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Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), July 2008
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00719303
  Purpose

RATIONALE: A healthy lifestyle and counseling 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 in patients with previously treated stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Procedure: behavioral dietary intervention
Procedure: compliance monitoring
Procedure: counseling
Procedure: educational intervention
Procedure: exercise intervention
Procedure: laboratory biomarker analysis
Procedure: quality-of-life assessment
Procedure: questionnaire administration
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized
Official Title: Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?

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

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

Secondary Outcome Measures:
  • 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: 1428
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (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 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
  • Stage III or IV disease
  • No prior diagnosis of or treatment for stage I or II ovarian epithelial or primary peritoneal cancer
  • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) more than 12 weeks ago but less than 24 months ago and are 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
    • A patient may have received prior consolidation therapy for up to 12 months
  • No clinical evidence of persistent or recurrent disease based on CA 125 level and CT scan

    • All patients must have had an abnormally elevated serum CA 125 level prior to surgery or chemotherapy that has normalized to < 35 units/mL prior to study entry

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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719303

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000594600, GOG-0225
Study First Received: July 18, 2008
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00719303  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
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

Study placed in the following topic categories:
Cystadenocarcinoma, Serous
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Disease Progression
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Carcinoma, Endometrioid
Dental Caries
Carcinoma
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 13, 2009