Algology in Oncology Osteopathic Support (ALGOS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Algology in Oncology Osteopathic Support

Conditions
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Breast Cancer, Neuropathic Pain

Intervention / Treatment
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* Other: Osteopathic treatment
* Other: Capsaicin QUTENZA Patch (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic treatment (OT)<br>Osteopathic treatment, 3 sessions of 1h + Treatment As Usual (TAU) | Other: Osteopathic treatment<br>* Osteopathic Manual Treatment<br>Other: Capsaicin QUTENZA Patch (TAU)<br>* Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service<br>|
| Active Comparator: Treatment As Usual (TAU)<br>Treatment As Usual, Capsaicin Qutenza Patch (Conventionnal Treatment in algology in supportive care) | Other: Capsaicin QUTENZA Patch (TAU)<br>* Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive care, Osteopathy