NCT02621437

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

November 27, 2015

Last Update Submit

January 27, 2021

Conditions

Breast Cancer

Keywords

painquality of lifeosteopathyoncologysurgerybreast

Outcome Measures

Primary Outcomes (6)

  • 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).

    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).

    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).

    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).

    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).

    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).

    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.

    at day 9

  • Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    at day 20

  • Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    at day 26

  • Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    at day 34

  • Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.

    at day 40

  • +7 more secondary outcomes

Study Arms (2)

Intervention group (osteopathy)

EXPERIMENTAL

Patients will have three sessions of osteopathy and 6 phone questionnaires.

Other: Osteopathy sessionsOther: phone questionnaires

control group

OTHER

Patients will have 6 phone questionnaires.

Other: phone questionnaires

Interventions

Osteopathy sessionsOTHER

\- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),

Intervention group (osteopathy)
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

Intervention group (osteopathy)control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynécologie

Lyon, 69004, France

Location

MeSH Terms

Conditions

Breast NeoplasmsPainNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gil DUBERNARD, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 3, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

FR(1)