The Mamma HiToP Study

NCT06132776 | Recruiting DMC

• 1 other identifier: CIP_Mamma 1.1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia. The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. The study is multicenter, randomized, double-blind, and placebo-controlled. Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Alleviation of paresthesias (VAS)

  Visual analog scale, 0-10, higher score = worse

  baseline vs. one day after the last treatment session

Secondary Outcomes (3)

• Further neuropathic symptoms (via VAS questionnaire)

  baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session

• Further neuropathic symptoms (via EORCT CIPN20 questionnaire)

  baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session

• Quality of life (via EORCT C30 questionnaire)

  baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session

Study Arms (2)

Verum group

EXPERIMENTAL

Device: HiToP 191 PNP

Placebo group

PLACEBO COMPARATOR

Device: Placebo device

Interventions

HiToP 191 PNP DEVICE

High tone therapy

Verum group

Placebo device DEVICE

Placebo therapy

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with histologically verified breast cancer and neoadjuvant or adjuvant treatment with a taxane derivate (e.g., Paclitaxel, Docetaxel): 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
• 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 on the Visual Analog Scale (VAS)

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

Sponsors & Collaborators

• Vienna Hospital Association: lead

Study Sites (1)

Clinics Donaustadt, Ottakring, Hietzing

Vienna, Austria

RECRUITING

Study Officials

• Tatjana Paternostro-Sluga, MD

  Vienna Healthcare Group

  STUDY DIRECTOR

Central Study Contacts

Robert Wakolbinger-Habel, MD, PhD

CONTACT

+43 1 28802 4604; robert.wakolbinger-habel@gesundheitsverbund.at

Brigitte E Scheffold, MD, MSc, MSc

CONTACT

+43 1 28802 4604; brigitteelisabeth.scheffold@gesundheitsverbund.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 15, 2023
• Study Start: November 3, 2023
• Primary Completion: November 2, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

AU (1)