NCT03508180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

March 5, 2018

Last Update Submit

December 13, 2025

Conditions

Lung Cancer and Cancer of Digestive System

Keywords

Supportive carecancerfoot reflexologynauseavomiting

Outcome Measures

Primary Outcomes (1)

  • 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

    6 hours

Secondary Outcomes (4)

  • 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.

  • Quality of life

    Between day 0 and day 78

  • Anxiety

    Between day 0 and day 78

  • Body image

    Day 0

Study Arms (2)

foot reflexology

EXPERIMENTAL

patients WITH foot reflexology session during chemotherapy treatments

Behavioral: INTERVIONNAL

platinum-based treatment

PLACEBO COMPARATOR

Patients WITHOUT ANY foot reflexology session during chemotherapy treatments

Other: CONTROL

Interventions

INTERVIONNALBEHAVIORAL

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.

foot reflexology
CONTROLOTHER

None intervention.

platinum-based treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Related Publications (2)

  • 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.

    PMID: 32449505RESULT

  • 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.

    PMID: 34738909RESULT

MeSH Terms

Conditions

Lung NeoplasmsDigestive System NeoplasmsNeoplasmsNauseaVomiting

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre-Jean SOUQUET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

April 25, 2018

Study Start

June 14, 2018

Primary Completion

February 3, 2020

Study Completion

April 8, 2020

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)