Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-11 @ 9:04 PM
Study NCT ID:
NCT00486304
Status:
COMPLETED
Last Update Posted:
2012-04-18
First Post:
2007-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2007-06-13', 'studyFirstSubmitQcDate': '2007-06-13', 'lastUpdatePostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of people with adverse events', 'timeFrame': '70 days', 'description': 'Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cachexia', 'weight changes', 'recurrent oropharyngeal cancer', 'stage I oropharyngeal cancer', 'stage II oropharyngeal cancer', 'stage III oropharyngeal cancer', 'stage IV oropharyngeal cancer'], 'conditions': ['Cachexia', 'Head and Neck Cancer', 'Weight Changes']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer.\n\nPURPOSE: This randomized phase I trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety of the antioxidant-deficient diet (ADD) in controlling cachexia in patients with oropharyngeal cancer receiving chemoradiotherapy.\n\nSecondary\n\n* Determine the safety of the ADD as measured by quality of life, peripheral DNA damage, and change in body weight.\n* Determine the effectiveness of the ADD on tumor growth and surrogate markers of tumor growth.\n* Determine whether the ADD is effective in improving the tumor cachexia syndrome in these patients.\n* Determine whether there is a serum metabolomic signature for the ADD.\n\nOUTLINE: This a prospective, randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients consume a standard diet 3 times a day for 8 weeks.\n* Arm II: Patients consume an antioxidant-deficient diet (ADD) 3 times a day for 8 weeks. Patients receive replacement vitamins in week 9.\n\nAll patients receive planned chemoradiotherapy in weeks 3-8.\n\nQuality of life, body composition (by dual-energy x-ray absorptiometry), weight, and resting energy expenditure (by indirect calorimetry) are assessed at baseline and at week 8.\n\nBlood samples are collected at baseline and at 8 weeks. Samples are evaluated for cytokine levels; evidence of DNA damage from peripheral blood lymphocytes; and serum signature characteristic to ADD by multinuclear MRI spectroscopy. Patients undergo a tumor biopsy in week 4 for research studies. Samples are collected and evaluated for generation of reactive oxygen species by using antibodies against oxidatively modified DNA and lipids; apoptosis using TdT-mediated dUTP nick-end labeling assay and classical morphological criteria; and levels of the tumor toxohormones lipid mobilizing factor and proteolysis inducing factor by real time-PCR, northern blotting, and western blotting methods.\n\nAfter completion of study therapy, patients are followed once during weeks 9-12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Biopsy-proven carcinoma of the oropharynx (regardless of primary diagnosis or recurrence)\n* No active treatment for disease within the past 4 weeks\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Feeding tubes allowed\n* Prior malignancies allowed provided all of the following criteria are met:\n\n * Patient has undergone potentially curative therapy for all prior malignancies\n * There has been no evidence of any prior malignancies within the past 5 years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrences)\n * Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies\n* Must be able to speak English\n* Must have adequate home refrigeration\n* No intractable vomiting\n* No ascites or clinical/ultrasound evidence of fluid retention\n* No uncontrolled hypertension\n* No severe congestive heart failure\n* No pneumonia\n* No severe infections\n* No known HIV positivity\n* No coexisting medical condition that would preclude study compliance\n* No decisionally-impaired individuals\n* No history of abetalipoproteinemia (Bassen-Kornzweig syndrome)\n* No history of spinocerebellar ataxia\n* No history of chronic cholestatic hepatobiliary disease\n* No history of diagnosed vitamin E deficiency\n* No history of protein-energy malnutrition (marasmus or kwashiorkor)\n* No history of disorders related to malabsorption (e.g., celiac disease, sprue, cystic fibrosis, duodenal bypass, congenital partial obstruction of the jejunum, obstruction of the bile ducts, giardiasis, or cirrhosis)\n* No history of achlorhydria\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT00486304', 'briefTitle': 'Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Phase I Randomized, Double-blind, Placebo-controlled Trial of the Effect of Temporary Dietary Antioxidant Depletion on Tumor Growth and Cachexia in Head and Neck Cancer Patients Receiving Chemoradiation Therapy', 'orgStudyIdInfo': {'id': 'LCCC 0523'}, 'secondaryIdInfos': [{'id': 'CDR0000549772', 'type': 'OTHER', 'domain': 'PDQ number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antioxidant-deficient diet (ADD)', 'interventionNames': ['Other: ADD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ADD', 'type': 'OTHER', 'description': 'The ADD has a composition of 65% carbohydrate, 20% fat, and 15% protein. The diet will be completely depleted of vitamins A, E and beta-carotene; it will have 10 mg of vitamin C (6.5% of RDA) added per person per day', 'armGroupLabels': ['Antioxidant-deficient diet (ADD)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Jevity 1.5 (1.5 cal/mL) will be used for the placebo patients in this study. This will simulate the standard of care for patients not on the ADD. Jevity 1.5 is an isotonic, fiber-fortified, high-nitrogen liquid formula providing complete, balanced nutrition for patients requiring short- or long-term tube feeding, given once per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Marion Couch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}