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
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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? |
- Progression-free survival [ Designated as safety issue: No ]
- 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 |
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
Show 132 Study Locations| 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 June 17, 2013