Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Anxiety Disorders

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Patients coming for preoperative breast assessment will have standard care.

standard care

Patients coming for preoperative breast assessment will have standard care with conversational hypnosis

standard care + conversational hypnosis

HENROT Philippe, MD

The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.

The pain level will be assessed in each group by a visual analog scale from 0 to 10.

The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.

assessment realisation time flet by patient

The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.

Institut de Cancérologie de Lorraine

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Anticoagulants

Other Dietary Supplements

Tamoxifen

Citric Acid

Sodium Citrate

Fenretinide

Retinamide

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Protective Agents

Citrate

Tamoxifen + Fenretinide daily for 14-28 days

Tamoxifen Citrate

Placebo

Sonja E. Singletary, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide and tamoxifen before surgery may be an effective way to prevent the recurrence of or further development of breast cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer.

OBJECTIVES: I. Determine the feasibility of identifying surrogate endpoint biomarkers in women with breast ductal carcinoma in situ and associated neoplastic and preneoplastic lesions. II. Determine whether treatment with fenretinide and tamoxifen administered daily will cause significant modulation of proposed surrogate endpoint biomarkers in this patient population.

OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to histological diagnosis (hyperplasia vs carcinoma). All patients undergo a core biopsy and fine needle aspiration of the index lesion and are then assigned randomly to a treatment arm. Arm I receives tamoxifen and fenretinide daily. Arm II receives a placebo daily. Both arms continue for 14-28 days, until definitive surgery or a second biopsy is performed.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study, 50 patients per arm.

Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer

Phase II Clinical Trial of N-(4-hydroxyphenyl) Retinamide (4-HPR) and Tamoxifen in Breast Neoplasia, Administration During the Period Between the Diagnostic Core Biopsy and Definitive Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer	NCT02867644	Breast Cancer	standard care standard care +...	18 Years -	Institut de Cancérologie de Lorraine
Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer	NCT02867644	Breast Cancer	standard care standard care +...	18 Years -	Institut de Cancérologie de Lorraine
Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer	NCT00003099	Breast Cancer	Fenretinide Tamoxifen Citra... Placebo	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for breast neoplasia