Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000886785
Ethics application status
Not yet submitted
Date submitted
31/07/2013
Date registered
8/08/2013
Date last updated
8/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise reduce the incidence of lymphoedema more than advice alone following inguinal and pelvic node dissections for gynaecological cancer? – A Pilot Study.
Scientific title
Does exercise reduce the incidence of lymphoedema more than advice alone following inguinal and pelvic node dissections for gynaecological cancer? – A Pilot Study.
Secondary ID [1] 282938 0
nil
Universal Trial Number (UTN)
U1111-1146-2091
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gynaecological cancer
 289756 0
lymphoedema 289757 0
Condition category
Condition code
Cancer 290095 290095 0 0
Ovarian and primary peritoneal
Cancer 290096 290096 0 0
Cervical (cervix)
Cancer 290097 290097 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study will be the provision of a lower limb exercise programme. The 6 exercises are designed to slowly pump the muscles which will help squeeze fluid up the leg. They will be taught by the same physiotherapist to all the participants. The programme starts and finishes with diaphragmatic breathing to stimulate the deep lymphatic system. abdominal muscle contractions are followed by gluteal contactions, quadriceps and hamstring contactions and then gastrocnemius contractions. each exercise is repeated 20 times. theraband resistance is used for each exercise except for the abdominal contractions. the exercises will be taught by a physiotherapist on an individual basis. exercises will be undertaken twice a day for the 3 month trial period. The exercises should take 15 minutes to complete in the patient's own home

Each exercise will be repeated for 20 repetitions at intensity 13 on the Borg Rating of Perceived Exertion (RPE) The Borg Scale is a patient’s subjective measure of physical activity intensity level based on the physical sensations a person experiences during physical activity such as increased heart rate, increased respiration or breathing rate, increased sweating, and muscle fatigue (Borg, 1998). It is agreed that perceived exertion ratings between 12 to 14 on the Borg Scale suggests that physical activity is “somewhat hard” being performed at a moderate level of intensity.
The exercises are graded level 1 (easier) or level 2 (harder)and commence day 1 after surgery with no hip movement for the first 48hours to reduce strain on the suture line in the early post-operative period. Patients can choose which exercise level suits them best to gain level 13 on the Borg Scale. Each participant will be provided with an exercise protocol sheet containing written and pictorial description of all the exercises to ensure they are replicated exactly. Each participant will have their exercise regime checked at every review appointment by the same physiotherapist that prescribed the regime to ensure consistency of technique between the participants. review appointments consist of 40 minute consultations with the physiotherapist at baseline, 1 month, 6 weeks after chemotherapy, 6 weeks after radiotherapy or at 3 months if no adjuvant therapies occur
The intervention group will also receive current standard care. They will be provided with an education leaflet by the physiotherapist detailing strategies to reduce the risk of triggering lymphoedema. Ryan et al (2004) report that patients identified the initial trigger for lower limb lymphoedema and those that exacerbate LLL symptoms. Trigger factor avoidance includes:Skin care – avoiding trauma and injury to reduce infection risk. Avoiding limb constrictions – items that leave deep tissue indentations, Weight maintenance – including the promotion of general exercise to maintain weight and stimulate the lymphatic system, Travel – regular foot and leg exercises for prolonged travel. Compression garments for flights longer than 4 hours, Avoiding extremes of temperature – including saunas and steam rooms, Pre-existing medical condition control – hypertension, cardiac disease, diabetes, thyroid disease, kidney and liver disease. Pre-existing lower limb oedema may require compression therapy especially in those with occupations where prolonged sitting and standing
Written informed consent will be gained from each participant
adherance will be monitored by an exercise partcipation diary completed by the patient
Intervention code [1] 287641 0
Prevention
Intervention code [2] 287673 0
Rehabilitation
Comparator / control treatment
The control group will undertake current standard care. They will be provided with an education leaflet by the physiotherapist detailing strategies to reduce the risk of triggering lymphoedema as outlined in the intervention above
Control group
Active

Outcomes
Primary outcome [1] 290135 0
The primary outcome is incidence of lymphoedema.

