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Completed

NCT Number: NCT03508180

Benefit Evaluation of Foot Reflexology in Oncology

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.

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Key information

Conditions

Lung Cancer and Cancer of Digestive System Digestive System Diseases Digestive System Neoplasms Lung Diseases Lung Neoplasms Nausea Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Thoracic Neoplasms Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTERVIONNAL

Behavioral

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.

Control

Other

None intervention.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: REFYO-R

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2018
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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