Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics (Leucosteo)

December 16, 2022 updated by: Assistance Publique - Hôpitaux de Paris

During the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient.

Osteopathy is an exclusively manual practice whose goal is to compensate for mobility dysfunctions of the tissues of the human body. It can be used as a complementary treatment for cancer pain when pain medications are not enough.

The aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia.

Study Overview

Status

Not yet recruiting

Conditions

Lymphoblastic Leukemia

Intervention / Treatment

Other: osteopathy

Detailed Description

During the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient.

The aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia.

Primary objective :

To evaluate the effectiveness of five osteopathy sessions at regular intervals on the characteristics of the pain felt in patients aged 1 to 10 years treated for acute lymphoblastic leukemia using the HEDEN scale (Hetero-Evaluation Pain Child).

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Benoit BRETHON, MD
Phone Number: +33171282536
Email: benoit.brethon@aphp.fr

Study Contact Backup

Name: Laurent STUBBE, MD
Phone Number: +33164614870
Email: laurent.stubbe@eso-suposteo.fr

Study Locations

France
- - Paris, France, 75019
    - Robert Debre Hospital
    - Contact:
      
      Benoit BRETHON, MD
      
      Phone Number: +33171282536
      
      Email: benoit.brethon@aphp.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute lymphoblastic leukemia

Description

Inclusion Criteria:

Patient managed and treated with a diagnosis of acute lymphoblastic leukemia
Patient between 1 and 10 years of age
Patient with pain at inclusion, or pain at diagnosis related to leukemia
Social security affiliation or entitlement
Signature of informed consent by both parents

Exclusion Criteria:

No pain reported at the time of management or diagnosis
Surgery less than 30 days old
Patient with another contraindication to osteopathic treatment (worsening of the condition, bleeding syndrome), or a psychiatric pathology that prevents the scales from being used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of 5 weekly osteopathy sessions at regular intervals from week 1 to week 5 on the characteristics of the pain felt in patients aged 1 to 10 years treated for acute lymphoblastic leukemia using the HEDEN scale. Time Frame: 5 weeks	HEDEN (Hetero-Evaluation Pain Child) score before and after each intervention	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of 5 weekly osteopathy sessions at regular intervals from week 1 to week 5 on the intensity of the pain felt in patients aged 4 to 10 years treated for acute lymphoblastic leukemia using the face scale: FPS -R. Time Frame: 5 weeks	FPS-R (Face Pain Scale-Revised) score before and after each osteopathy session	5 weeks
To study the variations in quality of life at inclusion and at the end of the study using the PedsQL™ (questionnaire quality of life in paediatrics). Time Frame: 5 weeks	PedsQL™ Questionnaire quality of life in paediatrics	5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Benoit BRETHON, MD, Assistant publique Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Estimate)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)