Last reviewed · How we verify

NCT06552091: HYBOU

Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy

Recruiting now NA Last updated 17 February 2026
What this trial tests

NA trial testing self-hypnosis sessions in Breast Cancer Female in 76 participants. Currently enrolling.

Timeline
17 October 2024
Primary endpoint
30 April 2026
17 February 2027

Quick facts

Lead sponsorInstitut de Cancérologie de Lorraine
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment76
Start date17 October 2024
Primary completion30 April 2026
Estimated completion17 February 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut de Cancérologie de Lorraine — full company profile →

Who can join

18 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health. Some side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient. Our hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence. The principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy. The secondary objectives are to evaluate : * Patient adherence to guided self-hypnosis via a digital solution * Quality of life * Sleep quality * Satisfaction with care * Usability of the digital tool The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

Other Institut de Cancérologie de Lorraine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06552091.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing