Trial results for a mind-body intervention aimed at hot flash management were posted on ClinicalTrials.gov on 2025-06-05. The study, which included individuals with breast cancer, evaluated self-administered hypnosis, showing a mean hot flash score of 34.7 (Standard Deviation 34.4) in the hypnosis group compared to 52.8 (Standard Deviation 49.4) in the sham hypnosis group at the final measurement point.
Background
Hot flashes are a common and often disruptive symptom experienced by many individuals, particularly postmenopausal women and those undergoing treatment for breast cancer. For breast cancer patients, hormonal therapies or treatment-induced menopause can exacerbate these symptoms, making non-hormonal interventions particularly relevant. The long-term goal of this research program is to identify safe and effective non-hormonal strategies for managing menopausal symptoms, including hot flashes. This study specifically investigated the potential of self-administered hypnosis as such an intervention.
Trial design
This completed study, designated as Phase NA, enrolled 250 participants. The conditions investigated included Hot Flashes, Postmenopausal Symptoms, and Breast Cancer. The main objective was to assess whether self-administered hypnosis could significantly reduce hot flashes more effectively than self-administered white noise hypnosis over six weeks of home practice. The trial compared a Self-Administered Hypnosis intervention arm against a Self-Administered Sham Hypnosis (white noise hypnosis) comparator arm.
Key results
The study reported several key measurements for hot flash severity and interference:
- Hot Flash Daily Diary:
- For the Self-Administered Hypnosis group, the mean Hot Flash Score was 88.7 (Standard Deviation 61.3).
- For the Self-Administered Sham Hypnosis group, the mean Hot Flash Score was 94.6 (Standard Deviation 81.6).
- Another measurement for the Self-Administered Hypnosis group showed a mean Hot Flash Score of 41.3 (Standard Deviation 50.8).
- Another measurement for the Self-Administered Sham Hypnosis group showed a mean Hot Flash Score of 55.9 (Standard Deviation 50.9).
- A final measurement for the Self-Administered Hypnosis group showed a mean Hot Flash Score of 34.7 (Standard Deviation 34.4).
- A final measurement for the Self-Administered Sham Hypnosis group showed a mean Hot Flash Score of 52.8 (Standard Deviation 49.4).
- Hot Flash Related Daily Interference Scale:
- For the Self-Administered Hypnosis group, the mean score on a scale was 49.3 (Standard Deviation 22.6).
- For the Self-Administered Sham Hypnosis group, the mean score on a scale was 47.3 (Standard Deviation 22.4).
- Another measurement for the Self-Administered Hypnosis group showed a mean score on a scale of 25 (Standard Deviation 22.4).
- Another measurement for the Self-Administered Sham Hypnosis group showed a mean score on a scale of 29.6 (Standard Deviation 22).
- A final measurement for the Self-Administered Hypnosis group showed a mean score on a scale of 21.4 (Standard Deviation 20.2).
- A final measurement for the Self-Administered Sham Hypnosis group showed a mean score on a scale of 24.2 (Standard Deviation 20.3).
What this means
The results suggest that self-administered hypnosis may be a beneficial non-hormonal intervention for managing hot flashes. The consistent trend of lower mean hot flash scores and reduced daily interference in the self-administered hypnosis group compared to the sham hypnosis group indicates a potential positive effect. This is particularly relevant for individuals with breast cancer who often seek non-pharmacological options for symptom management due to treatment side effects or contraindications to hormonal therapies. Further analysis of these results, including statistical significance, would provide a clearer understanding of the clinical utility of this intervention.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03572153, titled "A Mind-Body Intervention for Hot Flash Management", were posted on 2025-06-05 on clinicaltrials.gov.