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Search / Trial NCT06552091

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

Launched by INSTITUT DE CANCÉROLOGIE DE LORRAINE · Aug 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Non Metastatic Hormone Therapy Hot Flashes Self Hypnosis

ClinConnect Summary

This clinical trial is studying whether a daily guided self-hypnosis program can help reduce hot flashes in women undergoing hormone therapy for non-metastatic breast cancer. Hot flashes are a common side effect of the treatment and can significantly affect a patient's quality of life and ability to stick to their prescribed medication. By using a digital self-hypnosis solution, the trial aims to see if it can help women feel better and improve their overall treatment experience.

To participate in this study, women aged 65 to 74 who are currently being treated for non-metastatic breast cancer and experience at least 50 hot flashes a week may be eligible. Participants will take part in guided self-hypnosis sessions over three weeks, focusing on different themes. They will also provide feedback on their quality of life, sleep quality, and satisfaction with care. This trial not only hopes to help manage hot flashes but also to enhance the participants' overall well-being during their treatment journey.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Adult patient,
  • WHO ≤ 2,
  • Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis,
  • Patient being treated for non-metastatic breast cancer,
  • Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4/6 targeted therapy,
  • Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day
  • Patient has a computer device capable of accessing the self-hypnosis program link,
  • Information provided and informed consent signed,
  • Patient affiliated with the social security system.
  • Exclusion Criteria:
  • Male,
  • Patient with hearing impairments,
  • Patient with psychotic and/or cognitive disorders As assessed by the clinician,
  • Patient who does not understand the French language,
  • Patient not diagnosed with non-metastatic breast cancer,
  • Patient not undergoing anti-aromatase treatment,
  • Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day,
  • Prior participation in a hypnosis or self-hypnosis program before inclusion,
  • Patient participating in a therapeutic program related to hot flashes,
  • Patient already included in another therapeutic trial on the same topic,
  • Patient already included in another therapeutic trial with an experimental drug,
  • Pregnant or breastfeeding woman,
  • Patient deprived of liberty (including guardianship and curatorship).

About Institut De Cancérologie De Lorraine

The Institut de Cancérologie de Lorraine (ICL) is a leading cancer research and treatment center in France, dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. With a focus on multidisciplinary collaboration, ICL integrates cutting-edge research with clinical practice to enhance therapeutic outcomes and improve the quality of life for cancer patients. The institute is committed to fostering scientific discovery and translating findings into effective treatments, while adhering to the highest ethical standards in clinical research. Through its robust portfolio of clinical trials, ICL aims to contribute significantly to the understanding and management of various cancer types.

Locations

Vandœuvre Lès Nancy, , France

Patients applied

0 patients applied

Trial Officials

AURELIEN AL LAMBERT, MD

Principal Investigator

Institut de Cancérologie de Lorraine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported