Benefit Evaluation of Foot Reflexology in Oncology

Not Applicable

Completed

• Conditions: Lung Cancer and Cancer of Digestive System
• Interventions: Behavioral: INTERVIONNAL; Other: CONTROL

• Registration Number: NCT03508180
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Study Start: 2018-06-14
• Primary Completion: 2020-02-03
• Study Completion: 2020-04-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
foot reflexology	INTERVIONNAL	patients WITH foot reflexology session during chemotherapy treatments
platinum-based treatment	CONTROL	Patients WITHOUT ANY foot reflexology session during chemotherapy treatments

Primary Outcome Measures

Name	Time	Method
Evaluation of nausea and vomiting	6 hours	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

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting between each chemotherapy	Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.	Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.
Quality of life	Between day 0 and day 78	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.
Anxiety	Between day 0 and day 78	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
Body image	Day 0	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

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France