NCT06048471

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3.5 years

First QC Date

March 2, 2020

Last Update Submit

October 8, 2023

Conditions

Chemotherapy-induced Peripheral NeuropathyElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Intensity of paresthesia

    NRS scale

    5 weeks

Secondary Outcomes (1)

  • health related Quality of life (QOL), detailed symptroms of neuropathy

    5 weeks

Study Arms (2)

HiTop

EXPERIMENTAL
Other: HiTop

Sham stimulation

SHAM COMPARATOR
Other: HiTop

Interventions

HiTopOTHER

High tone transcutaneous electrical stimulation

HiTopSham stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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)

You may not qualify if:

  • 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
  • Pregnancy
  • Wounds in the area to be treated, acute local or systemic infection
  • Peripheral arterial occlusive disease \> grade 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Donaustadt

Vienna, 1220, Austria

Location

Related Publications (1)

  • 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.

    PMID: 38280118DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

September 21, 2023

Study Start

April 1, 2020

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)