Benefit Evaluation of Foot Reflexology in Oncology

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy

Conditions
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Lung Cancer and Cancer of Digestive System

Intervention / Treatment
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* Behavioral: INTERVIONNAL
* Other: CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy Good performance status of (ECOG 0-2) More than 18 years old Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises. Patient affiliated to Social Security or equivalent Informed consent signed Exclusion Criteria: Phlebitis Cellar syndrome Weight loss> 5% in 3 months Uncontrolled pain Patients under morphine and derivatives Brain metastases Patient benefiting from foot reflexology outside the study Patient under guardianship or curatorship or deprived of his rights

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: foot reflexology<br>patients WITH foot reflexology session during chemotherapy treatments | Behavioral: INTERVIONNAL<br>* 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.<br>|
| Placebo Comparator: platinum-based treatment<br>Patients WITHOUT ANY foot reflexology session during chemotherapy treatments | Other: CONTROL<br>* None intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive care, cancer, foot reflexology, nausea, vomiting