REFYO-R: Benefit Evaluation of Foot Reflexology in Oncology

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03508180
Collaborator
(none)
80
1
2
21.8
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: INTERVIONNAL
  • Other: CONTROL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
Actual Study Start Date :
Jun 14, 2018
Actual Primary Completion Date :
Feb 3, 2020
Actual Study Completion Date :
Apr 8, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Lyon Sud Pierre-Bénite France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03508180
Other Study ID Numbers:
  • 69HCL17_0676
First Posted:
Apr 25, 2018
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2021