Trial record 1 of 1 for:    NCT00719303
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Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00719303
First received: July 18, 2008
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

RATIONALE: A healthy lifestyle and counseling (coaching) after treatment may improve progression-free survival in patients with previously treated cancer.

PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival of patients with previously treated stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention Phase
Cognitive/Functional Effects
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Weight Changes
Behavioral: behavioral dietary intervention
Behavioral: compliance monitoring
Behavioral: exercise intervention
Behavioral: telephone-based intervention
Other: counseling intervention
Other: educational intervention
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Official Title: Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved quality of life and physical function [ Designated as safety issue: No ]
  • Blood markers in predicting progression or death [ Designated as safety issue: No ]
  • Blood markers in predicting recurrence or survival [ Designated as safety issue: No ]
  • Plasma carotenoid levels [ Designated as safety issue: No ]
  • Patient compliance [ Designated as safety issue: No ]
  • Impact on other aspects of quality of life [ Designated as safety issue: No ]
  • Impact on bowel function [ Designated as safety issue: No ]

Estimated Enrollment: 1070
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719303

  Show 132 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David S. Alberts, MD University of Arizona
Principal Investigator: Philip J. DiSaia, MD Gynecologic Oncology Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00719303     History of Changes
Other Study ID Numbers: CDR0000594600, GOG-0225
Study First Received: July 18, 2008
Last Updated: October 25, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Body Weight Changes
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Body Weight
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013