Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01005108
First received: October 29, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. The investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (HFs).


Condition Intervention Phase
Hot Flashes
Drug: Gabapentin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Daily Hot Flash Diary (DHFD)-Primary Outcome (2 minutes per day) [ Time Frame: Daily starting from baseline until week 12 and again for one week at week 24. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographics -Covariates [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Hot Flash Related Daily Interference Scale (HFRDIS)-Secondary outcome [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) - Secondary outcome [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
  • Brief Fatigue Inventory (BFI) - Secondary Outcome [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
  • HADS - Secondary Outcome [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
  • Global Assessment Scale -Secondary Outcome [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
  • Acupuncture Expectancy Scale (AES) - Secondary Aim [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
  • Creditability Rating of Acupuncture - Secondary Aim [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
  • Medication and CAM Usage -Covariates [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Actigraph Movement Measuring Device [ Time Frame: 24 hrs/day for 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: January 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gabapentin
    Use of Gabapentin as a control intervention to evaluate the relative effects and adverse events of acupuncture for hot flashes
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women 18 years or older with a history of Stage I, II or III breast cancer for at least 12 months.
  2. Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history;
  3. Experienced at least two hot flashes daily over the seven-day screening period as based on the Daily Hot Flash Diary.
  4. Hot flashes have been present for at least a month before study entry.
  5. Willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal.

Exclusion Criteria:

  1. Having metastatic breast cancer ( IV)
  2. Currently on chemotherapy or radiation therapy as adjuvant treatment
  3. Started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks.
  4. Started or changed with treatments for hot flashes, such as SSRIs or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks.
  5. Current use of estrogen and/or progestin.
  6. Pregnancy
  7. Breast feeding
  8. Bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles.
  9. Previous use of gabapentin for hot flashes.
  10. Current use of any anti-convulsant.
  11. Renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal
  12. Known allergy to gabapentin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005108

Locations
United States, Pennsylvania
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Jun J Mao, MD, MSCE Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jun James Mao, MD, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01005108     History of Changes
Other Study ID Numbers: UPCC 16108, NCI-2009-01315
Study First Received: October 29, 2009
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Hot Flashes for Breast Cancer Patients

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on August 20, 2014