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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
Must not have
Patients who have had surgery for weight loss
Patients with GOG performance grade of 3 or 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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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.
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My cancer markers and scans showed no signs of cancer after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have undergone surgery to lose weight.
Select...
My condition severely limits my daily activities.
Select...
I am not willing to stop my weight loss program or medications.
Select...
I have been diagnosed with early-stage ovarian, fallopian tube, or peritoneal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Secondary study objectives
Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS
Change in self-reported quality of life measured using RAND-36
Other study objectives
Changes in visceral adiposity using CT scan
Mental health measured using RAND-36 and GSRS-IBS
Pain measured using RAND-36 and GSRS-IBS
+4 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
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%
Hypothyroidism
2%
Urticaria
2%
Hemorrhoids
2%
Acute kidney injury
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

Awards & Highlights

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.

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
Completed Phase 1
~110
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
64,111 Total Patients Enrolled
12 Trials studying Fallopian Tube Carcinoma
2,655 Patients Enrolled for Fallopian Tube Carcinoma
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,019,867 Total Patients Enrolled
24 Trials studying Fallopian Tube Carcinoma
4,263 Patients Enrolled for Fallopian Tube Carcinoma
David AlbertsPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
77 Total Patients Enrolled

Media Library

Behavioral Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT00719303 — Phase 3
Fallopian Tube Carcinoma Research Study Groups: Group II (observation), Group I (lifestyle intervention)
Fallopian Tube Carcinoma Clinical Trial 2023: Behavioral Dietary Intervention Highlights & Side Effects. Trial Name: NCT00719303 — Phase 3
Behavioral Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT00719303 — Phase 3
~80 spots leftby Oct 2025
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