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Investigator's choice of anti-cancer treatment · 1 trial · 1 indication
A participant will be considered as successful in terms of the feasibility of using ZEMY if she has completed at least three symptom reported connections and if the rate of completed symptom reported connections for this participant is ≥ 60%.
| Arm | Type | Description |
|---|---|---|
| ZEMY software | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZEMY software | DEVICE | The ZEMY software medical device integrates specific algorithms based on international and validated guidelines. It provides individually customized information and defines for the patient an adapted action to follow for each of the following reported symptoms or anti-cancer treatment-related toxicities: diarrhea, fatigue, nausea, vomiting, cutaneous and mucosal toxicities, pain, fever/febrile neutropenia, high blood pressure, anxiety and depression. During the 3-month study period, participants will be asked to enter their symptoms among the 10 symptoms listed in ZEMY on their smartphone dedicated to the study. Consequently, ZEMY software will provide to the participants adapted real-time information to advise them on the management of the experienced symptom and recommend hygienic-dietetic advice and symptomatic treatments. |
| Investigator's choice of anti-cancer treatment (except immunotherapy) | DRUG | All anti-cancer treatments (except immunotherapy) will be left to the free choice of investigators. Participants shall be prescribed by the healthcare team both of the following symptomatic treatments: loperamide or any other anti-diarrheic treatment in case of diarrhea; and a prescription for any medication indicated in case of nausea/vomiting. A written prescription will be made by the investigator at screening for loperamide or any other anti-diarrheic treatment and symptomatic treatment for nausea/vomiting with documented dosage and duration. |
Inclusion Criteria: * 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...
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Investigator's choice of anti-cancer treatment refers to the anti-cancer therapy selected by the treating physician for a participant in a clinical study. In this program it was studied in female participants with breast cancer, within a Phase 2 trial conducted in France.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with this program. The treatment is an investigator-selected anti-cancer therapy, meaning the specific agent given to each participant is chosen by the treating physician rather than fixed by the study protocol.
Investigator's choice of anti-cancer treatment was evaluated in a Phase 2 study. That trial has been completed, and the program is not currently listed with active trials. It is an investigational approach studied in clinical research rather than an approved product.
The program was studied in NCT03558490, titled A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment. The Phase 2 trial enrolled 56 female participants aged 18 years and older in France and has been completed.
NCT03558490 was a Phase 2, uncontrolled study, so all 56 enrolled participants received treatment under the investigator's choice approach rather than being assigned to a comparator arm. It was not randomized and not double blinded, and it enrolled female participants with breast cancer in France.