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Completed

NCT Number: NCT03250130

Hypnosis for Patients Treated With Adjuvant Chemotherapy for Breast Cancer(HYPNOVAL)

The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut régional du Cancer de montpellier

Montpellier, 34298, France

About this study

In the field of management of cancer, many approaches have been used since tens of years, particularly in regard of pain management, both in achieving surgical or invasive procedures in the pain induced by the disease itself. the investigators owe the first description in 1829 Chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy should be performed. Meta-analysis (2000) showed the positive impact of analgesia obtained through hypnosis on the perception of pain intensity. In children in whom regular venous punctures is performed, using hypnosis seems indisputable on the management of anticipatory anxiety, leading to a better experience of the act itself. Regarding the nausea and vomiting induced by chemotherapy, numerous studies are old, not always randomized and performed often before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting, the updated studies should emerge on the issue of delayed emesis which remain a serious adverse event and not completely resolved. Mark to improve the EORTC validated tools of quality of life measurement widely used for example in ovarian cancer.

The impact of hypnosis on the quality of life or the side effects of treatment or rehospitalization for toxicity remains controversial (Judson, 2011). A meta-analysis combining the tests carried out before and after the era of setrons (Richardson, 2007) concluded that the effectiveness of the anticipated nausea and vomiting.

In this context,the investigators proposed to conduct a feasibility study to evaluate the role and impact of medical Ericksonian hypnosis on acute and delayed adverse event (incl nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer.

The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Female, age > 18 years-old
  • Without previous practice of hypnosis
  • Patient with diagnosis of breast cancer
  • Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy
  • Patient accepting the principle of the study with a signed written informed consent
  • Patient affiliated to French Social Security

Exclusion criteria

  • • Male
  • Age < 18 years
  • Patient refusing hypnosis
  • Pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential.
  • Patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics)
  • Not ability to speak and read French, deaf and/or mute

Treatment and study plan

hypnosis

Behavioral

The patient achieve self-hypnosis sessions in these chemotherapy treatments

Primary outcomes

  1. proportion of patients rated as being compliant to self-hypnosis

    Time frame: through study completion, an average of 2 years

    The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy.

    Primary endpoint is the proportion of patients rated as being compliant to self-hypnosis sessions during adjuvant chemotherapy (6 sessions). A patient is considered as compliant if it achieves at least 2/3 of the planned self-hypnosis sessions, that is, 4 of 6 planned sessions.

Secondary outcomes

  1. Impact of hypnosis on the tolerance of the CT

    Time frame: through study completion, an average of 2 years

    The secondary objective is to describe its impact on the tolerance of the CT

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Medical Ericksonian Hypnosis on Patients Treated With Adjuvant Chemotherapy for Breast Cancer at the ICM Val d'Aurelle - Montpellier: a Feasibility Study

Acronym: HYPNOVAL

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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