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| Sponsored by: |
Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00228943 |
Purpose
The purpose of this proposal is to improve our understanding of the role of tryptophan and serotonin in hot flashes. The main hypothesis is that alterations in tryptophan and serotonin levels are involved in the induction of hot flashes in women with breast cancer and genetic variations in the serotonin receptors and transporters also play a role.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Dietary Supplement: Acute tryptophan depletion Dietary Supplement: Half-strength tryptophan depletion (Control) |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | The Role of Serotonin in Hot Flashes After Breast Cancer |
| Enrollment: | 28 |
| Study Start Date: | July 2005 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Acute tryptophan depletion: Experimental
Full-strength tryptophan depletion
|
Dietary Supplement: Acute tryptophan depletion
L-alanine (5.5g), L-arginine (4.9g), L-cysteine (2.7g), glycine (3.2g), L-histidine (3.2g), L-isoleucine (8.0g), L-leucine (13.5g), L-lysine (11.0g), L-methionine (3.0g), L-phenylalanine (5.7g), L-proline (12.2g), L-serine (6.9g), L-threonine (6.9g), L-tyrosine (6.9g), L-valine (8.9g)
|
|
Control: Active Comparator
Half-strength tryptophan depletion drink used as a control
|
Dietary Supplement: Half-strength tryptophan depletion (Control)
L-alanine (1.4g), L-arginine (1.2g), L-cysteine (0.7g), glycine (0.8g), L-histidine (0.8g), L-isoleucine (2.0g), L-leucine (3.4g), L-lysine (2.8g), L-methionine (0.8g), L-phenylalanine (1.4g), L-proline (3.1g), L-serine (1.7g), L-threonine (1.7g), L-tyrosine (1.7g), L-valine (2.2g), and fillers (7.95g).
|
Among women with breast cancer, hot flashes are a frequent, severe and bothersome symptom. For this group, hot flashes are negatively related to mood, affect, and daily activities and can compromise compliance with life-saving medications (e.g., tamoxifen). Over 60% of breast cancer survivors report hot flashes, with 59% stating they are extremely severe and 44% reporting them to be extremely bothersome. Unfortunately, limitations in our understanding of hot flash physiology limit clinicians' abilities to fully treat this symptom. Although the current non-hormonal treatment of choice for hot flashes after breast cancer targets the central serotonin system (e.g., paroxetine, venlafaxine), the role of serotonin in hot flashes has not been directly tested.
Because the effectiveness of these agents has been based largely on improvement in subjective reporting of hot flashes, it is not clear whether benefits are due to physiological effects on hot flashes or due to improvements in mood or other related symptoms. In addition, these and other currently available treatments are not acceptable, appropriate, or effective for all women with breast cancer. Understanding the physiological mechanisms involved in hot flashes after breast cancer will enable us to develop more targeted behavioral and/or pharmacological therapies to be used in lieu of, or in addition to, currently available therapies so that we can eradicate hot flashes and improve the quality of life for women with breast cancer.
Results implicating direct effects of tryptophan and serotonin on objective hot flashes will help guide the development of improved interventions for alleviating hot flashes in women with breast cancer. These interventions may target the central serotonin system either behaviorally (e.g., diet) or pharmacologically (e.g., alternative drug therapeutics). If direct manipulation of tryptophan and serotonin does not affect hot flashes, these findings will be equally as useful in guiding future research on non-serotonin related etiologies and interventions. Findings from this study will ultimately be used to eradicate hot flashes as a frequent, severe and bothersome breast cancer treatment related condition, thereby, improving quality of life for all women with breast cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Janet S Carpenter, PhD | Indiana University School of Medicine |
More Information
| Responsible Party: | Indiana University School of Nursing ( Janet Carpenter, PhD, RN ) |
| Study ID Numbers: | 0501-03, DOD-BC043199, 043199 |
| Study First Received: | September 14, 2005 |
| Results First Received: | November 13, 2008 |
| Last Updated: | April 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00228943 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Breast cancer survivorship Hot Flashes Serotonin |
|
Tryptophan Proline Neurotransmitter Agents Alanine Skin Diseases Arginine Glycine Hot Flashes Psychotropic Drugs Lysine Tyrosine Breast Neoplasms |
Phenylalanine Methionine Serotonin Signs and Symptoms Cysteine Histidine Leucine Antidepressive Agents, Second-Generation Serine Breast Diseases Antidepressive Agents |
|
Tryptophan Neurotransmitter Agents Skin Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Hot Flashes Breast Neoplasms Serotonin Pharmacologic Actions |
Signs and Symptoms Neoplasms Neoplasms by Site Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents Breast Diseases |
