Cancer, BreastPhase 4VAPOR-CNCT04074460
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
A Phase 4 study testing Propofol and isoflurane, sevoflurane or desflurane in people with Cancer, Breast and Cancer Colorectal, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Breast, Cancer Colorectal, Cancer Prostate
- What is being tested?
- Propofol and isoflurane, sevoflurane or desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Aug 2017to 30 Jun 2020
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18-80 years
- Elective surgery
- Major cancer surgery expecting to last two or more hours, for:
- Breast (mastectomy or segmentectomy plus sentinel node dissection)
- Colorectal
Show all 10Show fewer
- Lung
- Prostate
- Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction
- Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)
Who cannot join
- Palliative surgery for end-stage disease with no curative intent
- Emergency surgery
- Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4
- Age <18 or >80 years old
- Refusal or inability to provide valid informed consent
- Risk of severe postoperative nausea and vomiting (PONV risk score >3)
Show all 9Show fewer
- Previous allergy or contraindication to either anaesthetic medication
- Indication for gas induction of anaesthesia
- Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.
Read the detailed description
This study aims to assess the feasibility of conducting a phase IV, multi-centre, single-blinded, randomized control trial (VAPOR-C (Main)).
Primary aims To measure the ability to recruit eligible patients into the study.
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
- Conditions
- Cancer, Breast, Cancer Colorectal, Cancer Prostate, Cancer, Lung, Cancer Melanoma Skin, Cancer, Other
- Being tested
- Propofol, isoflurane, sevoflurane or desflurane
- Keywords
- major surgeries lasting >2 hours
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
General Anaesthesia
isoflurane, sevoflurane or desfluraneDrug
General Anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Propofol (TIVA) | Active comparator | Propofol-based total intravenous anaesthesia Receives: Drug: Propofol |
| Volatile | Active comparator | Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia Receives: Drug: isoflurane, sevoflurane or desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the ability to recruit eligible patients into the study.
The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved.
Measured: 18 months
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved.
Measured: 18 months
Secondary outcomes (2)
To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).
All missing data to be recorded including reason for missing data, where available. Quantitative and qualitative analysis of reasons for missing data will be analysed by : Number of fields with missing data (percentage) and reason for missing data ( qualitative descriptor). Fields with >1 missing data point will be analysed for reasons for failure.
Measured: 18 months
To test the efficiency of the centralized patient enrolment and computer randomization system.
Number of events of failed randomisation will be recorded on eCRF (under 'treatment of subjects"). Quantitative analysis of failed randomisation (reported as %) as well as descriptive reason for failure will be recorded and analysed. This will allow shortcomings in the use of the computer-generated centralised randomisation program to be identified and ratified.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start27 Aug 2017
- Primary completion31 Oct 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Melbourne Health, The Alfred
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074460
- Sponsor's protocol ID
- 16/144
- Acronym
- VAPOR-C
- Status last verified
- Jun 2022
- First submitted
- 15 Aug 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No