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A multicentre randomised controlled trial of nutritional intervention for patients with weight loss who are undergoing chemotherapy for gastrointestinal (GI) Malignancy, Non Small Cell Lung cancer (NSCL) or Mesothelioma

A multicentre randomised controlled trial of nutritional intervention for patients with weight loss who are undergoing chemotherapy for gastrointestinal (GI) Malignancy, Non Small Cell Lung cancer (NSCL) or Mesothelioma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86266498
Enrollment
660
Registered
2003-09-12
Start date
2002-11-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Gastrointestinal Cancer Gastrointestinal

Interventions

1. Dietary advice to increase food intake by 600 calories 2. Dietary advice to increase intake by 600 calories plus oral supplement drink providing 588 calories plus mineral and vitamin supplement 3.

Sponsors

Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have agreed to undergo chemotherapy for histologically proven metastatic or locally advanced tumours in the gastrointestinal tract who are fit for chemotherapy and have weight loss defined by at least one of the following criteria: Body Mass Index <20 kg/m^2, weight loss of 55 or more over 3 months or greater, body weight of 5% or more below ideal body weight.

Exclusion criteria

Exclusion criteria: Clinical condition precluding oral nutrition, unable to tolerate milk, being considered for immediate enteral or parenteral nutrition.

Design outcomes

Primary

MeasureTime frame
Survival benefit related to nutritional intervention. Dietary advice to improve nutritional intake results in weight gain.

Secondary

MeasureTime frame
Any additional benefits when nutritional supplements are given with dietary advice.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026