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Trial registered on ANZCTR


Registration number
ACTRN12618002029279
Ethics application status
Approved
Date submitted
22/11/2018
Date registered
18/12/2018
Date last updated
22/08/2019
Date data sharing statement initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing two interventions to reduce the time needed to recover after surgery for ovarian cancer.

Scientific title
Testing individual Interventions to optimize Perioperative care in ovarian cancer Surgery (TIPS).
Secondary ID [1] 296655 0
CTC 0226
Secondary ID [2] 296656 0
ANZGOG 1614/2018
Universal Trial Number (UTN)
Trial acronym
TIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 310491 0
Condition category
Condition code
Cancer 309201 309201 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves randomly allocating participant into one of three study groups for the drink (intervention 1) and into one of two study groups for the pain medication capsule (intervention 2) as follows:

Intervention 1:
Drink 1: Carbo-loading drink (400 ml, 50g carbohydrate) to be consumed within 5-10 minutes, 2 hours before the operation
Drink 2: Water (400ml, 0g carbohydrates) to be consumed within 5-10 minutes, 2 hours before the operation
Drink 3: No drink (0ml, 0g carbohydrates).

Intervention 2:
Capsule 1: 75 mg pregabalin capsule 1 hour before the operation and about 12 hours after the first capsule
Capsule 2: Placebo capsule 1 hour before the operation and about 12 hours after the first capsule. A placebo is a medication with no active ingredients that is identical in appearance to the active medication.
Intervention code [1] 312964 0
Treatment: Other
Intervention code [2] 312965 0
Treatment: Drugs
Comparator / control treatment
For intervention 1 no drink is the control treatment for intervention 2 this is placebo controlled gelatin capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 308174 0
To assess the feasibility of the study interventions by measuring adherence to allocated treatment via direct supervision.
Timepoint [1] 308174 0
For intervention 1 assessed at 2 hours prior to surgery and for intervention 2, 1 hour prior to surgery and then 12 hours following the first dose.
Secondary outcome [1] 354156 0
To measure the proportion of patients who experience vomiting within 1 hour after CHO/control drink administration, assessed by direct observation, completion the "Discharge Measure Study Aid" and review of medical records.
Timepoint [1] 354156 0
For intervention 1, assessed at 1 hour prior to surgery (1 hour following drink administration).



