Study Type:
Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo
Control, Parallel Assignment, Efficacy Study
Official Title: Pycnogenol for
the Treatment of Lymphedema of the Arm in Breast Cancer
Survivors
Further study details as provided by National Center for
Complementary and Alternative Medicine
(NCCAM):
Estimated Enrollment: 26
Study Start Date:
August 2003
Study Completion Date: August 2007
Primary Completion Date:
August 2007 (Final data collection date for primary outcome
measure)
Detailed Description:
Lymphedema of the arm affects the function
and self-image of approximately 600,000 of the 2 million breast
cancer survivors in the United States. Chronic lymphedema can lead to
recurrent infections and permanent
swelling, in some cases
impairing function. Although various methods of massage and the use of
non-elastic
compression "sleeves" have been shown to decrease the
severity of lymphedema, these methods of physical
therapy are
limited in terms of patient acceptance, compliance, and by the availability of
trained therapists.
There is presently no pharmacologic treatment
that has proven effective in treating or preventing the
development
of lymphedema in women treated for breast cancer. This is a double-blind,
placebo-controlled
trial of an extract of the bark of the French
maritime pine tree (Pycnogenol(r)) as a treatment for arm
lymphedema in breast cancer survivors. Pycnogenol(r) is widely used in
Europe for lymphedema of the leg
and varicose veins, and is thought
to act by several mechanisms including vascular permeability and vascular
constriction. The development of such a therapeutic approach would
therefore constitute a major
breakthrough in the treatment of this
common symptom of breast cancer lymphedema. Bioelectric
impedance
is a painless, quick, and easily-performed method of estimating the
extracellular and total water
volume of the body or segment, such as
the arm. We will compare the correlation of both a single- and a
multiple-frequency bioelectric impedance instrument in measuring change
in arm volume to a standard
assessment using water displacement. We
expect that bioelectric impedance will prove faster and more
sensitive to changes in extracellular water (lymphedema) than the water
displacement method. We also
propose to use a small oral dose of
midazolam and single blood sampling to screen for effects of
Pycnogenol(r) on the activity of the common drug metabolizing enzyme
CYP3A4. For those subjects who
are already receiving digoxin, we
will use digoxin urine excretion to screen for effects of the botanical upon
the activity of P-glycoprotein. Finally, we will continue the
evaluation of a new questionnaire of lymphedema
symptoms presently
being tested as a tool for assessing the severity and improvement of symptoms
with
treatment. In summary, the successful completion of this
research can be expected to provide an alternative
therapy and new
instruments for treating and measuring lymphedema.
Criteria
Inclusion
criteria:
Unilateral (ipsilateral to breast cancer resection side)
lymphedema of the upper extremity.
Extravascular water ration of > 1.07/1
between affected vs. normal arm using multiple frequency bioelectric
impedence
Patient
is > 2months from last surgical or radiation treatment to the affected
axilla
Renal and hepatic function:
Creatinine clearance > 50ml/min,
total bili <2 mg/dl, transaminases <1.5 x ULN
Patient not pregnant
or breastfeeding. Use of barrier contraception if sexually active.
ECOG
performance of 0-2
Patient not allergic to pycnogenol
Exclusion
criteria:
Patients treated with their first course of chemotherapy or
radiation
Chemotherapy or radiation to axillary lymph node will exclude
patients for 8 weeks following treatment
Patients with more than one episode
of arm cellulitis, venous clot, or woody fibrosis of the affected arm.
Antibiotics used to treat cellulitis must be completed at least 4 weeks
prior to initial screening
Patients with a defibrillator Midazolam study
only: Patients requiring or benefiting from supplemental oxygen,
patients allergic to cherries
Contacts and Locations
Please
refer to this study by its ClinicalTrials.gov identifier:
NCT00064857
Locations
United States, Wisconsin
University of
Wisconsin Comprehensive Cancer Center and School of Pharmacy
Madison,
Wisconsin, United States, 53706
Sponsors and Collaborators
National
Center for Complementary and Alternative Medicine
(NCCAM)
Investigators
Study Chair: James F. Cleary, M.B.B.S. University
of Wisconsin, Madison
More Information
No publications
provided
Study ID Numbers: R21 AT001724-01
Study First Received: July
14, 2003
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier:
NCT00064857 History of Changes
Health Authority: United States:
Federal Government; United States: Food and Drug
Administration
------------------------------------
Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo
Control, Parallel Assignment, Efficacy Study
Official Title: Pycnogenol for
the Treatment of Lymphedema of the Arm in Breast Cancer
Survivors
Further study details as provided by National Center for
Complementary and Alternative Medicine
(NCCAM):
Estimated Enrollment: 26
Study Start Date:
August 2003
Study Completion Date: August 2007
Primary Completion Date:
August 2007 (Final data collection date for primary outcome
measure)
Detailed Description:
Lymphedema of the arm affects the function
and self-image of approximately 600,000 of the 2 million breast
cancer survivors in the United States. Chronic lymphedema can lead to
recurrent infections and permanent
swelling, in some cases
impairing function. Although various methods of massage and the use of
non-elastic
compression "sleeves" have been shown to decrease the
severity of lymphedema, these methods of physical
therapy are
limited in terms of patient acceptance, compliance, and by the availability of
trained therapists.
