Breast CancerOSTEOPATHIENCT01403168

Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

A study testing OSTEOPATHY + conventional analgesic treatments and Conventional analgesic treatments in people with Breast Cancer, run by Centre Leon Berard at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is an open, prospective, controlled, randomized, comparative study with 2 arms. The purpose of the study is to assess the efficacy of osteopathy after breast surgery. 80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year. 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 + conventional analgesic treatments and Conventional analgesic treatments
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteFrance
Study dates: Apr 2011to Apr 2015
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

woman >= 18 years
pain (median VAS >=3 on the week prior to inclusion)
mastectomy or tumorectomy with axillary dissection <= 12 months
PS <=2
able to write, understand and read French
signed informed consent

Who cannot join

no pain
immediate breast reconstruction
history of cognitive or psychiatric troubles

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Leon Berard
Lyon, 69373

Other trials in France

About this study

This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

Conditions: Breast Cancer
Being tested: OSTEOPATHY + conventional analgesic treatments, Conventional analgesic treatments
Keywords: Osteopathy, Breast cancer, Pain
Medical subject headings: Breast Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OSTEOPATHY + conventional analgesic treatmentsOther
5 sessions for osteopathy are planned and will start in the 15 days following the enrollment.
The conventional analgesic treatments will be administered in the 15 days following the enrollment.
Conventional analgesic treatmentsOther
These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.

Study groups in NCT01403168
Study group	Role	What they receive
osteopathy + conventional analgesic treatments	Experimental	Not described Receives: Other: OSTEOPATHY + conventional analgesic treatments
conventional analgesic treatments	Placebo comparator	Not described Receives: Other: Conventional analgesic treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of the osteopathy treatment on pain
Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Apr 2015

First posted27 Jul 2011 (estimated)
Study startApr 2011
Primary completionApr 2014
Study completionApr 2015

Why it stopped: Recruitment difficulties

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Centre Leon BerardThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01403168
Sponsor's protocol ID: OSTEOPATHIE
Acronym: OSTEOPATHIE
Status last verified: Jun 2015
First submitted: 21 Jul 2011
Last updated: 29 Jun 2015
Results posted: No
Data monitoring committee: No

Publications

Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.
PubMed 12351281
Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
PubMed 1637663
Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.
PubMed 12855309
Labreze L, Dixmerias-Iskandar F, Monnin D, Bussieres E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. French.
PubMed 17371770
Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
PubMed 12218520
Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.
PubMed 8740607
Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.
PubMed 17038030
Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. doi: 10.7556/jaoa.1996.96.2.113.
PubMed 8838907
Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. doi: 10.5694/j.1326-5377.2002.tb04459.x.
PubMed 12041633
Licht PB, Christensen HW, Hoilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52. doi: 10.1067/mmt.2003.42.
PubMed 12532139
Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. doi: 10.1136/bmj.319.7218.1176. No abstract available.
PubMed 10541511
Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.
PubMed 15083985
Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.
PubMed 17122030

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
ClinicalTrials.gov ID: NCT01403168
Acronym / sponsor ID: OSTEOPATHIE / OSTEOPATHIE
Conditions: Breast Cancer
Keywords: Osteopathy, Breast cancer, Pain
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment difficulties
Enrolment: 28 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Study start: Apr 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 27 Jul 2011 (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.

This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
osteopathy + conventional analgesic treatments	Experimental	Other: OSTEOPATHY + conventional analgesic treatments
conventional analgesic treatments	Placebo comparator	Other: Conventional analgesic treatments

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

woman >= 18 years
pain (median VAS >=3 on the week prior to inclusion)
mastectomy or tumorectomy with axillary dissection <= 12 months
PS <=2
able to write, understand and read French

Key exclusion criteria (3 listed)

no pain
immediate breast reconstruction
history of cognitive or psychiatric troubles

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 + conventional analgesic treatments5 sessions for osteopathy are planned and will start in the 15 days following the enrollment. The conventional analgesic treatments will be administered in the 15 days following the enrollment.	Other	osteopathy + conventional analgesic treatments
Conventional analgesic treatmentsThese treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.	Other	conventional analgesic treatments

Primary outcome

Efficacy of the osteopathy treatment on pain
Time frame: 3 months
Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.

Results and safety

The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
Background: PubMed 12351281Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.
Background: PubMed 1637663Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
Background: PubMed 12855309Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.
Background: PubMed 17371770Labreze L, Dixmerias-Iskandar F, Monnin D, Bussieres E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. French.
Background: PubMed 12218520Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
Background: PubMed 8740607Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.
Background: PubMed 17038030Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.
Background: PubMed 8838907Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. doi: 10.7556/jaoa.1996.96.2.113.
Background: PubMed 12041633Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. doi: 10.5694/j.1326-5377.2002.tb04459.x.
Background: PubMed 12532139Licht PB, Christensen HW, Hoilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52. doi: 10.1067/mmt.2003.42.
Background: PubMed 10541511Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. doi: 10.1136/bmj.319.7218.1176. No abstract available.
Background: PubMed 15083985Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.

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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Gisele CHVETZOFF, MD principal investigator

Centre Leon Berard

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 + conventional analgesic treatments and Conventional analgesic treatments in people with Breast Cancer, run by Centre Leon Berard 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Jun 2015. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

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?

Efficacy of the osteopathy treatment on pain (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01403168, which also lists 13 linked publications.

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 29 Jun 2015.