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

May 27, 2021 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: foot reflexology
patients WITH foot reflexology session during chemotherapy treatments
Behavioral: INTERVIONNAL

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.
Placebo Comparator: platinum-based treatment
Patients WITHOUT ANY foot reflexology session during chemotherapy treatments
Other: CONTROL
None intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of nausea and vomiting
Time Frame: 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
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea and vomiting between each chemotherapy
Time Frame: 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.
Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.
Quality of life
Time Frame: 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.
Between day 0 and day 78
Anxiety
Time Frame: 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
Between day 0 and day 78
Body image
Time Frame: 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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pierre-Jean SOUQUET, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

February 3, 2020

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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