Breast CancerALGOSNCT05726929
Algology in Oncology Osteopathic Support (ALGOS)
A study testing Osteopathic treatment and Capsaicin QUTENZA Patch (TAU) in people with Breast Cancer and Neuropathic Pain, run by Institut Toulousain d'Ostéopathie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Neuropathic Pain
- What is being tested?
- Osteopathic treatment and Capsaicin QUTENZA Patch (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2023to 8 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Algology in Oncology Osteopathic Support
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.
Read the 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
- Being tested
- Osteopathic treatment, Capsaicin QUTENZA Patch (TAU)
- Keywords
- Supportive care, Osteopathy
- Medical subject headings
- Breast Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
Osteopathic Manual Treatment
Capsaicin QUTENZA Patch (TAU)Other
Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic treatment (OT) | Experimental | Osteopathic treatment, 3 sessions of 1h + Treatment As Usual (TAU) Receives: Other: Osteopathic treatment; Other: Capsaicin QUTENZA Patch (TAU) |
| Treatment As Usual (TAU) | Active comparator | Treatment As Usual, Capsaicin Qutenza Patch (Conventionnal Treatment in algology in supportive care) Receives: Other: Capsaicin QUTENZA Patch (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes of test / Day 0 (inclusion) / every 3 months / at the end of the study 9 months after inclusion
Secondary outcomes (2)
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
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start11 Jan 2023
- Primary completion8 Dec 2024
- Study completion8 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Toulousain d'Ostéopathie
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Claudius Regaud
- Responsible party
- Sponsor
- Investigators
- Loïc TREFFEL, PhD, Principal investigator, Institut Toulousain d'Ostéopathie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726929
- Sponsor's protocol ID
- RCB: 2022-A01349-34
- Acronym
- ALGOS
- Status last verified
- Feb 2025
- First submitted
- 12 Jan 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algology in Oncology Osteopathic Support
- ClinicalTrials.gov ID
- NCT05726929
- Acronym / sponsor ID
- ALGOS / RCB: 2022-A01349-34
- Conditions
- Breast Cancer, Neuropathic Pain
- Keywords
- Supportive care, Osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut Toulousain d'OstéopathieUniversity, hospital or other
- Collaborators
- Institut Claudius Regaud
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 8 Dec 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic treatment (OT) | Experimental | Other: Osteopathic treatment, Other: Capsaicin QUTENZA Patch (TAU)Osteopathic treatment, 3 sessions of 1h + Treatment As Usual (TAU) |
| Treatment As Usual (TAU) | Active comparator | Other: Capsaicin QUTENZA Patch (TAU)Treatment As Usual, Capsaicin Qutenza Patch (Conventionnal Treatment in algology in supportive care) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatmentOsteopathic Manual Treatment | Other | Osteopathic treatment (OT) |
| Capsaicin QUTENZA Patch (TAU)Capsaicin QUTENZA Patch is the treatment as usual (TAU) delivered in the medical algology service | Other | Osteopathic treatment (OT), Treatment As Usual (TAU) |
Primary outcome
Changes in Neuropathic pain assessment from baseline to 9 months
Time frame: 5 minutes of test / Day 0 (inclusion) / every 3 months / at the end of the study 9 months after inclusion
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
2 secondary outcomes
Changes in Brief Pain Inventory from baseline to 9 months
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc TREFFEL, PhD principal investigator
Institut Toulousain d'Ostéopathie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment and Capsaicin QUTENZA Patch (TAU) in people with Breast Cancer and Neuropathic Pain, run by Institut Toulousain d'Ostéopathie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neuropathic pain assessment from baseline to 9 months (time frame: 5 minutes of test / Day 0 (inclusion) / every 3 months / at the end of the study 9 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.