CLINICAL TRIAL / NCT00719303
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
- Interventional
- Active
- NCT00719303
Contact Information
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
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.
PRIMARY OBJECTIVES:
I. To determine if women who are disease-free after successfully completing primary and
potential consolidation/maintenance, therapy for stage II-IV ovarian, fallopian tube or
primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will
have significantly increased progression-free survival compared to similar women who are
randomized to a usual care comparison group.
SECONDARY OBJECTIVES:
I. To determine if women who are randomized to the study intervention will have improved
general quality of life as measured by the General Health subscale of Research and
Development (RAND) 36-Item Health Survey (RAND-36).
II. To determine if women who are randomized to the study intervention will have improved
physical and bowel functioning as measured by the Physical Functioning subscale of RAND-36
and the Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS), compared
to women who are randomized to usual care.
TERTIARY OBJECTIVES:
I. To assess patient compliance with the healthy lifestyle intervention by analyzing
biomarkers (e.g., total carotenoid) at baseline, 6, 12, and 24 months.
II. To explore the relationship between carotenoid exposure and progression free survival
from ovarian cancer.
III. 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.
IV. 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.
V. To explore the impact of the intervention on bowel functioning as measured with the
GSRS-IBS subscales.
VI. To assess the association between subjectively measured sleep duration/quality (using the
Pittsburgh Sleep Quality Scale), anthropometric measurements, and self-reported dietary
energy intake among women previously treated for stage II-IV ovarian or primary peritoneal
cancer.
VII. To assess and compare telomere length and rate of telomere shortening between ovarian
cancer survivors randomized to lifestyle intervention versus standard of care.
VIII. To assess effects of the intervention on biomarkers of metabolic health as measured by
changes in circulating insulin and related insulin resistance, lipids and inflammation.
IX. To determine if the intervention effect on the biomarkers listed above is modified by
baseline central adiposity.
X. To determine if the intervention effect on biomarkers listed above is mediated by change
in central adiposity.
XI. To evaluate changes in central adiposity using computerized tomography (CT) scan data
from regularly scheduled, routine surveillance CT scans to determine if change in CT-specific
visceral adiposity is associated with changes in biomarkers of metabolic deregulation and
inflammation in a random subsample.
OUTLINE: 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 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.
GROUP 2 (COMPARISON LIFESTYLE): 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).
After completion of study, participants are followed up every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Note: women will not be excluded if their baseline lifestyle assessment indicates
a healthy eating and moderate physical activity with the exception of the
exclusion criteria above