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

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ClinicalTrials.gov Identifier: NCT03508180
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Lung Cancer and Cancer of Digestive System Behavioral: INTERVIONNAL Other: CONTROL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 14, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508180


Contacts
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Contact: Pierre-Jean SOUQUET, MD 04 78 86 44 00 ext +33 pierre-jean.souquet@chu-lyon.fr

Locations
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France
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Pierre-Jean SOUQUET, MD    04 78 86 44 00 ext +33    pierre-jean.souquet@chu-lyon.fr   
Principal Investigator: Pierre-Jean SOUQUET, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre-Jean SOUQUET, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03508180     History of Changes
Other Study ID Numbers: 69HCL17_0676
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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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:
Supportive care
cancer
foot reflexology
nausea
vomiting
Additional relevant MeSH terms:
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Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases