← 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

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

Select...

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.

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 weeks3 visits

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

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

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

~130

Compliance Monitoring

2005

N/A

~840