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Institut Claudius Regaud Launches Phase 2 Trial to Evaluate Medical Hypnosis for Reducing Anxiety in Solid Tumor Patients Undergoing Radiation Therapy

Institut Claudius RegaudΒ·ClinicalTrials.govΒ·April 20, 2026
Clinical
Institut Claudius Regaud Launches Phase 2 Trial to Evaluate Medical Hypnosis for Reducing Anxiety in Solid Tumor Patients Undergoing Radiation Therapy
✨AI SummaryAI

Evolution of Patient-Centric Supportive Care

Acute anxiety experienced by cancer patients during radiotherapy is a critical variable that directly impacts treatment compliance and clinical outcomes. The 'HYPNOMUSE' Phase 2 clinical trial, led by the Institut Claudius Regaud, a leading French cancer center, introduces non-pharmacological medical hypnosis to manage anxiety in patients with solid tumors. In conventional clinical settings, benzodiazepines such as lorazepam have been used for acute anxiety, but their long-term use is limited due to concerns about side effects such as drowsiness and drug dependence. This study aims to empower patients to control their psychological well-being during treatment, creating a treatment environment free of side effects.

Clinical Design and Key Evaluation Metrics

This Phase 2 trial (HYPNOMUSE, NCT04513444) involves 45 adult patients with solid tumors who are scheduled to undergo at least 15 radiotherapy sessions and report moderate or severe anxiety (STAI-Y score of 46 or higher). Patients are randomized into a standard arm (Arm A), which receives music listening therapy alone, and an experimental arm (Arm B), which receives music listening therapy combined with medical hypnosis. The primary outcome measure is defined as the proportion of patients who experience a clinically significant reduction of at least 10 points in their STAI-Y (State-Trait Anxiety Inventory) score from baseline to the last six sessions and during a two-month follow-up period. The study design stands out for its objective to standardize and quantify subjective changes in patients' emotional states using validated assessment tools.

Market Value and Significance of Non-Pharmacological Treatment

The global digital psychotherapeutics market is projected to grow rapidly from approximately $1.7 billion in 2025 to $19.7 billion in 2035, with an annual growth rate of 27.6%. The cancer supportive care market, which aims to ensure quality of life throughout the cancer treatment journey, is also expected to maintain steady growth, from $27.6 billion in 2024 to $31.4 billion in 2030. Non-invasive interventions such as medical hypnosis do not pose a risk of interaction with chemotherapy drugs, making them a safe option for patients with advanced solid tumors undergoing complex multi-drug regimens. This is ultimately considered an important tool for improving the overall safety of cancer treatment.

Future Market Prospects and Standardization of Integrated Treatment

This study began enrolling patients on December 7, 2020, and is currently recruiting, with an estimated completion date of August 2027. Driven by the recent trend of digital healthcare and patient support program adoption, the standardization of non-pharmacological anxiety reduction therapies is expected to accelerate. If this trial is successful and demonstrates the effectiveness of the treatment, it is highly likely that it will be officially included as a new supportive care protocol in existing standard radiotherapy guidelines. It can also contribute to reducing appointment cancellation rates and improving the overall operational efficiency and cost savings of healthcare institutions.

πŸ’¬Why It Matters

This study is an important testbed for obtaining Phase 2 clinical data on medical hypnosis, a non-pharmacological technique, in the cancer supportive care market, which is expected to grow to $31.4 billion by 2030. In the short term, it is expected to reduce anxiety in solid tumor patients undergoing radiotherapy, leading to lower appointment cancellation rates and maximized treatment compliance, resulting in tangible cost savings. Compared to conventional benzodiazepine therapies, it has no risk of addiction or side effects, making it highly suitable for cancer patients undergoing multi-drug regimens and offering a clear competitive advantage in terms of safety. In the medium to long term, it has the potential to create new business opportunities in conjunction with the growth of the digital psychotherapeutics market, including cognitive behavioral therapy and virtual reality-based mental health devices. If clinical efficacy is demonstrated in the future, it will be a significant milestone in its official entry into standard radiotherapy protocols and multinational healthcare insurance reimbursement systems.

Source: ClinicalTrials.gov (api_ct)

https://clinicaltrials.gov/study/NCT04513444