Secondary outcome [2] 354157 0
To measure the proportion of patients with aspiration pneumonitis, assessed by hospital records.
Timepoint [2] 354157 0
Assessed at the following time points: Review of admission records at discharge, and 30 days post-surgery (for any occurrences after discharge)
Secondary outcome [3] 354158 0
To measure the proportion of patients with somnolence defined as a Ramsey sedation score of equal to or greater than 3, assessed by direct observation and recorded in the medical records.
Timepoint [3] 354158 0
Assessed at the following time points: on patient anaesthetic bay check in, at 6-9 AM on days 1 and 2 after surgery
Secondary outcome [4] 354160 0
To assess the palatability of the carbohydrate drink, assessed by asking participants to assess the taste of the drink immediately after drinking.
Timepoint [4] 354160 0
Assessed immediately after drinking.
Secondary outcome [5] 354161 0
To measure the time from the end of surgery until first bowel motion other than gas, assessed by asking the patient directly
Timepoint [5] 354161 0
Assessed at the following time points: once daily while patient remains admitted (up to 7 days post-surgery)
Secondary outcome [6] 354163 0
To measure the time from the end of surgery until first tolerance of regular intake of solid food (min 3 times daily) without vomiting or discomfort, assessed by asking the patient directly
Timepoint [6] 354163 0
Assessed at the following time points: once daily while patient remains admitted (up to 7 days post-surgery)
Secondary outcome [7] 354164 0
To assess pain over the first 48 hours after surgery (at 2, 4, 8, 12, 24 and 48 hours post-operatively), using patient questionnaire "assessment of current pain" tool.
Timepoint [7] 354164 0
48 hours post surgery of last randomised participant.
Secondary outcome [8] 354165 0
To measure the time from the end of surgery until first use of rescue analgesia defined as first press of Patient Controlled Analgesia (PCA) or bolus if Epidural anaesthesia (EDA) is used. Assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.
Timepoint [8] 354165 0
Until participant is discharged from hospital following surgery.
Secondary outcome [9] 354166 0
To assess the amount of morphine equivalents during the first 48 hours post-operatively. Assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.
Timepoint [9] 354166 0
48 hours post surgery of participant.
Secondary outcome [10] 354167 0
To assess the composite incidence of hunger, thirst, nausea, fatigue, drowsiness, trouble concentrating, diarrhoea, constipation, bloating, and aspects of well-being, collected using the measures of advanced ovarian cancer patients’ perioperative symptoms (MAPS) instrument.
Timepoint [10] 354167 0
Completed at screening (0-28 days prior to randomisation), within 1-2 hours before surgery, and between 6-9am on days 1, 2, 3 -7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge).
Secondary outcome [11] 354168 0
To measure time from admission to discharge from hospital, assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.
Timepoint [11] 354168 0
When participant is discharged from hospital.
Secondary outcome [12] 354169 0
To measure the proportion of patients who are re-admitted to hospital within 30 days after surgery, assessed via review of hospital records and a phone call to the participant.
Timepoint [12] 354169 0
30 days after surgery of participant.
Secondary outcome [13] 354170 0
To measure the number of days at home (or rehabilitation facility) within 30 days after surgery, assessed via review of hospital records and a phone call to the participant.
Timepoint [13] 354170 0
30 days after surgery of participant.
Secondary outcome [14] 354171 0
To measure the proportion of patients with postoperative complications according to the Clavien Dindo classification within 30 days after surgery.
Timepoint [14] 354171 0
30 days after surgery of participant.
Secondary outcome [15] 354172 0
To measure death from any cause within 30 days after surgery.
Timepoint [15] 354172 0
30 days after surgery participant.
Secondary outcome [16] 354984 0
To assess the acceptability of the pregabalin, assessed by documenting whether or not the patient took the pregabalin tablet.
Timepoint [16] 354984 0
Assessed immediately after taking.

Eligibility
Key inclusion criteria
1. Women aged 18 and older with suspected advanced malignancy of the ovary/fallopian tube or peritoneum.
2. Disease suspected to be at least Stage III disease at initial diagnosis.
3. Planned to undergo laparotomy (primary surgery or after neoadjuvant chemotherapy of a maximum 4 cycles of chemotherapy).
4. Adequate renal function (e.g. creatinine clearance greater than 50 ml/min).
5. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
6. Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of uncontrolled insulin-dependent diabetes mellitus.
2. Uncontrolled gastro-oesophageal reflux disease or disorders of gastric emptying.
3. Intestinal obstruction
4. Known allergy to pregabalin or to any ingredients of the Nutricia pre-op drink.
5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
6. Pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone or web based interface.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generation of the allocation sequence will be by computer generated random numbers using the method of minimisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Factorial
Other design features
Please note only the intervention group 2 will be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A total of 60 participants (20 per group for Factor 1, 30 per group for Factor 2) provides at least 80% power with a 1-sided type error rate of 5% to rule out a feasibility rate of 50% (not worthy of pursuit) if the true rate is 85% (worthy of pursuit). The total sample size of 60 is based on 3 groups of 20 for Factor 1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 12465 0
Westmead Hospital - Westmead
Recruitment hospital [2] 12495 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 12496 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 12498 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 24762 0
2145 - Westmead
Recruitment postcode(s) [2] 24875 0
2305 - New Lambton
Recruitment postcode(s) [3] 24876 0
6008 - Subiaco
Recruitment postcode(s) [4] 24878 0
3052 - Parkville
Recruitment outside Australia
Country [1] 21529 0
New Zealand
State/province [1] 21529 0
Christchurch