There is presently no pharmacologic treatment
that has proven effective in treating or preventing the
development
of lymphedema in women treated for breast cancer. This is a double-blind,
placebo-controlled
trial of an extract of the bark of the French
maritime pine tree (Pycnogenol(r)) as a treatment for arm
lymphedema in breast cancer survivors. Pycnogenol(r) is widely used in
Europe for lymphedema of the leg
and varicose veins, and is thought
to act by several mechanisms including vascular permeability and vascular
constriction. The development of such a therapeutic approach would
therefore constitute a major
breakthrough in the treatment of this
common symptom of breast cancer lymphedema. Bioelectric
impedance
is a painless, quick, and easily-performed method of estimating the
extracellular and total water
volume of the body or segment, such as
the arm. We will compare the correlation of both a single- and a
multiple-frequency bioelectric impedance instrument in measuring change
in arm volume to a standard
assessment using water displacement. We
expect that bioelectric impedance will prove faster and more
sensitive to changes in extracellular water (lymphedema) than the water
displacement method. We also
propose to use a small oral dose of
midazolam and single blood sampling to screen for effects of
Pycnogenol(r) on the activity of the common drug metabolizing enzyme
CYP3A4. For those subjects who
are already receiving digoxin, we
will use digoxin urine excretion to screen for effects of the botanical upon
the activity of P-glycoprotein. Finally, we will continue the
evaluation of a new questionnaire of lymphedema
symptoms presently
being tested as a tool for assessing the severity and improvement of symptoms
with
treatment. In summary, the successful completion of this
research can be expected to provide an alternative
therapy and new
instruments for treating and measuring lymphedema.
Criteria
Inclusion
criteria:
Unilateral (ipsilateral to breast cancer resection side)
lymphedema of the upper extremity.
Extravascular water ration of > 1.07/1
between affected vs. normal arm using multiple frequency bioelectric
impedence
Patient
is > 2months from last surgical or radiation treatment to the affected
axilla
Renal and hepatic function:
Creatinine clearance > 50ml/min,
total bili <2 mg/dl, transaminases <1.5 x ULN
Patient not pregnant
or breastfeeding. Use of barrier contraception if sexually active.
ECOG
performance of 0-2
Patient not allergic to pycnogenol
Exclusion
criteria:
Patients treated with their first course of chemotherapy or
radiation
Chemotherapy or radiation to axillary lymph node will exclude
patients for 8 weeks following treatment
Patients with more than one episode
of arm cellulitis, venous clot, or woody fibrosis of the affected arm.
Antibiotics used to treat cellulitis must be completed at least 4 weeks
prior to initial screening
Patients with a defibrillator Midazolam study
only: Patients requiring or benefiting from supplemental oxygen,
patients allergic to cherries
Contacts and Locations
Please
refer to this study by its ClinicalTrials.gov identifier:
NCT00064857
Locations
United States, Wisconsin
University of
Wisconsin Comprehensive Cancer Center and School of Pharmacy
Madison,
Wisconsin, United States, 53706
Sponsors and Collaborators
National
Center for Complementary and Alternative Medicine
(NCCAM)
Investigators
Study Chair: James F. Cleary, M.B.B.S. University
of Wisconsin, Madison
More Information
No publications
provided
Study ID Numbers: R21 AT001724-01
Study First Received: July
14, 2003
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier:
NCT00064857 History of Changes
Health Authority: United States:
Federal Government; United States: Food and Drug
Administration
------------------------------------