Algology in Oncology Osteopathic Support (ALGOS)

NCT ID: NCT05726929

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2024-12-08

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.

Conditions

Breast Cancer; Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Osteopathic treatment (OT)

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

Group Type: EXPERIMENTAL

Osteopathic treatment

Intervention Type: OTHER

Osteopathic Manual Treatment

Capsaicin QUTENZA Patch (TAU)

Intervention Type: OTHER

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

Treatment As Usual (TAU)

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

Group Type: ACTIVE_COMPARATOR

Capsaicin QUTENZA Patch (TAU)

Intervention Type: OTHER

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

Interventions

Osteopathic treatment

Osteopathic Manual Treatment

Intervention Type: OTHER

Capsaicin QUTENZA Patch (TAU)

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: collaborator

Institut Toulousain d'Ostéopathie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loïc TREFFEL, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Toulousain d'Ostéopathie

Locations

Institut Claudius Regaud Toulouse Oncopole

Toulouse, , France

Countries

France

Other Identifiers

RCB: 2022-A01349-34

Identifier Type: -

Identifier Source: org_study_id