Effect of Mechanical Stimulation on Mastectomy Scars

NCT ID: NCT02702050

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-03-29

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional treatment group

Conventional treatment group 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. No mechanical stimulation will be given.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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)

Mechanical stimulation group

A 10 minute mechanical stimulation program - 'Mechanical stimulation (LPG system; Cellu M6 Integral I), will be provided after each of the twelve sessions of conventional treatment.

Group Type: EXPERIMENTAL

Mechanical stimulation (LPG system; Cellu M6 Integral I)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

Intervention Type: OTHER

Other Intervention Names

Therapeutic massager

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Queen Elizabeth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ka Po Andrea LEUNG

Senior Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea KP LEUNG, MSc

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department ,Queen Elizabeth Hospital

Locations

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

KC/KE-15-0816/FR-3

Identifier Type: -

Identifier Source: org_study_id