Please note that as of 14 August 2020 the researchers are still looking for participants. Please see the contact details below if you think you might like to take part.
A clinical trial that could significantly improve quality of life for women with moderate arm lymphoedema is underway in Hamilton.
A new potentially revolutionary surgical technique is being trialed for the treatment of upper limb lymphoedema following breast cancer treatment. The goal is to improve quality of life, reduce the size of the affected arm and improve appearance.
The trial is recruiting for new participants and researchers want to hear from you if you meet the following criteria and want to take part:
- You have experienced at least moderate lymphoedema for a minimum of six months.
- You have no known active breast cancer at this time (a recent appointment with your oncologist that confirms this needs to have taken place or be arranged).
- You live in or near the Waikato. If you are not in the Waikato, you would need to be able to travel to Hamilton to meet the needs of the trial. These will be discussed with you after you apply.
Mr Winston McEwan (a Waikato Plastic Surgeon) is heading this Hamilton-based clinical trial looking into the benefits of lymph node grafting for lymphoedema under the auspices of the Waikato Breast Cancer Research Trust (WBCRT).
The Co-Investigator is Waikato Breast and General Surgeon, Ian Campbell; who is also Professor of Surgery, Waikato Clinical Campus, Faculty of Health Sciences, University of Auckland.
Prof Campbell sat down with us recently to explain the potential benefits if this trial is a success and how to apply to take part if you are interested.
About the trial
Lymphoedema is a condition experienced by 5-20% of people who undergo axillary (armpit) lymph node dissection – an operation often performed as part of breast cancer surgery. The study is trialing lymph node grafting surgery, where two nodes are taken from the groin and implanted into the elbow and wrist.
The clinical trial is the first of its type in the world, Prof Campbell says. The procedure is Mr McEwan’s initiative and Prof Campbell is working with him on the trial – they are both performing surgeries. “We hope it’s going to bring a new and relatively simple treatment for lymphoedema. If successful, this could be life-changing for many women,” Prof Campbell said.
The work began with a pilot study of 10 women, and 4 of the women had positive outcomes. Some of the women were able to throw away their compression sleeve. With these promising results, a randomised study has begun to thoroughly investigate whether lymph node grafting is effective and whether it has any significant downsides.
Randomised means allocating people to different groups by chance – in this case to either have lymph node grafting plus standard care, or standard care alone. This means that if you apply, you have a 50/50 chance of being placed in either group – you do not get to choose, and nor does your surgeon, so that any confounding biases between the surgery group and the control group are minimised.
Women applying to take part are allocated to either:
- receive the lymph node grafting surgery and standard lymphoedema
- receive standard lymphoedema therapy (known as best alternative care) with self-administered massage, therapeutic exercise, use of a compression sleeve, and skin and nail care.
If the study shows a definite benefit from the lymph node grafting technique, Prof Campbell says women in the second group will be able to access the surgery at no cost via the public hospital system.
The trial could be game-changing
“This could be a potentially massive breakthrough for women,” Prof Campbell says of the new surgery technique. “There is no other lymphoedema therapy that enables women to stop wearing their compression sleeve. Most of the other procedures are major operations that are only available in a small number of centres. Liposuction and removal of tissue from the arm is sometimes carried out in New Zealand, but that’s a major procedure, and still requires wearing compression sleeves afterwards.”
Prof Campbell says the study needs to be done to ensure that the positive results seen in the pilot study are real, and provide a lasting outcome, as lymphoedema can sometimes fluctuate. “That’s why it’s so important we have more women take part in the trial.” Women taking part need to be aware of the risks, which will be explained when people apply.
The study needs 64 women in total – 32 in the surgery group and 32 in the non-surgery group. Another 24 women are needed to reach the total required for a valid study.
Prof Campbell says he and Mr McEwan have been involved in a wide range of research. The study is being coordinated from the WBCRT offices based at Waikato Hospital in Hamilton. Surgeries and trial visits are carried out at either Alison Surgical Centre, St Anne Breast Care, Braemar Hospital, Tu Tonu Rehabilitation Health Centre or Waikato Hospital.
The WBCRT has coordinated a number of multi-centre international trials covering a range of treatments, including introducing sentinel node biopsy to New Zealand, studies into endocrine treatments for breast cancer, breast cancer prevention and other drug treatments. Prof Campbell has assisted research into inequities in breast cancer detection and treatment among Māori and Pacific Island women, compared to European New Zealanders, with University of Waikato Professor of Population Health, Prof Ross Lawrenson. This work has helped identify improvements needed to improve care for all women in New Zealand, and has been welcomed by Breast Cancer Aotearoa Coalition.
How to take part in the trial:
If you are interested in applying to take part in the clinical trial into lymph node grafting, or if you have any questions:
- Heather Flay (Research Nurse/Trial Coordinator), mobile 0274 917 760 or email Heather.Flay@waikatodhb.health.nz OR
- Jenni Scarlet, (Research Nurse/back-up Trial Coordinator), phone 07 839 8726 Ext 97916 or email Jenni.Scarlet@waikatodhb.health.nz
How the trial works
After applying, Heather (or Jenni) will initially discuss with you details of your lymphoedema to confirm if you are eligible for the next step – which is assessment in person. The assessment will include identifying if you meet other criteria including:
- a minimum difference of arm volume of 200ml compared to the other arm, and
- having lymphoedema confirmed with an Impedence Plethysmography (which measures resistance of the tissue to electrical currents – if you have fluid in the arm, the resistance differs from subcutaneous fat).
For the women in the surgery group of the trial:
The lymph node grafting surgery involves incisions to the groin about 5cm long to harvest two nodes, then two small incisions are made above the wrist and above the elbow less than 1cm long to implant the nodes.
“It is not a big operation,” Prof Campbell says. “It takes about one hour, and may be carried out under local or general anaesthetic depending on the patient’s circumstances.” Women will need two to three days off work afterwards.
Six months after the surgery, there will be a lymphoscintiscan – an injection of a tiny amount of radioactive fluid to confirm if the implanted nodes are working.
For women in both groups:
Arms will be measured when participants join the trial, after six months, one year and two years to make comparisons and measure progress.
“We will stay in touch with all participants as it is important the women feel supported. We will address any questions or concerns before, during and after the trial.”
Prof Campbell says that if the trial is successful, many women with lymphoedema after breast cancer can look forward to greatly improved quality of life.
“We really hope lymph node grafting will be proven to be a viable and attractive option because we know how difficult it can be for a woman to have to wear a compression sleeve, along with the daily reminder of her diagnosis of breast cancer. We would love to be able to provide a solution that gives women peace of mind and improved quality of life.”
- The WBCRT, Braemar Hospital, Alison Surgical Centre, St Anne Breast Care and a Cancer Society of New Zealand research grant are providing financial support for the study.
25 April 2020