Effect of Mechanical Stimulation on Mastectomy Scars

Breast Cancer Clinical Trial

Official title:

A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702050
• Other study ID #: KC/KE-15-0816/FR-3
• Status: Completed
• Phase: N/A
• First received: February 26, 2016
• Last updated: April 3, 2018
• Start date: March 2016
• Est. completion date: March 29, 2018

Study information

• Verified date: April 2018
• Source: The Queen Elizabeth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Mechanical stimulation (LPG system; Cellu M6 Integral I)
For the mechanical stimulation group, an additional ten-minute mechanical stimulation will be provided in each of the twelve sessions of convention treatment program. The device produced skin lift through suction via a treatment head with 2 rollers installed. It was a non-invasive technique which aimed to mobilize soft tissues by creating skin folds and stretching the underlying soft tissues while manipulating the treatment head according to protocol.
• Conventional treatment
Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises, within a 6-week period (i.e., two sessions per week)

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Queen Elizabeth Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancouver Scare Scale (VSS) to study scar appearance	A scar scale to quantify scar appearance by observing the thickness, pliability, pigmentation and vascularity of mastectomy scar. The former two items were rated on ordical scales whereas the later two items in a descriptive manner. Total score ranged from 0 to 13.	6 months
Primary	Spectrophotometry to measure scar color	A spectrophotometer (Hunterlab Miniscan Ez4500S, USA) is used to measure level of lightness, redness and yellowness of the mastectomy scar versus adjacent normal skin. Level of redness indicated vascularization and pigmentation represented significance of melanin deposited in a scar.	6 months
Secondary	Numeric pain rating scale (NPS) to study pain over affected breast	11-item numeric rating scale (NRS) is valid, reliable and appropriate for use in clinical setting for pain measurement	6 months
Secondary	Shoulder range by goniometry	Shoulder range of motion (ROM) will be evaluated by measuring active shoulder flexion and abduction	6 months
Secondary	Grip strength by hand-held dynamometer	The hand grip strength will be evaluated using the JAMAR Hydraulic Hand Dynamometer	6 months
Secondary	Arm function	The Chinese version of the Disabilities of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire will be used as an outcome measurement for upper extremities disabilities and symptoms.	6 months
Secondary	Quality of life	The Functional Assessment of Chronic Illness Therapy - Breast Cancer (FACT-B), traditional Chinese version 4 questionnaire would be adopted for measurement of quality of life for women with breast cancer	6 months