NCT00719303|UnknownPhase 3DMC

Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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

Gynecologic Oncology Group ClinicalTrials.gov

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6 other identifiers

GOG-0225NCI-2009-00595CDR0000594600U10CA101165U10CA180830UG1CA189867

Study Type

interventional

Target

1,070

Locations

1 country

Sites

687

Timeline

RegisteredJul 2008

StartedJun 2012

Brief Summary

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,070

participants targeted

Target at P75+ for phase_3

Geographic Reach

1 country

687 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed

3.9 years until next milestone

Study Start

First participant enrolled

June 18, 2012

Completed

8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed

Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

8.5 years

First QC Date

July 18, 2008

Last Update Submit

February 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

Progression-free survival
Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).
From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years

Secondary Outcomes (2)

Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS
Baseline to up to 24 months
Change in self-reported quality of life measured using RAND-36
Baseline to up to 24 months

Other Outcomes (10)

Change in sleep quality measured using Pittsburgh Sleep Quality Index
Baseline to 24 months
Change in telomere length
Baseline to 24 months
Changes in visceral adiposity using CT scan
Baseline to up to 14 months
+7 more other outcomes

Study Arms (2)

Group I (lifestyle intervention)

EXPERIMENTAL

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 counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week.

Behavioral: Behavioral Dietary InterventionBehavioral: Compliance MonitoringOther: CounselingOther: Educational InterventionBehavioral: Exercise InterventionOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Group II (observation)

ACTIVE COMPARATOR

Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).

Other: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Behavioral Dietary InterventionBEHAVIORAL

Receive dietary intervention

Group I (lifestyle intervention)

Compliance MonitoringBEHAVIORAL

Complete daily fat gram and step diaries

Group I (lifestyle intervention)

CounselingOTHER

Undergo face-to-face and telephone counseling

Also known as: Counseling Intervention

Group I (lifestyle intervention)

Educational InterventionOTHER

Receive educational materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (lifestyle intervention)

Exercise InterventionBEHAVIORAL

Undergo physical activity intervention

Group I (lifestyle intervention)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Group I (lifestyle intervention)Group II (observation)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (lifestyle intervention)Group II (observation)

Questionnaire AdministrationOTHER

Ancillary studies

Group I (lifestyle intervention)Group II (observation)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner?s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary M?llerian epithelial adenocarcinoma
Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, 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 (chemo) or biological therapy
Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution?s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa)
Patients must complete all pre-entry assessments
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC

You may not qualify if:

Patients with GOG performance grade of 3 or 4
Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus
Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
Patients with a life expectancy of less than one year
Patients with body mass index (BMI) \< 20 kg/m\^2
Vegan vegetarians
Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
Patients who have had surgery for weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Gynecologic Oncology Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (687)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

Tennessee Valley Gynecologic Oncology

Huntsville, Alabama, 35805, United States

SUSPENDED

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC