Evidence map›Paper›PMID 38280118›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2024

Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation.

Robert Wakolbinger-Habel, Matthias Reinweber, Mahmoud Alakraa, Ingrid Riener, Brigitte Elisabeth Scheffold, Krisztina Racz, Flonza Selimi, Claudia Straub, Jakob Jauker, Walter Bily and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06048471 (High Tone Therapy for Chemotherapy Induced Neuropathy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06048471 nacompletednot on this map

High Tone Therapy for Chemotherapy Induced Neuropathy

TypeinterventionalSponsorVienna Hospital AssociationRan2020 to 2023Enrolled14ConditionsChemotherapy-induced Peripheral Neuropathy, Electrical StimulationArmsHiTop
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Robert Wakolbinger-HabelDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
Matthias ReinweberVienna Healthcare Group-Directorate General, Thomas-Klestil-Platz 7, 1030, Vienna, Austria.
Mahmoud AlakraaVienna Healthcare Group-Directorate General, Thomas-Klestil-Platz 7, 1030, Vienna, Austria.
Ingrid RienerDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
Brigitte Elisabeth ScheffoldDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
Krisztina RaczMedical Department II, Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
Flonza SelimiMedical Department II, Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
Claudia StraubDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Ottakring, Montleartstraße 37, 1160, Vienna, Austria.
Jakob JaukerDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Ottakring, Montleartstraße 37, 1160, Vienna, Austria.
Walter BilyExternal Lecturer, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Dora Niedersüß-BekeMedical Department I, Vienna Healthcare Group - Clinic Ottakring, Montleartstraße 37, 1160, Vienna, Austria.
Karl MayrhoferMedical Department I, Vienna Healthcare Group - Clinic Ottakring, Montleartstraße 37, 1160, Vienna, Austria.
Tatjana Paternostro-SlugaDepartment of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria. tatjana.paternostro-sluga@gesundheitsverbund.at.
Medical University of Vienna · ATDonauspital · ATTU Wien · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost oncologic patients receiving chemotherapy suffer from neuropathy, which not only severely affects quality of life but also may lead to chemotherapy dose reductions or even discontinuation of cancer therapy. Still, it is difficult to sufficiently control these symptoms with the currently available pharmacological treatments. High tone therapy was reported to be an effective option for neuropathies due to different etiologies. However, to date, there are no studies on high tone therapy in patients with chemotherapy-induced peripheral neuropathy.

methodsThis randomized, double-blind, and placebo-controlled two-center study was conducted at the Departments of Physical and Rehabilitation Medicine at the Clinics Donaustadt and Ottakring, Vienna, Austria. Patients with histologically verified colorectal carcinoma treated with a platin derivate and neuropathic symptoms were invited to participate. High tone therapy took place in a home-based setting using the HiToP 191 PNP ® or placebo device for three weeks. Neuropathic symptoms and quality of life were assessed via questionnaires. After the follow-up examination, an opt-in was offered to the patients in the placebo group in terms of an open-label treatment with a verum HiToP PNP ® device. In addition, patients with chemotherapy-induced peripheral neuropathy due to various malignant diseases were treated in an open-label setting reflecting a clinical application observation. These patients are reported as a separate group.

resultsIn the verum group, there was a significant reduction of paresthesias and mental stress due to paresthesias from baseline until end of therapy, compared to placebo. These findings were observed in the opt-in subgroup, as well. In the open-label clinical application observation group, intensity and mental stress due to paresthesia, pain, cramps, and intensity of tightness/pressure were significantly lower at the end of therapy, compared to baseline.

conclusionsHome-based high tone therapy brought about a significant alleviation in paresthesias and mental stress due to paresthesias in the verum but not the placebo group. In the clinical application observation, a significant alleviation in several further neuropathic symptoms was seen.

trial registrationThis study was registered at clinicaltrials.gov (NCT06048471, 03/02/2020).

Indexed as

Antineoplastic AgentsColorectal NeoplasmsPeripheral Nervous System DiseasesDouble-Blind MethodHumansParesthesiaPilot ProjectsQuality of LifeAntineoplastic AgentsChemotherapy-induced peripheral neuropathyHigh tone therapyPhysical medicineRehabilitation

Identifiers

PMID38280118
PMCPMC10821972
OpenAlexW4391276081

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.