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


N/A
18 Years
80 Years
Not Enrolling
Female
Lymphangioleiomyomas, Tuberous Sclerosis, Lymphangioleiomyomatosis

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Angelo M Taveira-DaSilva, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

080016

NCT ID:

NCT00552955

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Lymphangioleiomyomas
  • Tuberous Sclerosis
  • Lymphangioleiomyomatosis
  • Lymphangioleiomyomatosis
  • Abdominal Lymphangioleiomyomas
  • Chyle
  • Ascites
  • Tuberous Sclerosis Complex
  • LAM
  • Lymphangiomyoma
  • Sclerosis
  • Tuberous Sclerosis
  • Lymphangioleiomyomatosis

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892