Algology in Oncology Osteopathic Support (ALGOS)

Breast Cancer Clinical Trial

— ALGOS  

Official title:

Algology in Oncology Osteopathic Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726929
• Other study ID #: RCB: 2022-A01349-34
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 8, 2024

Study information

• Verified date: February 2023
• Source: Institut Toulousain d'Ostéopathie
• Contact: Marie Bourguoin, MD
• Phone: +33531155753
• Email: bourgouin.marie[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 8, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Osteopathic treatment
Osteopathic Manual Treatment
• Capsaicin QUTENZA Patch (TAU)
Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service

Locations

Country	Name	City	State
France	Institut Claudius Regaud Toulouse Oncopole	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Toulousain d'Ostéopathie	Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Working Alliance Inventory	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	10 minutes / evaluation at the end of Osteopathic consultation n°2 at 1.5 month.
Primary	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	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
Secondary	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.