For the purpose of this study lymphoedema will be defined as 10% limb volume increase, with a concurrent change of 10 points on L-Dex bioimpedence from preoperative baseline in unilateral lymph node dissections.
At present there is no consensus on which measurement or combination of measurement methods reflect the most accurate diagnostic tool.
Circumferential measurements will be undertaken at every consultation using a perometer. Perometry is a sensitive standardised device that uses infrared optoelectric technology to detect and quantify limb volume changes. Perometry is a rapid, simple, non-invasive, reliable measurement tool to determine limb volume in Breast Cancer Related Lymphoedema (Deltombe 2009) The perometer calculates total limb volume and millilitres via a truncated cone formula. Total limb volume includes fat and muscle mass as well as extracellular fluid. A two stage measurement will occur. First from the ankle to the groin, then the foot.
Timepoint [1] 290135 0
Data will be collected preoperatively, 1 month post operatively, 6 weeks after chemotherapy or radiotherapy, or at 3 months if no adjuvant therapies are required.
Pre-operative measurements are vital for this study to account for pre-existing normal interface variance. This may range from 3-10% depending on arm dominance, adiposity and muscularity (Stout). An accurate diagnosis of early post-operative lymphoedema cannot be made unless premorbid limb volume disparity is quantified and regular follow up conducted to monitor for limb volume change. (Stout)
Data collection will be scheduled alongside a patient’s normal postoperative / post adjuvant therapy review appointments with the gynaeoncology multidisciplinary team. Any participant complaining of subjective signs and symptoms of lymphoedema in the 3 months study will be given an extra measurement for diagnostic purposes only.
Primary outcome [2] 290136 0
the primary outcome is Incidence of lymphoedema

For the purpose of this study lymphoedema will be defined as 10% limb volume increase, with a concurrent change of 10 points on L-Dex bioimpedence from preoperative baseline in unilateral lymph node dissections.
At present there is no consensus on which measurement or combination of measurement methods reflect the most accurate diagnostic tool.
The U400 bioimpedence spectroscopy will calculate the L-Dex directly. Bioimpedence spectroscopy assesses extracellular fluid and has been proven to identify subclinical lymphoedema i.e. increases in extracellular fluid before clinical objective signs of lymphoedema present. This is a measure of extracellular fluid only, removing any limb volume changes caused by weight or muscle mass gain or loss. Bioimpedence will be used alongside perometry in unilateral cases to ensure that early subclinical lymphoedema is not missed as perometry may be insensitive to early changes in extracellular fluid.
At each follow up the evolution of the difference in limb volumes between affected and unaffected limbs will be compared to correct for weight gain. For this reason a participant’s body weight will also be measured at each visit using scales to control for weight change. The same physiotherapist will undertake all measurements at the same time of day for reliability.
Timepoint [2] 290136 0
Data will be collected preoperatively, 1 month post operatively, 6 weeks after chemotherapy or radiotherapy, or at 3 months if no adjuvant therapies are required.
Pre-operative measurements are vital for this study to account for pre-existing normal interface variance. This may range from 3-10% depending on arm dominance, adiposity and muscularity (Stout). An accurate diagnosis of early post-operative lymphoedema cannot be made unless premorbid limb volume disparity is quantified and regular follow up conducted to monitor for limb volume change. (Stout)
Data collection will be scheduled alongside a patient’s normal postoperative / post adjuvant therapy review appointments with the gynaeoncology multidisciplinary team. Any participant complaining of subjective signs and symptoms of lymphoedema in the 3 months study will be given an extra measurement for diagnostic purposes only.
Secondary outcome [1] 304002 0
Development of seroma, wound complications, co-morbidities, BMI and adjuvant radiotherapy and chemotherapy will be documented following consultation of the patients medical record to investigate their impact on the development of lymphoedema in this client group
Timepoint [1] 304002 0
1 month post operatively
6 weeks following chemotherapy
6 weeks following radiotherapy
or 3 months postoperatively if no adjuvant treatment occurs
Secondary outcome [2] 304003 0
A quality of life measure the EQ-5D-5L will be undertaken at each consultation
Timepoint [2] 304003 0
1 month postoperatively
6 weeks post chemotherapy
6 weeks post radiotherapy
or 3 months post operatively if no adjuvant therapy occurs

Eligibility
Key inclusion criteria
inguinal or pelvic lymph node dissection for gynaecological cancer management at Monash Medical Centre, Moorabbin campus.
English speaking or interpreter available
Able to provide informed consent
Able to attend regular follow up
Able undertake a lower limb exercise programme
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Are found to have premorbid disease causing pre-operative oedema e.g. severe varicose veins, DVT
Have metastatic or systemic disease
Have had previous inguinal or pelvic node dissections
Have any medical problem preventing them from undertaking the lower limb exercise programme e.g. severe joint pain preventing movement
Have cognitive impairment based on stated history in their medical record

