Your session is about to expire
← Back to Search
Lifestyle Changes for Ovarian Cancer
Phase 3
Waitlist Available
Led By David Alberts
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have completed all primary chemotherapy and consolidation therapy at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission
Patients with specific histologic epithelial cell types including 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.) with compatible histologic features of a primary M?llerian epithelial adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
Study Summary
This trial is testing whether changes in diet and physical activity can help patients with ovarian, fallopian tube, or primary peritoneal cancer live longer without their cancer returning.
Who is the study for?
This trial is for patients with stage II-IV ovarian, fallopian tube, or primary peritoneal cancer who've finished their initial treatment within the last 6 months and are in remission. They shouldn't be on a medically prescribed diet or exercise plan, have serious chronic diseases or psychiatric illnesses, and must not have had other invasive cancers (except certain types) in the past five years.Check my eligibility
What is being tested?
The study tests if a program of diet changes, physical activity, counseling, and education can extend the time patients live without their cancer returning compared to usual care. Participants will also complete questionnaires and biomarker analyses to monitor health changes.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial involves lifestyle interventions rather than medication. However, starting a new diet or exercise routine could cause temporary discomfort like muscle soreness or digestive adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished my initial cancer treatments between 6 weeks and 6.5 months ago and am now in complete remission.
Select...
My cancer is one of the specific types listed, like serous or endometrioid adenocarcinoma.
Select...
I was diagnosed with ovarian, fallopian tube, or peritoneal cancer at an advanced stage.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer markers and scans showed no signs of cancer after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS
Change in self-reported quality of life measured using RAND-36
Other outcome measures
Change in sleep quality measured using Pittsburgh Sleep Quality Index
Change in telomere length
Changes in visceral adiposity using CT scan
+7 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (lifestyle intervention)Experimental Treatment8 Interventions
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 II: Group II (observation)Active Control3 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Dietary Intervention
2016
N/A
~70
Compliance Monitoring
2005
N/A
~840
Exercise Intervention
2016
Completed Phase 4
~1330
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
69,856 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,083 Total Patients Enrolled
David AlbertsPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone surgery to lose weight.I am currently being treated for or recently finished treatment for advanced ovarian, fallopian tube, or peritoneal cancer.I haven't had any cancer except for non-melanoma skin cancer or very early uterine cancer in the last 5 years.I finished my initial cancer treatments between 6 weeks and 6.5 months ago and am now in complete remission.My condition severely limits my daily activities.Criterion: People who only eat plant-based foods.My cancer is one of the specific types listed, like serous or endometrioid adenocarcinoma.I was diagnosed with ovarian, fallopian tube, or peritoneal cancer at an advanced stage.You have taken part in a marathon, triathlon, or similar long-distance event in the past 2 years.I can take care of myself but might not be able to do heavy physical work.My cancer markers and scans showed no signs of cancer after treatment.You are expected to live for less than one year.You have a body mass index (BMI) lower than 20 kg/m^2.I am not willing to stop my weight loss program or medications.I have been diagnosed with early-stage ovarian, fallopian tube, or peritoneal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (observation)
- Group 2: Group I (lifestyle intervention)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How risky is Quality-of-Life Assessment for patients?
"There is some efficacy data as well as multiple rounds of safety data, so our team gave Quality-of-Life Assessment a 3."
Answered by AI
In how many different medical clinics is this research study being conducted currently?
"There are 100 patients enrolling at clinical trial sites such as Sanford Broadway Medical Center in Fargo, Riverside Methodist Hospital in Columbus, and Sanford Cancer Center Oncology Clinic in Sioux Falls."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger