Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women

Learn more about:
Related Clinical Trial
Doxycycline In Lymphangioleiomyomatosis (LAM) Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women Turmeric as Treatment in Epilepsy Study of the Disease Process of Lymphangioleiomyomatosis RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM The Effectiveness and Safety of Vagus Nerve Stimulation for TRE The Effectiveness and Safety of Resective Epilepsy Surgery for TRE Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) Safety of Simvastatin in LAM and TSC Studies of Autistic Patients: Gene Networks and Clinical Subtypes Topical Rapamycin to Erase Angiofibromas in TSC Rapalogues for Autism Phenotype in TSC: A Feasibility Study A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD Everolimus for Cancer With TSC1 or TSC2 Mutation Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex The Cognitive Variability in NF1 and TSC Monozygotic Twins Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC) Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1) Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy – Tuberous Sclerosis Complex A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC) Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex Characterization of Patients With Tuberous Sclerosis Complex, Lymphangioleiomyomatosis and Angiomyolipoma Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex JASPER Early Intervention for Tuberous Sclerosis Studies in Patients With Tuberous Sclerosis Complex Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM) Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex Dermatologic Patterns of Tuberous Sclerosis Patients and Somatic Mutation Relationship Genetic Heterogeneity and Genotype-phenotype Correlation of Children and Adults With Tuberous Sclerosis Complex (TuScCom) Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC) Tuberous Sclerosis Complex Natural History Study: Renal Manifestations Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) Study of Skin Tumors in Tuberous Sclerosis

Brief Title

Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women

Official Title

Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis

Brief Summary

      This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed
      from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that
      these tumors increase in size in the evening, but this result could stem from the fact that
      previous study participants were tested after eating lunch. The purpose of the study is to
      help researchers understand the factors that produce changes in size of lymphangioleiomyomas,
      as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas
      and avoid confusing these tumors with other malignant tumors.

      Volunteers must be women who are at least 18 years of age and who have been diagnosed with
      lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney
      transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a
      physical examination and medical history.

      During the study, participants will be admitted to a National Institutes of Health clinical
      center for three days to undergo a number of tests. Tests will include routine blood and
      urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic
      ultrasounds....
    

Detailed Description

      Lymphangioleiomyomatosis (LAM) is a rare disease of women that is characterized by a
      proliferation of abnormal smooth muscle-like cells (LAM cells) in the lungs, which leads to
      cystic destruction of the lung parenchyma, in the axial lymphatics, resulting in
      lymphangioleiomyomas, and in abdominal angiomyolipomas, primarily in the kidneys.
      Lymphangioleiomyomas may cause abdominal distension and compress abdominal organs, producing
      obstipation, bladder obstruction and neurological deficits. Leakage of chyle may be
      responsible for ascites and pleural effusions. The lymphangioleiomyomas may change in size
      during the day. This variation in tumor size may be due to increased chyle formation or
      alterations in lymphatic flow. These studies however, were not performed with research
      subjects who were fasting. Our hypothesis is that the ingestion of food increases chyle
      formation and lymphatic flow, which in turn increases the size of the lymphangioleiomyomas.
      The aim of this study is to test this hypothesis. We propose to conduct a study in 30 LAM
      patients who have lymphangioleiomyomas to determine whether the ingestion of food, by
      increasing chyle formation and lymphatic flow, increases the size of the
      lymphangioleiomyomas.
    


Study Type

Observational




Condition

Lymphangioleiomyomas



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

35

Start Date

October 26, 2007

Completion Date

March 21, 2016


Eligibility Criteria

        -  INCLUSION CRITERIA:

        Individuals who are 18 years of age or older with any of the following:

          1. Lymphangioleiomyomatosis

          2. Abdominal or pelvic lymphangioleiomyomas equal to or greater than one centimeter in
             diameter in the non-fasting state.

        EXCLUSION CRITERIA:

        Individuals with any of the following:

          1. Lung transplantation

          2. Kidney transplantation

          3. Lymphangioleiomyomas smaller than one centimeter in diameter in the non-fasting state.

          4. Pregnancy or lactation.

          5. Type 1 diabetes.

          6. Inability to give informed consent.

          7. Currently taking rapamycin.
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Angelo M Taveira-DaSilva, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00552955

Organization ID

080016

Secondary IDs

08-H-0016

Responsible Party

Sponsor

Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)


Study Sponsor

Angelo M Taveira-DaSilva, M.D., Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI)


Verification Date

March 21, 2016