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This pilot study is a prospective 2 group parallel RCT. 30 subjects will be randomised into an experimental group who will receive instruction in an exercise programme and taught lymphoedema trigger factor avoidance strategies or a control group who will be taught trigger avoidance strategies alone. The assistant researcher will attend the pre assessment clinic for gynaeoncology at Monash Health. Patients due to undergo inguinal or pelvic lymph node dissection will be highlighted from the clinic list. These patients are then identified as potential participants. Each participant will be verbally informed about the study and the committment required for participation to ensure adequate understanding of both the proposed research and the implications of participation in it. They will then be given written information to reiterate the verbal communication. They will be asked whether they consent to participating or not
Those that give consent will be required to complete and sign a consent form
For those undecided a follow up telephone call will be made 48 hours later. if they consent to participating a consent form will be mailed for completion
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a permuted blocks approach, and stratified by whether participants had unilateral or bilateral surgery. Personnel responsible for recruitment and baseline assessment will be unaware of the future sequence within the randomisation, the randomisation sequence will be generated by an investigator unaware of participant assessment findings
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1368 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 7230 0
3165 - Bentleigh East

Funding & Sponsors
Funding source category [1] 287715 0
Hospital
Name [1] 287715 0
Monash Health Physiotherapy Department
Country [1] 287715 0
Australia
Primary sponsor type
Individual
Name
Helen Eason
Address
Physiotherapy Department
Monash Medical Centre
Centre Road
East Bentleigh
Vic
3165
Country
Australia
Secondary sponsor category [1] 286445 0
Individual
Name [1] 286445 0
A Prof Terry Haines
Address [1] 286445 0
Allied Health Research Unit,
Monash Health
246 Clayton Road
Clayton VIC 3168
Country [1] 286445 0
Australia
Other collaborator category [1] 277559 0
Individual
Name [1] 277559 0
A Prof Thomas Jobling
Address [1] 277559 0
Gynaeoncology unit
Monash Medical Centre
Centre Road
East Bentleigh
Vic 3165
Country [1] 277559 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289671 0
Southern Health Human Research Ethics Committee A
Ethics committee address [1] 289671 0
Monash Medical Centre
246 Clayton Road
Clayton
vic
3168
Ethics committee country [1] 289671 0
Australia
Date submitted for ethics approval [1] 289671 0
01/08/2013
Approval date [1] 289671 0
Ethics approval number [1] 289671 0
EC00382

Summary
Brief summary
The aim of this study is to assess whether exercise combined with advice is more effective than advice alone in reducing the incidence of lymphoedema following surgery for gynaecological cancer.

Who is it for?
You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to undergo inguinal or pelvic lymph node dissection for gynaecological cancer management at Monash Medical Centre, Moorabbin campus.

Trial Details
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undertake a lower limb exercise programme and receive advice about the prevention of lymphoedema. The exercise programme will be taught by a physiotherapist and then completed by the participant in their own home. The exercises will take 15 minutes to complete twice a day for a 3 month duration. A rubber exercise band will be required for some of the exercises and will be provided by the physiotherapist at no cost to the participant.

Participants in the other group will receive advice only. this is provided by the physiotherapist in an education leaflet which details strategies for reducing the risk of triggering lymphoedema e.g. skin care, weight maintenance etc

Participants will be assessed pre-operatively, at 1 month post-operatively, and then at 6 weeks after chemotherapy or radiotherapy or at 3 months if no adjuvant therapies are required. The assessments will involve measurements of lower limb volume and completion of a quality of life questionnaire
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41878 0
Mrs Helen Eason
Address 41878 0
Physiotherapy Department
Monash Medical Centre
Centre Road
East Bentleigh
Vic 3165
Country 41878 0
Australia
Phone 41878 0
+61431704883
Fax 41878 0
+61 3 9928 8567
Email 41878 0
helen.eason@southernhealth.org.au
Contact person for public queries
Name 41879 0
Mrs helen eason
Address 41879 0
Physiotherapy Department
Monash Medical Centre
Centre Road
East Bentleigh
Vic 3165
Country 41879 0
Australia
Phone 41879 0
+61431704883
Fax 41879 0
+61 3 9928 8567
Email 41879 0
helen.eason@southernhealth.org.au
Contact person for scientific queries
Name 41880 0
Mrs helen eason
Address 41880 0
Physiotherapy Department
Monash Medical Centre
Centre Road
East Bentleigh
Vic 3165
Country 41880 0
Australia
Phone 41880 0
+61431704883
Fax 41880 0
+61 3 9928 8567
Email 41880 0
helen.eason@southernhealth.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.