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| Name | Class |
|---|---|
| Institut de Formation en Ostéopathie du Grand Avignon | UNKNOWN |
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In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.
Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.
This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients will receive only caner treatment. No osteopathic treatment. |
|
| Osteopathic intervention | Experimental | Patients will receive cancer treatment associated with osteopathic intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic intervention | Other | Nerve vagus stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment | To assess the effect of vagus nerve osteopathic stimulations on Heart Rate Variability | up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of C-Reactive Protein | To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory | up to 84 days |
| Time to definitive improvement in global health status / QoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Borhane SLAMA, MD | Centre Hospitalier Henri Duffaut - Avignon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Henri Duffaut | Avignon | 84000 | France |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
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| CRP assessment |
| Biological |
Blood CRP will be assessed during trial |
|
| QLQ-C30 questionnaire | Behavioral | Completion of QLQ-C30 |
|
To assess the effect of vagus nerve osteopathic stimulations on health related quality of life
| up to 84 days |
| D012140 |
| Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |