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

Civil Hospices of Lyon logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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