Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

All Drugs and Chemicals

Sympathomimetics

Measurement of the modification of the sympathomimetic balance

Holter ECG

Lifestyle questionary (time spent in front of television, physical activity)

Questionary

Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.

Pupillometry

EVE HUART, MD

Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.

The sympathomimetic balance was measured using a Holter-ECG heart rate monitor. The parameters collected were used to calculate the variability of the heart rate, the high frequencies (HF, reflection of the parasympathetic system), the low frequencies (LF, reflection of the sympathetic system and the parasympathetic system) and the ratio // LF / HF (reflection of the sympathetic activity) thanks to Fourier analysis and the use of HRVanalysis software.

The measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between D7 and D10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative.

The measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system.

A baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. This measure was renewed at 3 months.

A measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months.

A Respiratory Functional Exploration associated with a stress test with calculation of the VO2max is systematically carried out before the esophageal surgery. A Respiratory Functional Exploration was renewed 4 to 8 weeks after the intervention, and then at 3 months. the 6-minute walk test was performed at the same time.

Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery

Day 0 = surgery measured with the Holter Electrocardiogram

baroreflex sensitivity : ms/mmHg Day 0 = surgery

Peak expiratory volume per second : L Day 0 = surgery

walking distance in 6 minutes Day 0 = surgery

Centre Hospitalier Universitaire de Saint Etienne

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Emmanuelle GA JACQUET

Anne Stoeckle

Emmanuelle JACQUET

Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity.

Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery.

The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment).

To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients.

The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)

Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to 2019, for a localized breast cancer, will be identified be Cristal Link software.

A questionary, including every studied variables and potential confounding factors, will be sent, by post or by e mail, to the patients. An information notice and a non opposition formulary will be joined to the questionary.

Patients will be contacted by a paramedical member of the Women Cancer Center of the University Hospital, in order to explain them the objective of the study, and the modality of personal data management.

The questionary will be returned either by mail, or directly brought back to the Hospital along a medical appointment.

Data collection will focus on return to work delay, return to work modality (part or full time, redeployment), studied variables and potential confounding factors (demographic : marital status, number of dependent children, incomes / related to occupational activity : night work, job responsibility, occupational physician follow up / treatment consequences : OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support measures : physical activities, psychological support, alternative therapeutics, familial support, medical staff support).

Medical data (tumour features : histology, extent, treatment : surgery, chemiotherapy, targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.

Subjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary / Support : Multidimensional Scale of Support).

Data process will be done in the Clinical Investigation Center of Grenoble University Hospital.

ACTIVPROSEIN : Professional Activity After Breast Cancer

Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study

Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables

Assessment of delay of full time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables

Assessment of delay of part time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables

Assessment of delay of occupational reclassification, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer	NCT04835987	Esophageal Canc...	Holter ECG Questionary Pupillometry	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer	NCT04835987	Esophageal Canc...	Holter ECG Questionary Pupillometry	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
ACTIVPROSEIN : Professional Activity After Breast Cancer	NCT06025604	Breast Cancer F... Return to Work		18 Years - 60 Years	University Hospital, Grenoble
ACTIVPROSEIN : Professional Activity After Breast Cancer	NCT06025604	Breast Cancer F... Return to Work		18 Years - 60 Years	University Hospital, Grenoble

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Every month we try and update this database with for questionary cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for questionary

Every month we try and update this database with for questionary cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for questionary cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.