Clinical trial NCT02702050: Effect of Mechanical Stimulation on Mastectomy Scars
Official title: A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Physiotherapy
Mechanical Stimulation
Mastectomy Scar
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in:

(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.

Detailed description: Background:

Breast cancer is common among women. After surgical interventions like mastectomies, women with breast cancer may suffer physical, emotional and psychosocial complications. Evidence suggests that comprehensive physiotherapy program, including patient education, manual techniques, therapeutic exercises and compression bandaging, is effective in managing the above complications. Scarring was frequently overlooked in past studies. Besides cosmetic issues, a post mastectomy scar may cause adverse physical, functional, and psychological outcomes. The effects of mechanical stimulation on mastectomy scars have not been well investigated yet.

Objectives:

To investigate the efficacy of mechanical stimulation in:

(i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.

Setting:

Out-patient physiotherapy breast care clinic at the Hong Kong Queen Elizabeth Hospital

Participants:

One hundred and eight women with breast cancer after mastectomy in recent 6 weeks will be recruited.

Methodology:

An assessor-blind, randomized controlled trial will be conducted. 108 women with breast cancer after mastectomy will be recruited from the breast care clinic of the Queen Elizabeth Hospital. They will be randomly allocated by block randomization method into either the mechanical stimulation group (n= 54) or conventional treatment group (n=54).

Both study groups will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. For the mechanical stimulation group, a ten-minute mechanical stimulation program will be provided. For the conventional treatment group, no mechanical stimulation will be given.

Primary outcomes include scar evaluations by the Vancouver Scar Scale and spectrophotometry. Secondary outcomes are composite measurements of shoulder morbidities, including numeric pain rating scale (NPS), shoulder range of movement and hand grip strength; arm function as evaluated by the Disabilities of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire; and quality of life as measured by the Functional Assessment of Chronic Illness Therapy - Breast Cancer (FACT-B). Outcome assessments at baseline, immediately after the 6-week program, and 3-month follow-up periods will be conducted by blinded assessors at the breast care clinic.

Data Analysis:

The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Sciences version 21.0. Alpha level will be set at 0.05.

Potential Clinical Significance of Study:

Improvement of physiotherapy in scar management might potentially improve scar appearance - pigmentation, vascularity, pliability and thickness, decrease shoulder morbidities, improve upper limb functions, and enhance quality of life for women with breast cancer after mastectomy. If the mechanical stimulation protocol is proven to be effective, it will bring about significant advances in physiotherapy practice in post-mastectomy care in an evidence-based manner.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 years old or above with mastectomy performed in recent 6 weeks;
* Able to attend physiotherapy treatment and follow-ups during the study period.

Exclusion Criteria:

* Altered mental state for cooperation and informed consent;
* Signs and symptoms of mastectomy scar infections or inflammations;
* Unhealed mastectomy wounds;
* History of lymphoedema;
* Diagnosed bilateral breast cancers;
* Unstable medical or cardiovascular conditions;
* Pre-existing arm impairments/dysfunctions that will affect testing or exercising the affected arm;
* Receiving radiotherapy during the study period;
* Known sensitivity to mechanical stimulation;
* Skin cancer on the treatment area;
* Unclear cut margins of the cancer;
* Known metastasis to other areas;
* HIV positive.

Primary outcomes:
measure: Vancouver Scare Scale (VSS) to study scar appearance
timeFrame: 6 months
measure: Spectrophotometry to measure scar color
timeFrame: 6 months
Secondary outcomes:
measure: Numeric pain rating scale (NPS) to study pain over affected breast
timeFrame: 6 months
measure: Shoulder range by goniometry
timeFrame: 6 months
measure: Grip strength by hand-held dynamometer
timeFrame: 6 months
measure: Arm function
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Physiotherapy Department ,Queen Elizabeth Hospital
name: Andrea KP LEUNG, MSc
role: PRINCIPAL_INVESTIGATOR
References: