Benefit Evaluation of Foot Reflexology in Oncology (REFYO-R)

Civil Hospices of Lyon

Status: Completed

Conditions: Lung Cancer and Cancer of Digestive System

Treatments: Behavioral: INTERVIONNAL; Other: CONTROL

Study type: Interventional

Funder types: Other

Identifiers

NCT03508180

69HCL17_0676

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

foot reflexology

Experimental group

Description:

patients WITH foot reflexology session during chemotherapy treatments

Treatment:

Behavioral: INTERVIONNAL

platinum-based treatment

Placebo Comparator group

Description:

Patients WITHOUT ANY foot reflexology session during chemotherapy treatments

Treatment:

Other: CONTROL