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Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?


Phase 3
N/A
N/A
Open (Enrolling)
Female
Cognitive/Functional Effects, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer, Weight Changes

Thank you

Trial Information

Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?


OBJECTIVES:

Primary

- To determine if patients who are disease-free after successfully completing primary and
potential consolidation/maintenance therapy for stage II, III, or IV ovarian
epithelial, fallopian tube, or primary peritoneal cancer and who are randomized to a
healthy lifestyle intervention, will have significantly increased progression-free
survival when compared with similar patients who are randomized to usual care.

Secondary

- To determine if patients who are randomized to the study intervention will have
improved general quality of life as measured by the General Health subscale of RAND-36
and physical functioning as measured by the Physical Functioning subscale of RAND-36
and the GSRS-IBS when compared with women who are randomized to usual care.

Tertiary (Exploratory)

- To perform a pilot assessment at baseline and at 6-, 12-, and 24-month dietary
biomarkers in a sub-sample of the study population to estimate compliance with the
healthy lifestyle intervention and to explore the relationship between carotenoid
exposure and progression-free survival from ovarian cancer.

- To examine patient compliance with the healthy lifestyle intervention and to assess
which types of patients are more likely to be compliant with the healthy lifestyle
intervention and whether progression-free survival is better among compliant
individuals.

- To explore the impact of the intervention on other aspects of quality of life such as:
pain, role limitations due to physical health and emotional problems, mental health,
vitality, and social functioning as measured by the corresponding subscales of the
RAND-36.

- To explore the impact of the intervention on bowel functioning as measured with the
GSRS-IBS subscales.

OUTLINE: This is a multicenter study. Participants are stratified according to stage of
disease at diagnosis (II vs III vs IV) and presence or absence of maintenance/consolidation
therapy following primary treatment. Participants are randomized to 1 of 2 groups.

- Group 1 (lifestyle intervention): Participants receive a dietary intervention designed
to promote increased levels of plasma carotenoids, control weight, and to ensure
adequacy of micronutrient intake. Participants also undergo a physical activity
intervention comprising a moderately low aerobic regimen to raise the usual activity
level. Participants also undergo face-to-face coaching, receive educational materials
and coaching focused on how to read food labels to estimate grams of fat per serving
and serving size, and undergo telephone coaching by a lifestyle-intervention coach once
a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6
months, and then once every other month for 11 months. Participants complete a daily
Lifestyle Journal: fat gram and step diary at least three times per week.

- Group 2 (comparison lifestyle): Participants receive a blue study notebook containing
general study-related information. Participants receive telephone contact every six
months focusing on general health status.

All participants complete baseline questionnaires including demographic and lifestyle
information, medical history, and a comprehensive assessment of risk factors for ovarian
cancer. The Arizona Food Frequency Questionnaire and repeat 24-hour recalls are used to
measure dietary intake. Participants also complete physical activity assessments using the
Arizona Physical Activity Questionnaire and quality-of-life assessments using the RAND-36
and GSRS-IBS. Height, weight, body mass index, and waist circumference are measured
periodically during study. Participants undergo blood collection at baseline and at 6, 12,
and 24 months. Plasma samples are assessed for total carotenoid, alpha and beta-carotene,
lutein, lycopene, and beta-cryptoxanthin concentrations.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial cancer, fallopian tube cancer, or primary
peritoneal carcinoma, including any of the following subtypes*:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner's tumor

- Adenocarcinoma not otherwise specified

- NOTE: *However, the histologic features of the tumor must be compatible with a
primary Müllerian epithelial adenocarcinoma.

- Stage II, III, or IV disease

- No prior histological diagnosis of or treatment for clinical stage I epithelial
ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma

- Patients must have completed all primary chemotherapy and consolidation therapy (if
administered) at least 6 weeks, and no more than 4 months, prior to enrollment and
must be in complete remission

- Consolidation therapy is defined as any chemotherapy or biological therapy used
for a patient who has completed at least four courses of primary chemotherapy
and had documented complete remission prior to initiation of such chemotherapy
or biological therapy

- Patients must have achieved a documented complete response to treatment based on
normal CA-125 and CT scan (i.e., there must be no clinical evidence of persistent or
recurrent disease based on CA-125 and CT scan)

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 times upper limit normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Willing to provide names and appropriate telephone contact information and to be
contacted periodically via telephone by Arizona Diet, Behavior and Quality of Life
Shared Service staff for completion of individualized lifestyle intervention
counseling

- Life expectancy ≥ 1 year

- Body Mass Index ≥ 20 kg/m^2

- No history of other invasive malignancies within the past 5 years, except for
nonmelanoma skin cancer

- No patients enrolled in a weight-loss program or who are taking weight-loss
medications or dietary supplements and are unwilling to discontinue

- More than 24 months since prior marathon, triathlon, or other endurance-related
physical activity

- No other chronic disease that would preclude randomization into a lifestyle
intervention trial including, but not limited to, any of the following:

- Recent myocardial infarction or unstable angina (within the past 6 months)

- Chronic hepatitis

- Rheumatoid disease

- Renal or hepatic disease or dysfunction

- Diabetics receiving insulin

- Other clinical condition limiting ability to walk (e.g., recent leg fracture,
significant osteoarthritis, related orthopedic conditions, or degenerative
neurological conditions)

- No vegans

- No ongoing medically prescribed diet or physical activity regimen that has lasted for
6 months or longer

- Patients must not have a serious psychiatric illness (e.g., lifetime bipolar
disorder, schizophrenia or other psychosis, serious personality disorder, severe
major depressive disorder, recent suicide attempt, or psychiatric hospitalization
(previous 12 months)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

Unspecified

Study ID:

CDR0000594600

NCT ID:

NCT00719303

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Weight Changes
  • weight changes
  • cognitive/functional effects
  • stage IV ovarian epithelial cancer
  • stage IV primary peritoneal cavity cancer
  • ovarian serous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • ovarian mixed epithelial carcinoma
  • Brenner tumor
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • Body Weight Changes
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Batte Cancer Center at Northeast Medical CenterConcord, North Carolina  28025
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Praxair Cancer Center at Danbury HospitalDanbury, Connecticut  06810
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Billings Clinic - DowntownBillings, Montana  59107-7000
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Duke Cancer InstituteDurham, North Carolina  27710
Phelps County Regional Medical CenterRolla, Missouri  65401
Gynecologic OncologyHinsdale, Illinois  60521
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Providence Medical CenterKansas City, Kansas  66112
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Central Georgia Gynecologic OncologyMacon, Georgia  31201
CCOP - Kansas CityPrairie Village, Kansas  66208
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
St. Dominic Cancer CenterJackson, Mississippi  39216
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - OshkoshOshkosh, Wisconsin  54904
New Ulm Medical CenterNew Ulm, Minnesota  56073
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
St. Vincent Oncology CenterIndianapolis, Indiana  46260
All Saints Episcopal Hospital - Fort WorthFort Worth, Texas  76104