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Algology in Oncology Osteopathic Support (ALGOS) (ALGOS)

Primary Purpose

Breast Cancer, Neuropathic Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic treatment
Capsaicin QUTENZA Patch (TAU)
Sponsored by
Institut Toulousain d'Ostéopathie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Supportive care, Osteopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Institut Claudius Regaud Toulouse OncopoleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osteopathic treatment (OT)

Treatment As Usual (TAU)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Brief Pain Inventory from baseline to 9 months
Impact of pain in the quality of life (Brief Pain Inventory Score) / 9 questions with scales 0 to 10, where 0 = No pain and 10 = Maximal pain or impact
Changes in Viscoelastic Scar Tissue Properties from baseline to 9 months
Mechanical Fascial tissue properties evaluated by MyotonPRO device (Validity/reliability confirmed in scientific research). This is a Non invasive device. A standardized force ( 0.48N) applied on the superficial skin to study the mechanical oscillation in response of the deformation. Variables measured are the Tone (Hz), Stiffness (N/m), Logaryhmic decrement, Relaxation time (ms). All these parameters traduce the "state of tone -elasticity" of the fascial tissue. (Higher is the stiffness value higher is the state of tone. Lower is the value lower is the tension).

Full Information

First Posted
January 12, 2023
Last Updated
February 3, 2023
Sponsor
Institut Toulousain d'Ostéopathie
Collaborators
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT05726929
Brief Title
Algology in Oncology Osteopathic Support (ALGOS)
Acronym
ALGOS
Official Title
Algology in Oncology Osteopathic Support
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
December 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Toulousain d'Ostéopathie
Collaborators
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Background: In women, the breast is the most common cancer site in the world and is unfortunately the one with the highest number of deaths. It is estimated that 30-50% of women who have undergone a mastectomy are affected by this post-operative syndrome and that 50% of patients would report chronic pain one year after surgery. Chronic pain after breast surgery (incidence of 30% at 3 months) has an essentially neuropathic component. There are many contributing factors, depending on the surgery, the patient, the analgesia technique and the treatments associated with the cancer. Methods: The ALGOS study has received a favourable opinion from the Ethical Committee (CPP). Capsaicin patch (Qutenza 179mg) treatment as usual (TAU) is delivered in medical algological care in Oncopole, Toulouse, France. In total 120 patients meeting the inclusion criteria will be randomly assigned to one of the 3 treatment groups: One receiving osteopathic treatment before the TAU (Group 1) ; The second group receiving the OT in addition to and during the TAU (Group 2) ; The third group will receive OT after the TAU and if considered in "therapeutic failure" (Group 3). Each group will have his own control (G1C-G2C-G3C). All the patients in group 1,2,3 will receive 3 1-hour osteopathic treatment sessions in a "backbox" strategy of treatment. The TAU by Qutenza is defined and recommended by the French health high authority. The primary outcome is the evaluation of neuropathic pain by DN4 score. The secondary outcomes include superficial fascial tissue properties of the scar by MyotonPRO, the therapeutic alliance quality will be evaluated by the Working Alliance Inventory (WAI) and the impact of pain in their quality of life by the Brief Pain Inventory (BPI score). Discussion: If the results of the ALGOS study are positive, the study will provide arguments in favor of osteopathic treatment as a possible non-invasive additional treatment option in the multidisciplinary care support approach for patients with neuropathic pain after a breast cancer. Trial Registration: Date: Release December-09, 2022 (positive opinion from ethical committee CPP) /N° ID-RCB: 2022-A01349-34.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neuropathic Pain
Keywords
Supportive care, Osteopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic treatment (OT)
Arm Type
Experimental
Arm Description
Osteopathic treatment, 3 sessions of 1h + Treatment As Usual (TAU)
Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment As Usual, Capsaicin Qutenza Patch (Conventionnal Treatment in algology in supportive care)
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
Osteopathic Manual Treatment
Intervention Type
Other
Intervention Name(s)
Capsaicin QUTENZA Patch (TAU)
Intervention Description
Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service
Primary Outcome Measure Information:
Title
Changes in Neuropathic pain assessment from baseline to 9 months
Description
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
Time Frame
5 minutes of test / Day 0 (inclusion) / every 3 months / at the end of the study 9 months after inclusion
Secondary Outcome Measure Information:
Title
Changes in Brief Pain Inventory from baseline to 9 months
Description
Impact of pain in the quality of life (Brief Pain Inventory Score) / 9 questions with scales 0 to 10, where 0 = No pain and 10 = Maximal pain or impact
Time Frame
10 minutes / Evaluation Every 3 months and at the end of the study after 9 months
Title
Changes in Viscoelastic Scar Tissue Properties from baseline to 9 months
Description
Mechanical Fascial tissue properties evaluated by MyotonPRO device (Validity/reliability confirmed in scientific research). This is a Non invasive device. A standardized force ( 0.48N) applied on the superficial skin to study the mechanical oscillation in response of the deformation. Variables measured are the Tone (Hz), Stiffness (N/m), Logaryhmic decrement, Relaxation time (ms). All these parameters traduce the "state of tone -elasticity" of the fascial tissue. (Higher is the stiffness value higher is the state of tone. Lower is the value lower is the tension).
Time Frame
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 Pre-specified Outcome Measures:
Title
Working Alliance Inventory
Description
Score to evaluate the quality of therapeutic alliance / 36 questions each item is scored from 1 (minimum) to 7 (maximum) / Global score on 252 / Higher scores reflects a more positive rating of working alliance
Time Frame
10 minutes / evaluation at the end of Osteopathic consultation n°2 at 1.5 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Bourguoin, MD
Phone
+33531155753
Email
bourgouin.marie@iuct-oncopole.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc TREFFEL, PhD
Organizational Affiliation
Institut Toulousain d'Ostéopathie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Claudius Regaud Toulouse Oncopole
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bourguoin, MD
Phone
+33531155753
Email
bourgouin.marie@iuct-oncopole.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Algology in Oncology Osteopathic Support (ALGOS)

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