Completed

ZEMYFeasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment

What is being tested

ZEMY software

+ Investigator's choice of anti-cancer treatment (except immunotherapy)

DeviceDrug

Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Phase 2

Interventional

Study Start: June 2018

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 12, 2018

Actual date on which the first participant was enrolled.

This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.

Official TitleFeasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment

NCT03558490

Principal SponsorHoffmann-La Roche

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

6 inclusion criteria required to participate

Female patients with breast cancer starting a treatment including oral and/or parenteral anti-cancer drugs (chemotherapy and/or targeted therapies, hormonotherapy)

Inter-cycle duration between hospital visits ≥14 days (this period of time is estimated to be consistent with a need for support during the home setting period)

Patients shall be prescribed loperamide or any other anti-diarrheic treatment in case of diarrhea and prescription for any medication indicated in case of nausea/vomiting

Able to speak and read French and to use a smartphone embedding ZEMY, in the investigator's judgment

Show More Criteria

9 exclusion criteria prevent from participating

Pregnant

Already enrolled in a clinical study involving experimental medication or eHealth device

Concomitant malignancy

ECOG score >2

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Centre Francois Baclesse; Oncologie

Caen, FranceOpen Centre Francois Baclesse; Oncologie in Google Maps

Suspended

Centre Jean Perrin; Oncologie

Clermont-Ferrand, France

Suspended

Hopital Prive Jean Mermoz; Cancerologie

Lyon, France

Suspended

Hopital Saint Louis; Oncologie Medicale

Paris, France

Completed5 Study Centers