Algology in Oncology Osteopathic Support (ALGOS)

Trial Title: Algology in Oncology Osteopathic Support (ALGOS)

NCT ID: NCT05726929

Condition: Breast Cancer
Neuropathic Pain

Conditions: Official terms:
Neuralgia
Capsaicin

Conditions: Keywords:
Supportive care
Osteopathy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Osteopathic treatment
Description: Osteopathic Manual Treatment
Arm group label: Osteopathic treatment (OT)

Intervention type: Other
Intervention name: Capsaicin QUTENZA Patch (TAU)
Description: Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service
Arm group label: Osteopathic treatment (OT)
Arm group label: Treatment As Usual (TAU)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Institut Claudius Regaud Toulouse Oncopole

Address:
City: Toulouse
Zip: 31100
Country: France

Status: Recruiting

Contact:
Last name: Marie Bourguoin, MD

Phone: +33531155753
Email: bourgouin.marie@iuct-oncopole.fr

Start date: January 11, 2023

Completion date: December 8, 2024

Lead sponsor:
Agency: Institut Toulousain d'Ostéopathie
Agency class: Other

Collaborator:
Agency: Institut Claudius Regaud
Agency class: Other

Source: Institut Toulousain d'Ostéopathie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05726929