Project Crane

CRANE: Feasibility of a cluster randomised study of a nutritional intervention to improve outcomes after cancer surgery in low-income countries.

CRANE is a feasibility study funded by the UK Medical Research Council.:

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COUNTRIES

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HOSPITALS

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PATIENTS RECRUITED

Background

Following GlobalSurg 3, our international cohort study examining surgical outcomes for cancer patients, CRANE will be the first high quality global trial of a nutritional supplement given to malnourished patients prior to cancer surgery in low & middle income countries.

It is estimated that two-thirds of patients undergoing cancer surgery in low- and middle-income countries (LMICs) are malnourished. Increasingly it is being recognised that boosting the health of patients before surgery can greatly improve the chances of a successful operation. The CRANE Study will be investigating the benefit of intensively treating patients in LMICs with nutritional supplements prior to surgery.

Aims & Objectives

Primary Objective

Objective 1: to identify and validate a nutritional screening tool relevant to patients in LMICs

Objective 2: to identify a low cost sustainable nutritional intervention for cancer surgery patients in LMICs

Objective 3: to test the feasibility of patient recruitment, retention & nutritionational supplement acceptability

For many types of cancer, high quality surgery is the only cure. This is particularly true in low-income countries where treatments such as chemotherapy or radiotherapy may not be available.

Malnutrition is a major public health issue in LMICs, with as many as two-thirds of hospitalised adults being malnourished. Cancer often causes extreme weight loss and, in many countries, this occurs on top of pre-existing malnutrition. Malnutrition is associated with higher post-operative mortality and morbidity, including longer length of inpatient stay and increased healthcare-associated costs.

It has been demonstrated that perioperative nutrition in patients undergoing gastrointestinal cancer surgery can halve postoperative complications, reduce post-operative stay and significantly impact on surgery-associated mortality. Nutritional supplementation provided at the time of surgery in LMICs could provide a low cost and sustainable intervention, requiring minimal specialist training and equipment to administer.

GlobalSurg 3 is providing data that will allow us to establish the relationship between malnutrition and surgical outcomes in a way that hasn’t been possible previously, but to find a solution to the problem we need a large scale trial testing nutritional interventions prior to surgery.

The CRANE trial is a feasibility study designed to bridge the gap between the GlobalSurg 3 observational study and a large scale clinical trial.

Systematic reviews and guided focus groups will be used to establish a suitable malnutrition screening tool and to identifying the most appropriate nutritional intervention to deliver, including patient acceptability.

A pilot trial will investigate whether patient recruitment and retention is achievable in a trial of this nature, and test methods of data collection.

Establishing all of these things in a feasibility study will inform the design of a large scale cluster randomised controlled trial in the future.

Adults undergoing surgery for gastrointestinal and breast cancer at 20 hospital in Ghana, Pakistan, Philippines and Zambia

CRANE is a cluster randomised trial; it is randomised at the level of the institution, rather than at patient level.