Women's Activity and Lifestyle Study in Connecticut

NCT ID: NCT02107066

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-06-30

Brief Summary

Despite an increase in longevity, surviving ovarian cancer often brings an array of unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to test whether exercise compared with attention control has a beneficial impact on quality of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Detailed Description

Currently, the American Cancer Society recommends a physically active lifestyle for cancer survivors to increase disease-free survival from cancer and other chronic diseases, and to improve quality of life. Studies of a strong benefit of physical activity on improving QOL following other types of cancer treatment, e.g., breast cancer, are well documented in the literature; yet very few studies of physical activity and QOL after a diagnosis of ovarian cancer have been published. Therefore, clinical trials of exercise on common physical and psychological consequences of ovarian cancer and its treatments are warranted.

The primary aims of our study are to examine, in 230 women who have completed treatment for Stage I-IV ovarian cancer, the impact of a moderate-intensity aerobic exercise intervention vs. attention control on:

• Quality of Life
• Body Composition (weight, BMI, total and % body fat, waist and hip circumference)
• Hormones possibly associated with physical activity and ovarian cancer prognosis (insulin, IGF-I, IGF-II, IGF binding protein-3, CRP, leptin, estrone, estradiol, free estradiol, and sex-hormone binding globulin, osteopontin, MIF, prolactin, and CA-125)
• Cardiorespiratory Fitness - an objective measure of functional capacity and adherence to exercise.

Hypotheses: Women randomized to exercise will experience improvements in quality of life, body composition, hormone levels, and cardiorespiratory fitness compared to women randomized to usual care.

Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

attention control

Women randomized to attention control will receive the same attention as women randomized to exercise intervention, i.e., weekly phone calls for 6 months. Each call is about 15 min. Women in the attention control will receive information on ovarian cancer health education topics.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.

exercise

Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.

Interventions

Exercise

Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• stage I-IV ovarian cancer
• less than 76 yrs of age

Exclusion Criteria

• exercising

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melinda Irwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Cao A, Cartmel B, Li FY, Gottlieb LT, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Esserman DA, Irwin ML, Ferrucci LM. Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326463. doi: 10.1001/jamanetworkopen.2023.26463.

Reference Type: DERIVED

PMID: 37526937 (View on PubMed)

Cartmel B, Li FY, Zhou Y, Gottlieb L, Lu L, Mszar R, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Risch HA, Irwin ML. Randomized trial of exercise on cancer-related blood biomarkers and survival in women with ovarian cancer. Cancer Med. 2023 Jul;12(14):15492-15503. doi: 10.1002/cam4.6187. Epub 2023 Jun 3.

Reference Type: DERIVED

PMID: 37269192 (View on PubMed)

Cao A, Cartmel B, Li FY, Gottlieb LT, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Irwin ML, Ferrucci LM. Effect of exercise on body composition among women with ovarian cancer. J Cancer Surviv. 2023 Oct;17(5):1386-1396. doi: 10.1007/s11764-022-01207-x. Epub 2022 Apr 4.

Reference Type: DERIVED

PMID: 35377104 (View on PubMed)

Other Identifiers

R01CA138556

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0904004976

Identifier Type: -

Identifier Source: org_study_id