quality of life - questionnaire
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Physical activity questionnaire
Time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 31023750Streckmann F, Hess V, Bloch W, Decard BF, Ritzmann R, Lehmann HC, Balke M, Koliamitra C, Oschwald V, Elter T, Zahner L, Donath L, Roth R, Faude O. Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH. BMJ Open. 2019 Apr 24;9(4):e024467. doi: 10.1136/bmjopen-2018-024467.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Streckmann, PhD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body vibration training in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Faude, PhD (0041 61 2074735, oliver.faude@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity] (time frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.