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Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction


N/A
18 Years
65 Years
Not Enrolling
Female
Breast Cancer, Hot Flashes, Sleep Disorders

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Trial Information

Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction


OBJECTIVES:

- Compare the effect of venlafaxine or another serotonin-reuptake inhibitor with vs
without zolpidem, in terms of sleep continuity, in women with breast cancer or at high
risk for developing breast cancer who experience hot flushes and associated sleep
disorders.

- Compare quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified by concurrent use of serotonin-reuptake inhibitors (SRI).

- Stratum 1 (no concurrent SRI): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral venlafaxine once daily and oral zolpidem once daily
for 5 weeks*.

- Arm II: Patients receive oral venlafaxine once daily and oral placebo once daily
for 5 weeks*.

- Stratum 2 (concurrently on SRI): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral zolpidem once daily for 5 weeks*.

- Arm II: Patients receive oral placebo once daily for 5 weeks*. NOTE: *After 5
weeks of study treatment, patients in stratum 1 may taper or continue venlafaxine
over 2 weeks (for a total duration of venlafaxine use of 7 weeks); patients in arm
I of both strata may taper or continue zolpidem over 1 week (for a total duration
of zolpidem use of 6 weeks); continuation or tapering of drugs in both arms occurs
in an open-label fashion off study.

In both strata, treatment continues in the absence of unacceptable toxicity.

In both strata, hot flushes, sleep continuity, sleep quality, and quality of life are
assessed at baseline and at weeks 1, 3, and 6.

PROJECTED ACCRUAL: A total of 119 patients will be accrued for this study within 20 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- At increased risk of developing breast cancer, meeting 1 of the following criteria:

- Diagnosis of 1 of the following:

- Ductal carcinoma in situ

- Invasive breast cancer

- Lobular carcinoma in situ

- Atypical ductal or lobular hyperplasia

- Lobular carcinoma

- Candidate for breast cancer risk reduction for any of the following:

- Predisposing mutation in a breast cancer susceptibility gene

- Prior chest radiotherapy for Hodgkin's disease

- Gail model score > 1.67% over 5 years

- Experiencing daytime and nocturnal hot flushes at least 14 times per week within the
past 2 weeks

- Experiencing sleep disturbance, characterized by the presence of all of the following
for ≥ 1 month:

- ≥ 3 awakenings per night occurring ≥ 3 nights per week

- Insomnia impedes daytime function

- Hot flushes are the primary cause of insomnia (determined at baseline visit)

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 to 65

Sex

- Female

Menopausal status

- Not specified

Performance status

- ECOG 0-1

Life expectancy

- At least 6 months

Hematopoietic

- Not specified

Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No clinically significant cardiac disease

- No uncontrolled hypertension within the past 3 months, defined as the following:

- Diastolic blood pressure > 95 mm Hg on > 1 occasion

- Systolic blood pressure > 160 mm Hg on > 1 occasion

Pulmonary

- No clinically significant respiratory disease

Psychiatric

- Beck depression inventory score ≤ 15

- No active panic or depressive disorder within the past month

- No lifetime history of bipolar or psychotic disorder

- No active substance-use disorders, including alcohol and benzodiazepines, within the
past year

- No suicidal or homicidal ideation

- No hypomania or mania

Other

- No prior adverse reaction to venlafaxine or zolpidem

- None of the following sleep disorders within the past 6 months:

- Sleep apnea

- Narcolepsy

- Periodic limb movement disturbance

- No abuse or misuse of study medication

- No daytime sedation that interferes with ability to function

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 1 month
after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 3 months since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- More than 1 month since prior regular use (> 25% of the time) of oral, transdermal,
or injection preparations of androgens, estrogens, or progestins

- Vaginal suppositories and creams allowed

- No concurrent regular use of oral, transdermal, or injection preparations of
androgens, estrogens, or progestins

Radiotherapy

- See Disease Characteristics

- More than 3 months since prior radiotherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

Other

- More than 1 month since prior regular use (> 25% of the time) of any of the
following:

- Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or
diphenhydramine)

- Clonidine

- More than 1 month since prior antidepressants or other medications that are known to
influence mood > 25% of the time (no serotonin-reuptake inhibitors [SRI] stratum
only)

- Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the
minimum dose, including any of the following (concurrent SRI stratum only):

- Fluoxetine

- Paroxetine

- Paroxetine CR

- Sertraline

- Citalopram

- S-citalopram

- Venlafaxine

- Fluvoxamine

- No concurrent warfarin

- No concurrent hypnotic agents, clonidine, or antidepressants, or other medications
known to influence sleep, or mood

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Sleep improvement by biologic data and actigraphy data at the end of study treatment

Principal Investigator

Hadine Joffe, MD, MSC

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

CDR0000365502

NCT ID:

NCT00084669

Start Date:

May 2004

Completion Date:

March 2010

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • Sleep Disorders
  • hot flashes
  • sleep disorders
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • lobular breast carcinoma in situ
  • lobular breast carcinoma
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms
  • Sleep Disorders
  • Parasomnias
  • Hot Flashes

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617