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

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.

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.

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): 15

Contacts and Locations

• 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

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• 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

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.	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.	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).	PedsQL™ Questionnaire quality of life in paediatrics	5 weeks

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Benoit BRETHON, MD, Assistant publique Hopitaux de Paris

Study record dates

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): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: osteopathy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: APHP220699; IDRCB: 2022-A01261-42 (Registry Identifier: French Health Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No