Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
试验速览
- 阶段
- 3 期
- 入组人数
- 1,070
- 试验地点
- 1,372
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group I (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.
干预措施: Behavioral Dietary Intervention (Behavioral)
Group I (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.
干预措施: Compliance Monitoring (Behavioral)
Group I (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.
干预措施: Counseling (Other)
Group I (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.
干预措施: Educational Intervention (Other)
Group I (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.
干预措施: Exercise Intervention (Behavioral)
Group I (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.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (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.
干预措施: Quality-of-Life Assessment (Other)
Group I (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.
干预措施: Questionnaire Administration (Other)
Group II (observation)
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).
干预措施: Laboratory Biomarker Analysis (Other)
Group II (observation)
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).
干预措施: Quality-of-Life Assessment (Other)
Group II (observation)
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).
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Progression-free survival
时间窗: 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
Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).
次要结局
- 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)