Funding & Sponsors
Funding source category [1] 301235 0
University
Name [1] 301235 0
University of Sydney
Address [1] 301235 0
92-94 Parramatta Road
Camperdown NSW 2050
Country [1] 301235 0
Australia
Funding source category [2] 301242 0
Other Collaborative groups
Name [2] 301242 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [2] 301242 0
Level 6, Chris O’Brien Lifehouse
119-143 Missenden Road, CAMPERDOWN NSW 2050
Country [2] 301242 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 300874 0
None
Name [1] 300874 0
Address [1] 300874 0
Country [1] 300874 0
Other collaborator category [1] 280436 0
Other Collaborative groups
Name [1] 280436 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [1] 280436 0
Level 6, Chris O’Brien Lifehouse
119-143 Missenden Road, CAMPERDOWN NSW 2050
Country [1] 280436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301975 0
Sydney Local Health District RPAH zone HREC
Ethics committee address [1] 301975 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 301975 0
Australia
Date submitted for ethics approval [1] 301975 0
19/11/2018
Approval date [1] 301975 0
14/02/2019
Ethics approval number [1] 301975 0

Summary
Brief summary
The purpose of the TIPS study is to compare the effectiveness of two different interventions given before surgery to see if they improve the time needed to recover after surgery. The two interventions being tested are a ‘carboloading’ drink and pain medication called pregabalin (Lyrica ®). The study aim is to reduce the time needed to recover after surgery.

Who is it for?

You may be eligible for this study if you are an adult woman who will undergo an operation for ovarian cancer.

Study details

The study involves randomly allocating participants to two different interventions. Firstly, participants are randomised to receive a carbohydrate drink (Nutricia PreOp Drink), water or no drink before surgery. The drink is to be taken 2 hours before the operation. Secondly, participants are randomised to receive pain medication capsule (pregabalin) or a placebo capsule. The capsule is given by mouth 1 hour before the operation and 12 hours after the first dose.

Following routine surgery participants will have to complete some questionnaires and answer some questions about how they're feeling, once discharged from hospital the study team will call them 30 days after discharge to ask some questions about their recovery.

It is hoped that the findings from this study may improve women having surgery for ovarian cancers comfort prior to an operation and reducing pain after the operation.
Trial website
Trial related presentations / publications
https://www.ctc.usyd.edu.au/our-research/clinical-trials/oncology/gynaecological-cancer/active-trials.aspx
Public notes

Contacts
Principal investigator
Name 88734 0
A/Prof Alison Brand
Address 88734 0
Director Gynaecological Oncology
Westmead Hospital
PO Box 533
Wentworthville
NSW 2145
Country 88734 0
Australia
Phone 88734 0
+61 2 8890 6801
Fax 88734 0
Email 88734 0
alison.brand@health.nsw.gov.au
Contact person for public queries
Name 88735 0
Dr Jason Todd
Address 88735 0
NHMRC Clinical Trials Centre
Chris O Brien Lifehouse Level 6
119–143 Missenden Road
Camperdown NSW 2050
Country 88735 0
Australia
Phone 88735 0
+61 2 9562 5000
Fax 88735 0
Email 88735 0
TIPS@ctc.usyd.edu.au
Contact person for scientific queries
Name 88736 0
Dr Jason Todd
Address 88736 0
NHMRC Clinical Trials Centre
Chris O Brien Lifehouse Level 6
119–143 Missenden Road
Camperdown NSW 2050
Country 88736 0
Australia
Phone 88736 0
+61 2 9562 5000
Fax 88736 0
Email 88736 0
TIPS@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 4227 0
Informed consent form
Citation [1] 4227 0
Link [1] 4227 0
Email [1] 4227 0
tips@ctc.usyd.edu.au
Other [1] 4227 0
Attachment [1] 4227 0
Summary results
No Results