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Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| foot reflexology | Experimental | patients WITH foot reflexology session during chemotherapy treatments |
|
| platinum-based treatment | Placebo Comparator | Patients WITHOUT ANY foot reflexology session during chemotherapy treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTERVIONNAL | Behavioral | Foot reflexology session (30 minutes) each course of chemotherapy (total 4 courses) during the 4 hours following the first 2 hours of injection + auto-massage done by the patient between each course. During a session focused on the treatment of nausea / vomiting, the reflexologist will stimulate the reflex zones related to the digestive system in order to calm and stimulate all areas for deep relaxation of the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of nausea and vomiting | The relative change in VAS* associated with nausea and vomiting will be evaluated between T1 (measured at least 2 hours after the start of chemotherapy injection) and T2 (measured at least 6 hours after the start of injection of the drug chemotherapy). *VAS : from 0 to 10 ; 0 is no nausea or vomiting and 10 is insufferable nausea or vomiting | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and vomiting between each chemotherapy | Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook. | Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63. |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Jean SOUQUET, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32449505 | Result | Murat-Ringot A, Souquet PJ, Chauvenet M, Rentler C, Subtil F, Schott AM, Preau M, Piriou V. The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17232. doi: 10.2196/17232. | |
| 34738909 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009369 | Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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|
| CONTROL | Other | None intervention. |
|
Relative variation of the EORTC QLQC 30* (European Organisation for Research and Treatment of Cancer) between the inclusion visit (V2) and the end-of-study visit (V6).
*EORTC QLQ C30 : All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
| Between day 0 and day 78 |
| Anxiety | Relative variation of the HADS* (Hospital and Anxiety Depression Scale) anxiety score between the inclusion visit (V2) and the end-of-study visit (V6). *HADS : 0 to 21, the highest scores corresponding to the presence of a more severe symptomatology | Between day 0 and day 78 |
| Body image | Evaluation of the body image to the end-of-study visit by the Body Image Questionnaire* (BIC), which measures the body image at a given moment t. The analysis will take into account the self-esteem assessed upon the inclusion visit on the Rosenberg scale** (V2). *BIC : The total score is between 19 and 95. **Rosenberg Scale : The total score ranges from 10 to 40. A score below 31 is considered low self-esteem | Day 0 |
| Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648. |
| D012140 |
| Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |