Chemotherapy Induced Peripheral NeuropathyPhase 2NCT02773329
Using Game-based Exercise to Improve Balance in Cancer Patients
A Phase 2 study testing sensor-based interactive exercise (game-based exercise) and Intervention without game-based exercise in people with Chemotherapy Induced Peripheral Neuropathy and Cancer, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy, Cancer
- What is being tested?
- sensor-based interactive exercise (game-based exercise) and Intervention without game-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2019
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients
- Men or women aged 55 years or older
- Patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons)
- Confirmed peripheral neuropathy (VPT>25) will be eligible to participate
Who cannot join
- Subjects will be excluded if they have undergone surgery in the last 6-8 weeks
- Have Parkinson's Disease
- Stroke patients
- Dementia patients
- Have an active foot ulcer
- Have an active infection
Show all 10Show fewer
- Lower extremity major amputation
- Patient is taking medications unrelated to cancer treatment that may affect balance and gait
- Patient has other medical conditions that may affect their balance and gait
- Patient is unable to ambulate without assistance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. This study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. Investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.
- Conditions
- Chemotherapy Induced Peripheral Neuropathy, Cancer
- Being tested
- sensor-based interactive exercise (game-based exercise), Intervention without game-based exercise
- Keywords
- chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor-based interactive exercise (game-based exercise)Other
Also called virtual reality exercise
This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action.
Intervention without game-based exerciseOther
Also called non-technology based exercise
Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with game-based exercise | Experimental | Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks. Receives: Other: sensor-based interactive exercise (game-based exercise) |
| Intervention without game-based exercise | Active comparator | Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks Receives: Other: Intervention without game-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed change from Baseline to 6 weeks, three months and six months
walking ability is quantified by gait speed.
Measured: Baseline, 6 weeks, three months, six months
Balance change from Baseline to 6 weeks, three months and six months
balance is quantified by body sway
Measured: Baseline, 6 weeks, three months, six months
Secondary outcomes (1)
Fear of falling change from Baseline to 6 weeks
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773329
- Sponsor's protocol ID
- H-38347
- Status last verified
- Jun 2019
- First submitted
- 9 May 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
Publications
Schwenk M, Grewal GS, Holloway D, Muchna A, Garland L, Najafi B. Interactive Sensor-Based Balance Training in Older Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2016;62(5):553-63. doi: 10.1159/000442253. Epub 2015 Dec 18.
PubMed 26678611Zahiri M, Chen KM, Zhou H, Nguyen H, Workeneh BT, Yellapragada SV, Sada YH, Schwenk M, Najafi B. Using wearables to screen motor performance deterioration because of cancer and chemotherapy-induced peripheral neuropathy (CIPN) in adults - Toward an early diagnosis of CIPN. J Geriatr Oncol. 2019 Nov;10(6):960-967. doi: 10.1016/j.jgo.2019.01.010. Epub 2019 Jan 18.
PubMed 30665876
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
- ClinicalTrials.gov ID
- NCT02773329
- Acronym / sponsor ID
- H-38347
- Conditions
- Chemotherapy Induced Peripheral Neuropathy, Cancer
- Keywords
- chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 May 2016 (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.
Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. This study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. Investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with game-based exercise | Experimental | Other: sensor-based interactive exercise (game-based exercise)Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks. |
| Intervention without game-based exercise | Active comparator | Other: Intervention without game-based exerciseSubjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients
- Men or women aged 55 years or older
- Patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons)
- Confirmed peripheral neuropathy (VPT>25) will be eligible to participate
Key exclusion criteria (10 listed)
- Subjects will be excluded if they have undergone surgery in the last 6-8 weeks
- Have Parkinson's Disease
- Stroke patients
- Dementia patients
- Have an active foot ulcer
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 |
|---|---|---|
| sensor-based interactive exercise (game-based exercise)Also: virtual reality exerciseThis intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. | Other | Intervention with game-based exercise |
| Intervention without game-based exerciseAlso: non-technology based exerciseSubjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks. | Other | Intervention without game-based exercise |
Primary outcome
Gait Speed change from Baseline to 6 weeks, three months and six months
Time frame: Baseline, 6 weeks, three months, six months
walking ability is quantified by gait speed.
Balance change from Baseline to 6 weeks, three months and six months
Time frame: Baseline, 6 weeks, three months, six months
balance is quantified by body sway
1 secondary outcome
Fear of falling change from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Results publication: PubMed 26678611Schwenk M, Grewal GS, Holloway D, Muchna A, Garland L, Najafi B. Interactive Sensor-Based Balance Training in Older Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2016;62(5):553-63. doi: 10.1159/000442253. Epub 2015 Dec 18.
- Results publication: PubMed 30665876Zahiri M, Chen KM, Zhou H, Nguyen H, Workeneh BT, Yellapragada SV, Sada YH, Schwenk M, Najafi B. Using wearables to screen motor performance deterioration because of cancer and chemotherapy-induced peripheral neuropathy (CIPN) in adults - Toward an early diagnosis of CIPN. J Geriatr Oncol. 2019 Nov;10(6):960-967. doi: 10.1016/j.jgo.2019.01.010. Epub 2019 Jan 18.
- obstacle crossing exergameLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sensor-based interactive exercise (game-based exercise) and Intervention without game-based exercise in people with Chemotherapy Induced Peripheral Neuropathy and Cancer, run by Baylor College of Medicine at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 26 Jun 2019. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed change from Baseline to 6 weeks, three months and six months (time frame: Baseline, 6 weeks, three months, six months). The study lists 2 primary outcomes in all. 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 NCT02773329, which also lists 2 linked publications.
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 26 Jun 2019.