Screening to Predict Weight Loss in Patients With Cancer

NCT00710632 | Unknown

• 3 other identifiers: CDR0000590278QMC-WEIGHTEU-20831
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment. PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.

Conditions

Cachexia; Gastrointestinal Cancer; Hematopoietic/Lymphoid Cancer; Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

cachexia; lung cancer; gastrointestinal cancer; unspecified adult solid tumor, protocol specific; hematopoietic/lymphoid cancer

Outcome Measures

Primary Outcomes (5)

• Percentage weight loss by measuring height and weight at baseline and at 3 months

• Malnutrition Universal Screening Tool Score at initial screening

• Response to the Appetite and Symptom Questionnaire at baseline

• Level of blood C-reactive protein at baseline

• Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline

Interventions

laboratory biomarker analysis OTHER

physiologic testing OTHER

questionnaire administration OTHER

management of therapy complications PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria, depending on part of study: * Part 1: * Receiving radiotherapy for cancer at Nottingham City Hospital * Likely to be clinically stable over the duration of one week (i.e., not at high risk of disease or treatment-related appetite and weight loss) * Stable weight and appetite * Part 2: * Outpatient at Nottingham City Hospital with a confirmed diagnosis of primary lung or gastrointestinal cancer * Lost no more than 10% of pre-illness stable body weight * Lost no more than 5% of pre-illness stable body weight if body mass index (BMI) was less than 20 kg/m\^2 * BMI ≥ 18.5 kg/m\^2 PATIENT CHARACTERISTICS: * No condition impairing the ability to swallow * Not receiving enteral tube feeding or parenteral nutrition (part 2) * Able to be weighed (part 2) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent radiotherapy to the head, neck or upper gastrointestinal tract area

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (1)

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Cachexia; Gastrointestinal Neoplasms; Hematologic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vanessa Halliday, MSC

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 4, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Last Updated: September 17, 2013

Record last verified: 2009-07

Locations

GB (1)