Know Cancer

or
forgot password

Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Does Scar Tissue Massage Improve Postoperative Pain and Function in Women With Breast Cancer? A Randomized Controlled Study.


This is a prospective randomized controlled trial design. Women who have undergone breast
cancer surgery (breast conserving surgery or mastectomy) and who meet the eligibility
criteria specified will be offered study participation. After obtaining informed consent,
subjects will be randomized between two cohorts: scar massage (intervention group) versus
no scar massage (control group). The primary outcome is scar-related pain (scored using the
McGill Pain Questionnaire Short Form). The secondary outcomes are: upper body range of
motion, physical parameters of the scar (pliability, scar height, vascularity and
pigmentation scored using the Vancouver Scar Scale), lymphedema (evaluated by arm
circumference measurements) and quality of life (using the Functional Assessment of Cancer
Therapy (FACT)-B breast cancer-specific instrument).

A sample size of 143 patients per arm was estimated to detect a 30% difference in the
primary outcome of postoperative scar-related pain between the intervention and the control
groups with 80% statistical power.


Inclusion Criteria:



- Patients must be able to provide informed consent and be physically able to perform
daily self-administered breast scar massage

- Female or male patients with histologically-confirmed invasive or in situ breast
cancer

- Definitive surgery with BCS or mastectomy +/- axillary dissection or sentinel node
sampling

- Adequate surgical healing as judged by treating oncologist during pre-enrolment
assessment

- Age 18 years or older with ability to provide written informed consent.

- Ability to start massage within 8 weeks from surgery and comply with daily regimen if
randomized to the intervention cohort

- Ability to comply with not performing massage if randomized to the control cohort

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcome is scar-related pain (scored using the McGill Pain Questionnaire Short Form).

Outcome Time Frame:

Two years

Safety Issue:

No

Principal Investigator

Pauline Truong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia

Authority:

Canada: Health Canada

Study ID:

R03-0011

NCT ID:

NCT00175344

Start Date:

February 2004

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • scar massage
  • breast conserving surgery
  • scar pain
  • quality of life
  • Breast cancer treated with breast conserving surgery with or without axillary dissection or sentinel node sampling.
  • Breast Neoplasms
  • Pain, Postoperative
  • Cicatrix

Name

Location