An interventional study of HYPNOSIS in Sarcoma, Germ Cell Tumor of Testis and Ovarian Tumor, sponsored by Institut Bergonié. Recruiting at 1 site in France. Open to participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Institut Bergonié · Not applicable, Interventional, and Supportive care
The HYPNO-AJA 2 study is a prospective single-center interventional clinical trial conducted at the Institut Bergonié to evaluate the effectiveness of hypnosis in reducing anxiety and chemotherapy-related symptoms in adolescents, young adults (AYAs), and young women undergoing cancer treatment. The study focuses on patients aged 15-39 with sarcoma or germ cell tumors and women aged 15-49 with breast cancer receiving neoadjuvant chemotherapy.
Cancer treatment in AYAs is frequently associated with high levels of psychological distress, particularly anxiety related to chemotherapy sessions, invasive procedures, and repeated hospitalizations. Previous studies suggest that hypnosis may help reduce anxiety, pain, nausea, and emotional distress in oncology patients, but evidence remains limited in AYA populations and specific cancer types such as sarcoma, germ cell tumors, and breast cancer. HYPNO-AJA 2 aims to address this gap by assessing the feasibility, safety, and therapeutic value of hypnosis during chemotherapy.
The study's primary objective is to determine whether hypnosis can significantly reduce anxiety symptoms during chemotherapy. Secondary objectives include evaluating its effects on nausea and vomiting, pain, medication consumption (anxiolytics and antiemetics), quality of life, body image perception, and patient satisfaction.
The trial will include 70 participants divided into two cohorts:
Eligible participants must be newly diagnosed, treated at Institut Bergonié, and receiving chemotherapy based on anthracyclines and/or alkylating agents. Patients with contraindications to hypnosis, severe psychiatric or cognitive disorders, recent hypnosis exposure, or inability to comply with follow-up procedures are excluded.
The intervention consists of a hypnosis session performed during the second chemotherapy cycle by a specialized oncology nurse trained in Ericksonian hypnosis and pain management. Sessions will last between 30 and 60 minutes and take place in a private and comfortable environment. The hypnosis procedure includes a preparatory discussion, hypnotic induction, progressive return to normal consciousness, and debriefing adapted to the patient's needs.
Anxiety levels will be assessed using a Visual Analog Scale (VAS-Anxiety) before and after chemotherapy cycles 1, 2, and 3. Cycle 2 includes hypnosis, whereas cycles 1 and 3 do not. The primary endpoint is the difference in anxiety levels after cycle 2 compared with cycle 3. Secondary outcomes will evaluate chemotherapy-induced nausea and vomiting using the PRO-CTCAE system, pain intensity, medication use, quality of life through the EORTC QLQ-C30 questionnaire, body image changes using the Body Image Scale, and satisfaction with hypnosis sessions.
The planned enrollment period is 18 months, with a total study duration of 24 months and individual patient participation lasting approximately six months. Statistical analyses will compare anxiety scores after chemotherapy with and without hypnosis using paired statistical tests. Based on preliminary results from the earlier HYPNO-AJA-1 pilot study, the sample size is expected to provide more than 90% statistical power to detect clinically meaningful reductions in anxiety.
The investigators expect hypnosis to improve patients' psychological well-being, reduce symptom burden and medication use, enhance quality of life and body image acceptance, and strengthen the therapeutic relationship between patients and caregivers. More broadly, the study may support the integration of hypnosis into supportive oncology care pathways as a low-cost, non-pharmacological intervention adapted to young cancer patients.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
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Newly diagnosed patients receiving initial care and follow-up at the Institut Bergonié during treatment:
Treatment administered as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: HYPNOSIS
Hypnosis session will be performed at chemotherapy cycle 2
Efficacy of hypnosis in terms of presence of reduction of anxiety disorders
The presence of anxiety disorders will be assessed using a visual analog scale (VAS), a 10-cm line ranging from 0 (no anxiety) to 10 (extreme anxiety). We will report the difference between the mean VAS score after a chemotherpy session without hypnosis (chemotherapy cycle 3) and the mean VAS score after a chemotherapy session with hypnosis (chemotherapy cycle 2).
Time frame: 3 months
Efficacy of hypnosis in terms of reduction of nausea
The presence of chemotherapy-induced nausea will be assessed at each treatment cycle using the NCI's PRO-CTCAE® (Patient-Reported Outcomes Common Terminology Criteria for Adverse Events) measurement system. We will rely on the item dedicated to the frequency : "How often did you have nausea in the past 7 days?" (Response options: Never / Rarely / Occasionally / Frequently / Almost constantly). We will report the number of patients who present a frequency of nausea after a chemotherapy session with hypnosis (chemotherapy cycle 2) lower than the frequency of nausea reported after chemotherapy session without hypnosis (chemotherapy cycle 3).
Time frame: 3 months
Efficacy of hypnosis in terms of reduction of vomiting
The presence of chemotherapy-induced vomiting will be assessed at each treatment cycle using the NCI's PRO-CTCAE® (Patient-Reported Outcomes Common Terminology Criteria for Adverse Events) measurement system. We will rely on the item dedicated to the frequency : "How often did you have vomiting in the past 7 days?" (Response options: Never / Rarely / Occasionally / Frequently / Almost constantly). We will report the number of patients who present a frequency of vomiting after a chemotherapy session with hypnosis (chemotherapy cycle 2) lower than the frequency of vomiting reported after chemotherapy session without hypnosis (chemotherapy cycle 3).
Time frame: 3 months
Efficacy of hypnosis in terms of reduction of pain
The presence of pain will be assessed using a visual analog scale (VAS). We will report the difference between the mean VAS score after a chemotherapy session without hypnosis (chemotherapy cycle 3) and the mean VAS score after a chemotherapy session with hypnosis (chemotherapy cycle 2).
Time frame: 3 months
Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
Of 144 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 21 months is below that.
Counting every sponsor, half of 147 studies reached it within 59 months; a quarter within 34 and three quarters within 120.
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