Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00710632
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2008-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening to Predict Weight Loss in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2008-07-03', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage weight loss by measuring height and weight at baseline and at 3 months'}, {'measure': 'Malnutrition Universal Screening Tool Score at initial screening'}, {'measure': 'Response to the Appetite and Symptom Questionnaire at baseline'}, {'measure': 'Level of blood C-reactive protein at baseline'}, {'measure': 'Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline'}]}, 'conditionsModule': {'keywords': ['cachexia', 'lung cancer', 'gastrointestinal cancer', 'unspecified adult solid tumor, protocol specific', 'hematopoietic/lymphoid cancer'], 'conditions': ['Cachexia', 'Gastrointestinal Cancer', 'Hematopoietic/Lymphoid Cancer', 'Lung Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment.\n\nPURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To identify people with cancer who are at greatest risk of future weight loss by the development of a simple and practical screening tool.\n* To estimate the reliability of the Appetite and Symptom Questionnaire (part 1).\n* To develop a screening tool based on the ability of the optimal combination of items from the three measures (ASQ, MUST, CRP) to predict clinically significant weight loss over three months (part 2).\n* To estimate the sensitivity and specificity at various cut-points of the developed screening tool in predicting clinically significant weight loss (\\> 10% weight loss or between 5% and 10% weight loss with a BMI \\< 20 kg/m\\^2) over three months (part 2).\n\nOUTLINE: This is a two-part study.\n\n* Part 1: Patients are asked to complete the Appetite and Symptom Questionnaire (ASQ) on two occasions, one week apart.\n* Part 2: Patients are screened at baseline for risk of malnutrition using the Malnutrition Universal Screening Tool. Blood samples are also taken at this time to establish the level of C-reactive protein and patients complete the ASQ. Patients are weighed using calibrated scales and height measurements are obtained. Patients are asked about unplanned weight loss over the previous 3-6 months. Patients are weighed again at 3 months. Percentage weight loss is calculated at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria, depending on part of study:\n\n * Part 1:\n\n * Receiving radiotherapy for cancer at Nottingham City Hospital\n * 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)\n * Stable weight and appetite\n * Part 2:\n\n * Outpatient at Nottingham City Hospital with a confirmed diagnosis of primary lung or gastrointestinal cancer\n * Lost no more than 10% of pre-illness stable body weight\n * Lost no more than 5% of pre-illness stable body weight if body mass index (BMI) was less than 20 kg/m\\^2\n * BMI ≥ 18.5 kg/m\\^2\n\nPATIENT CHARACTERISTICS:\n\n* No condition impairing the ability to swallow\n* Not receiving enteral tube feeding or parenteral nutrition (part 2)\n* Able to be weighed (part 2)\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent radiotherapy to the head, neck or upper gastrointestinal tract area'}, 'identificationModule': {'nctId': 'NCT00710632', 'briefTitle': 'Screening to Predict Weight Loss in Patients With Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Predicting Weight Loss in People With Cancer: Development of a Screening Tool', 'orgStudyIdInfo': {'id': 'CDR0000590278'}, 'secondaryIdInfos': [{'id': 'QMC-WEIGHT'}, {'id': 'EU-20831'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'physiologic testing', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Vanessa Halliday, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's Medical Center", 'class': 'OTHER'}}}}