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Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Sexual Dysfunction, Sexuality and Reproductive Issues

Thank you

Trial Information

Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study


OBJECTIVES:

Primary

- Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal
dryness in patients with breast cancer.

Secondary

- Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.

- Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs > 65), concurrent
tamoxifen therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), concurrent
aromatase inhibitor therapy (yes vs no vs unknown [e.g., on a blinded clinical study]), and
perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe).
Patients are randomized to 1 of 4 treatment arms.

- Arm I: Patients receive oral pilocarpine hydrochloride once a day for 3 days, twice a
day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks
in the absence of unacceptable toxicity.

- Arm II: Patients receive oral pilocarpine hydrochloride once a day for 3 days and then
twice a day for up to 6 weeks in the absence of unacceptable toxicity.

- Arm III: Patients receive oral placebo once a day for 3 days, twice a day for 3 days,
three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence
of unacceptable toxicity.

- Arm IV: Patients receive oral placebo once a day for 3 days and then twice a day for up
to 6 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and then weekly for 6 weeks.

PROJECTED ACCRUAL: A total of 192 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- History of breast cancer (currently no evidence of disease)

- Unwilling to take vaginal estrogen due to fear of an increased risk of breast
cancer

- Significant vaginal complaints, defined as persistent vaginal dryness and/or itching
of sufficient severity to make a patient desire therapeutic intervention

- Symptoms present ≥ 2 months prior to randomization

- No active vaginal infection

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Postmenopausal or no childbearing potential

- Life expectancy > 6 months

- SGOT < 1.5 times upper limit of normal (ULN) for the past year

- Creatinine ≤ 1.5 times ULN for the past year

- Able to complete questionnaire(s) alone or with assistance

- No diagnosis of any of the following:

- Asthma

- Chronic obstructive pulmonary disease

- Coronary artery disease

- Narrow angle glaucoma

- Known cholelithiasis

- Vulvar and vaginal dysplasia

- Essential vulvodynia

- Vulvar vestibulitis

- Vaginal prolapse

- Bartholin cyst/abscess

- Lichen sclerosis

- Lichen planus of the vulvovaginal region

- Desquamative vaginitis

- No known history of cardiac arrhythmia

- No history of Bartholin gland surgery

- No acute iritis

PRIOR CONCURRENT THERAPY:

- No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months
prior to study randomization or plans to initiate or discontinue any of these
medications during the 6-week study period

- More than 1 week since prior vaginal preparations*

- If patient has used vaginal preparations during the previous week but is
planning to stop, then the patient may enter the study with plans to start with
pretreatment questionnaire 1 week later NOTE: *Lubricants used during sexual
intercourse are allowed

- No prior radical pelvic surgery

- Total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO)
allowed

- No prior pilocarpine hydrochloride

- No prior or concurrent pelvic radiotherapy

- More than 4 weeks since prior and no concurrent estrogen products

- No concurrent vaginal preparations (including any over-the-counter or herbal
preparations)

- No other concurrent anticholinergics

- No concurrent chemotherapy

- No concurrent hormonal therapy, including progestationally-coated intrauterine
devices (IUDs)

- No concurrent pharmacologic soy preparations

- No concurrent surgery and/or radiotherapy for recurrent cancer

- No beta adrenergic antagonists

- No other concurrent treatment for vaginal dryness

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000482969

NCT ID:

NCT00343382

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • sexuality and reproductive issues
  • sexual dysfunction
  • 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
  • Sexual Dysfunctions, Psychological

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Alexandria, Minnesota  56308
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Mercy Medical Center Springfield, Ohio  45504
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Adventist Medical Center Portland, Oregon  97216
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
OSF Holy Family Medical Center Monmouth, Illinois  61462
Mercy General Health Partners Muskegon, Michigan  49443
AnMed Cancer Center Anderson, South Carolina  29621
Immanuel St. Joseph's Mankato, Minnesota  56002
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935