Condition category
Cancer
Date applied
28/11/2016
Date assigned
19/12/2016
Last edited
16/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Mrs Amy Kerr

ORCID ID

Contact details

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-
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United Kingdom
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amy.kerr@heartofengland.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31591

Study information

Scientific title

Adults undergoing major lung surgery randomised to nutritional intervention or equivalent volume in water to assess the effects on post-operative outcomes

Acronym

ThIRStY

Study hypothesis

The aim of this study is to assess the feasibility of carrying out a randomised controlled trial comparing the effectiveness of a nutritional intervention (NI) of preoperative carbohydrate-loading drinks and early postoperative nutritional supplement drinks compared to receiving an equivalent volume of water in enhancing recovery after major lung surgery (MLS)

Ethics approval

WALES REC 7, 05/09/2016, ref: 16/WA/0254

Study design

Randomised; Both; Design type: Prevention, Dietary, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

Intervention

After written informed consent, the patient will be randomised, before surgery, to either a nutritional intervention or water. Participants will be individually randomised into the study in an equal 1:1 ratio. Randomisation will be by a web based randomisation system. Patients will be stratified by diagnosis (cancer or benign) and type of surgery (key hole or open).

The nutritional intervention in brief the evening before surgery 4x200mls, the morning of surgery, 2X200mls of carbohydrate-loading supplement will be given. In the postoperative period patients will be given 125ml polymeric nutritional supplement drink twice a day from the period immediately after their operation for 2 weeks. The control group will consume the same quantity of water thus any benefit from the intervention will not be due to preventing dehydration.

Follow up will be 3 months post-surgery with Visual Analogue Score (VAS), Quality of Recovery and EQ5D questionnaires.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Recruitment rate is recorded as the number of eligible participant who consent to participate in the study by 12 months.

Secondary outcome measures

1. Reasons for failure to recruit are assessed by screening log at the end of the study
2. Ease and efficiency of randomisation process is assessed by speed in which patients can be randomised and whether important prognostic data can be collected pre-operatively at the end of the study
3. Compliance rate of the intervention and contamination rate of the control group is assessed by data gathered by questionnaire and interview, we would expect to have a compliance of 50% of prescribed carbohydrate drinks and ONS taken as scheduled by the end of recruitment
4. Robustness of data collection processes during patient’s hospital stay is assessed by completeness of important peri-operative data to be over 90% for each patient.
5. Follow-up rate of patients at 3 months is assessed by a response rate of 80% at 3 months
6. Reasons for loss of follow-up (if any) are measured at 3 months,100% of mortality data will be captured.
7. Questionnaire best reflects patient experience is assessed by patient interviews at 3-4 week post-surgery.
8. Variability and distribution of quality of life questionnaires measured by return rate up to 3 months after surgery

Overall trial start date

16/06/2016

Overall trial end date

21/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients, aged over 18
2. Undergoing elective major lung surgery (MLS)
3. Able to consume nutritional drinks prior to surgery
4. Able to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Likely inability to comply with completion of the study questionnaires
2. Body mass index (BMI) < 18.5 kg/m2
3. Receiving enteral nutrition
4. Known pregnancy

Recruitment start date

22/09/2016

Recruitment end date

21/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heartlands Hospital
Bordsley green
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Heart of England NHS Foundation Trust

Sponsor details

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom
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1@1

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Heart of England NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This feasibility study is designed to identify if a substantive trial is possible. Although a definitive answer to the key research question on effectiveness of nutritional intervention in patient undergoing major thoracic surgery cannot be provided, the findings of this feasibility study will be of scientific interest to others in their own right. The dissemination strategy has been planned in three aspects. The first will ensure that patients and health professionals are informed of the feasibility findings; the second will engage multi-disciplinary professionals to support a proposal of a definitive RCT and the third will be to submit a grant application dependant on the success of the feasibility study (2018).

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2017 Cancer Help UK lay summary link added.