None listed
Conditions
Brief summary
The main aim of this study is to assess the use of Physiotouch in treating secondary arm lymphoedema and tissue fibrosis in patients who have undergone unilateral surgical treatment for breast cancer. Participants will be females who have had breast cancer and have undergone unilateral mastectomy. Key exclusion criteria woman who: has received breast-cancer related treatment within the last 6 months, is pregnant, younger than age 18, have implantable devices, have heart problems, have a tendency to clot, or are predisposed to infection. Study details: Participants will not need to change any current conservative therapy they are receiving for their lymphoedema or tissue fibrosis. The PhysioTouch device will be use to administer treatment by professionals trained in the use of this device. All participants will be receiving the same treatment. This study will assess the possibility of Physiotouch, and negative pressure, being used as an alternative therapy to the current conservative management for lymphoedema and tissue fibrosis which only uses positive pressure.
Interventions
A hand held PhysioTouch unit which applies negative pressure will be used according to upper limb, local fibrosis and scar treatment guidelines outlined by PhysioTouch Australia and NZ. Its use may result in structural tissue changes leading to a decrease in the extent of lymphoedema associated fibrosis and scar tissue complications arising from the surgery or
radiotherapy.
Intervention will be delivered by two researchers trained in the use of PhysioTouch by a lymphoedema physiotherapist.
Part
A hand held PhysioTouch unit which applies negative pressure will be used according to upper limb, local fibrosis and scar treatment guidelines outlined by PhysioTouch Australia and NZ. Its use may result in structural tissue changes leading to a decrease in the extent of lymphoedema associated fibrosis and scar tissue complications arising from the surgery or radiotherapy. Intervention will be delivered by two researchers trained in the use of PhysioTouch by a lymphoedema physiotherapist. Participants will come into the lymphoedema clinical research unit at Flinders Centre for Innovation in Cancer individually and intervention will be delivered face-to-face for 20-30 minutes over 4 different sessions. The sessions will be run over 2 weeks with at least 48 hours between each session.
Sponsors
Neil Piller
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Unilateral arm lymphoedema following breast cancer with no preexisting risks or surgery on the other side OR - Chest wall scar tissue and/or fibrosis following breast cancer with no preexisting risks AND - Stage 2 arm lymphoedema in a female following treatment for breast cancer - Must be 6 months postsurgery, chemotherapy and or radiation treatment for breast cancer - Age over 18 years old
Exclusion criteria
- Diagnosis of active or recurrent cancer, or less than 6 months at the time of initial evaluation from completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer. - Diagnosis or suspected acute infection - Individuals with pacemaker or other implanted electronic devices - Diagnosis of acute thrombophlebitis (in last 2 months) - Receiving corticosteroids or immune suppressants - Presence of open wound or any skin inflammation, irritation of skin allergies - Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months - Diagnosis of pulmonary oedema - Diagnosis of congestive heart failure - Pregnancy - Any condition where increased venous or lymphatic return is undesirable - Inability or unwillingness to participate in all aspects of study protocol and or inability to provide informed consent - Currently participating in another clinical trial
Outcome results
None listed