Breast CancerIPODNCT02621437
Impact of Osteopathy on Pain After Breast Cancer Surgery
A study testing Osteopathy sessions and phone questionnaires in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Osteopathy sessions and phone questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jun 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult woman
- Surgery for a malignant breast tumor with sentinel lymph node technique
- Patient affiliated to a social security system
- Willing and able to provide written informed consent
Who cannot join
- Under-age women
- Pregnant woman
- Surgery for a malignant breast tumor with lymph node dissection
- Receiving adjuvant therapy during the study
- Receiving physiotherapy sessions (other than those made in immediate post-operative)
- Participating in the space "Au Fil de Soi": relaxing body massage and Energy Resonance by Cutaneous Stimulation (RESC)
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- Person under guardianship or supervision
- Patient with impaired cognitive functions or lack of understanding of the French language
- Presenting a contraindication for osteopathy (major infectious and inflammatory conditions, trauma and other severe diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.
Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).
Read more
The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.
This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.
- Conditions
- Breast Cancer
- Being tested
- Osteopathy sessions, phone questionnaires
- Keywords
- pain, quality of life, osteopathy, oncology, surgery, breast
- Medical subject headings
- Breast Neoplasms, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathy sessionsOther
- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
phone questionnairesOther
Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
- pain questionnaire with digital scale,
- quality of life survey: SF-12
- HAD (Hospital and Anxiety Depression) questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (osteopathy) | Experimental | Patients will have three sessions of osteopathy and 6 phone questionnaires. Receives: Other: Osteopathy sessions; Other: phone questionnaires |
| control group | Other | Patients will have 6 phone questionnaires. Receives: Other: phone questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at Day 9
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at day 20
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at day 26
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at Day 34
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at Day 40
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Measured: at Day 48
Secondary outcomes (12)
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 9
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 20
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 26
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 34
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 40
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Measured: at day 48
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 9
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 20
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 26
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 34
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 40
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Measured: at Day 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2020
- Study completionJun 2020
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil DUBERNARD, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621437
- Sponsor's protocol ID
- 69HCL14_0456
- Acronym
- IPOD
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02621437
- Acronym / sponsor ID
- IPOD / 69HCL14_0456
- Conditions
- Breast Cancer
- Keywords
- pain, quality of life, osteopathy, oncology, surgery, breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.
Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).
The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.
This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (osteopathy) | Experimental | Other: Osteopathy sessions, Other: phone questionnairesPatients will have three sessions of osteopathy and 6 phone questionnaires. |
| control group | Other | Other: phone questionnairesPatients will have 6 phone questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult woman
- Surgery for a malignant breast tumor with sentinel lymph node technique
- Patient affiliated to a social security system
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Under-age women
- Pregnant woman
- Surgery for a malignant breast tumor with lymph node dissection
- Receiving adjuvant therapy during the study
- Receiving physiotherapy sessions (other than those made in immediate post-operative)
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 |
|---|---|---|
| Osteopathy sessions- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery), | Other | Intervention group (osteopathy) |
| phone questionnairesSix phone questionnaires (D9, D20, D26, D34, D40 and D48): * pain questionnaire with digital scale, * quality of life survey: SF-12 * HAD (Hospital and Anxiety Depression) questionnaire | Other | Intervention group (osteopathy), control group |
Primary outcome
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at Day 9
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at day 20
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at day 26
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at Day 34
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at Day 40
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time frame: at Day 48
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
12 secondary outcomes
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 9
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 20
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 26
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 34
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 40
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Time frame: at day 48
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 9
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 20
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 26
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 34
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 40
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Time frame: at Day 48
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 28 Jan 2021.
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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.
Gil DUBERNARD, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathy sessions and phone questionnaires in people with Breast Cancer, run by Hospices Civils de Lyon 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 4 inclusion and 9 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 28 Jan 2021. 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?
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery (time frame: at Day 9). The study lists 6 primary outcomes in all. 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 28 Jan 2021.