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

Primary Purpose

Lung Cancer and Cancer of Digestive System

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
INTERVIONNAL
CONTROL
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer and Cancer of Digestive System focused on measuring Supportive care, cancer, foot reflexology, nausea, vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

foot reflexology

platinum-based treatment

Arm Description

patients WITH foot reflexology session during chemotherapy treatments

Patients WITHOUT ANY foot reflexology session during chemotherapy treatments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nausea and vomiting between each chemotherapy
Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.
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.
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
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

Full Information

First Posted
March 5, 2018
Last Updated
May 27, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03508180
Brief Title
Benefit Evaluation of Foot Reflexology in Oncology
Acronym
REFYO-R
Official Title
Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer and Cancer of Digestive System
Keywords
Supportive care, cancer, foot reflexology, nausea, vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
foot reflexology
Arm Type
Experimental
Arm Description
patients WITH foot reflexology session during chemotherapy treatments
Arm Title
platinum-based treatment
Arm Type
Placebo Comparator
Arm Description
Patients WITHOUT ANY foot reflexology session during chemotherapy treatments
Intervention Type
Behavioral
Intervention Name(s)
INTERVIONNAL
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CONTROL
Intervention Description
None intervention.
Primary Outcome Measure Information:
Title
Evaluation of nausea and vomiting
Description
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
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Nausea and vomiting between each chemotherapy
Description
Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.
Time Frame
Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.
Title
Quality of life
Description
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.
Time Frame
Between day 0 and day 78
Title
Anxiety
Description
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
Time Frame
Between day 0 and day 78
Title
Body image
Description
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
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Jean SOUQUET, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34738909
Citation
Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.
Results Reference
derived
PubMed Identifier
32449505
Citation
Murat-Ringot A, Souquet PJ, Chauvenet M, Rentler C, Subtil F, Schott AM, Preau M, Piriou V. The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17232. doi: 10.2196/17232.
Results Reference
derived

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Benefit Evaluation of Foot Reflexology in Oncology

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