Chemotherapy-induced Peripheral NeuropathyNCT06048471
High Tone Therapy for Chemotherapy Induced Neuropathy
A study testing HiTop in people with Chemotherapy-induced Peripheral Neuropathy and Electrical Stimulation, run by Vienna Hospital Association at 1 site in Austria.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Electrical Stimulation
- What is being tested?
- HiTop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2020to 22 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9.
- Cumulative dose of at least 3 cycles
- Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects
- Life expectancy of at least 3 months
- Stable medication (no changes of especially pain medication during the study)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying)
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- Ability to walk (with or without aids)
- European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2
- Intensity of paresthesias of 3/10 or higher on the Numeric Rating Scale (NRS)
Who cannot join
- Prevalent neuropathy of different etiology
- Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators
- Epilepsy
- Minors or persons unable to give informed consent
- Current neurotoxic medication
- Implanted pacemakers or defibrillators
Show all 9Show fewer
- Pregnancy
- Wounds in the area to be treated, acute local or systemic infection
- Peripheral arterial occlusive disease > grade 2
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment.
Patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these Symptoms.
Read more
High tone therapy / high tone external muscle stimulation (HTEMS) seems to be an effective treatment for neuropathic symptoms. Previous studies observed promising results in diabetics and chronic kidney disease (CKD) patients.
To date, there is no investigation on HTEMS in patients with chemotherapy induced neuropathy.
Therefore, this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment.
The primary objective is the alleviation of paresthesias. The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.
- Being tested
- HiTop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiTopOther
High tone transcutaneous electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| HiTop | Experimental | Not described Receives: Other: HiTop |
| Sham stimulation | Sham comparator | Not described Receives: Other: HiTop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of paresthesia
NRS scale
Measured: 5 weeks
Secondary outcomes (1)
health related Quality of life (QOL), detailed symptroms of neuropathy
EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Apr 2020
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Hospital Association
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048471
- Sponsor's protocol ID
- HiTop Protocol v.1.3
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wakolbinger-Habel R, Reinweber M, Alakraa M, Riener I, Scheffold BE, Racz K, Selimi F, Straub C, Jauker J, Bily W, Niedersuss-Beke D, Mayrhofer K, Paternostro-Sluga T. Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation. Support Care Cancer. 2024 Jan 27;32(2):134. doi: 10.1007/s00520-024-08331-7.
PubMed 38280118
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Tone Therapy for Chemotherapy Induced Neuropathy
- ClinicalTrials.gov ID
- NCT06048471
- Acronym / sponsor ID
- HiTop Protocol v.1.3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vienna Hospital AssociationOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- 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), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment.
Patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these Symptoms.
High tone therapy / high tone external muscle stimulation (HTEMS) seems to be an effective treatment for neuropathic symptoms. Previous studies observed promising results in diabetics and chronic kidney disease (CKD) patients.
To date, there is no investigation on HTEMS in patients with chemotherapy induced neuropathy.
Therefore, this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment.
The primary objective is the alleviation of paresthesias. The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HiTop | Experimental | Other: HiTop |
| Sham stimulation | Sham comparator | Other: HiTop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9.
- Cumulative dose of at least 3 cycles
- Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects
- Life expectancy of at least 3 months
- Stable medication (no changes of especially pain medication during the study)
Key exclusion criteria (9 listed)
- Prevalent neuropathy of different etiology
- Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators
- Epilepsy
- Minors or persons unable to give informed consent
- Current neurotoxic medication
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 |
|---|---|---|
| HiTopHigh tone transcutaneous electrical stimulation | Other | HiTop, Sham stimulation |
Primary outcome
Intensity of paresthesia
Time frame: 5 weeks
NRS scale
1 secondary outcome
health related Quality of life (QOL), detailed symptroms of neuropathy
Time frame: 5 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 10 Oct 2023.
- Derived from this study: PubMed 38280118Wakolbinger-Habel R, Reinweber M, Alakraa M, Riener I, Scheffold BE, Racz K, Selimi F, Straub C, Jauker J, Bily W, Niedersuss-Beke D, Mayrhofer K, Paternostro-Sluga T. Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation. Support Care Cancer. 2024 Jan 27;32(2):134. doi: 10.1007/s00520-024-08331-7.
- Individual participant dataSharing planned: No
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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 study testing HiTop in people with Chemotherapy-induced Peripheral Neuropathy and Electrical Stimulation, run by Vienna Hospital Association at 1 site in Austria.
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 9 inclusion and 9 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 10 Oct 2023. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
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?
Intensity of paresthesia (time frame: 5 weeks). 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 NCT06048471, 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 10 Oct 2023.