NCT05726929

Brief Summary

The aim of the study is to evaluate the Impact of add-on osteopathic treatment in the algological course of patients treated for breast cancer : Randomized Controlled Trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 11, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

January 12, 2023

Last Update Submit

February 14, 2025

Conditions

Breast CancerNeuropathic Pain

Keywords

Supportive careOsteopathy

Outcome Measures

Primary Outcomes (1)

  • Changes in Neuropathic pain assessment from baseline to 9 months

    Neuropathic pain assessment in 4 points (DN4 questionnaire) 10 questions / A result more than 4/10 means a neuropathic pain component. 0 = minimum 10 = maximum

    5 minutes of test / Day 0 (inclusion) / every 3 months / at the end of the study 9 months after inclusion

Secondary Outcomes (2)

  • Changes in Brief Pain Inventory from baseline to 9 months

    10 minutes / Evaluation Every 3 months and at the end of the study after 9 months

  • Changes in Viscoelastic Scar Tissue Properties from baseline to 9 months

    5 minutes of measurements / Day 0 at inclusion and at each Osteopathic session every 15days (3 sessions) and at the end of the study 9 months after inclusion.

Other Outcomes (1)

  • Working Alliance Inventory

    10 minutes / evaluation at the end of Osteopathic consultation n°2 at 1.5 month.

Study Arms (2)

Osteopathic treatment (OT)

EXPERIMENTAL

Osteopathic treatment, 3 sessions of 1h + Treatment As Usual (TAU)

Other: Osteopathic treatmentOther: Capsaicin QUTENZA Patch (TAU)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Treatment As Usual, Capsaicin Qutenza Patch (Conventionnal Treatment in algology in supportive care)

Other: Capsaicin QUTENZA Patch (TAU)

Interventions

Osteopathic treatmentOTHER

Osteopathic Manual Treatment

Osteopathic treatment (OT)
Capsaicin QUTENZA Patch (TAU)OTHER

Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service

Osteopathic treatment (OT)Treatment As Usual (TAU)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major patients with sequelae of pain following breast cancer surgery with or without other treatments and who have been in pain for more than 3 months. Neuropathic pain may be experienced in the upper and middle chest, armpit and/or arm ipsilateral to the surgery and/or radiotherapy.

You may not qualify if:

  • Unemancipated minors, protected adults and adults who are not in a position to give their consent are excluded from the protocol.
  • Patients who do not have social security coverage
  • Patients with non-iatrogenic peripheral neuropathy
  • Patients who do not speak French
  • Patients with confusional disorders
  • Patients with a brain tumour
  • Any patient with healing disorders at the surgical site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Claudius Regaud Toulouse Oncopole

Toulouse, 31100, France

Location

MeSH Terms

Conditions

Breast NeoplasmsNeuralgia

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Loïc TREFFEL, PhD

    Institut Toulousain d'Ostéopathie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 14, 2023

Study Start

January 11, 2023

Primary Completion

December 8, 2024

Study Completion

December 8, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

FR(1)