Women's Activity and Lifestyle Study in Connecticut (WALC)

Yale University

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02107066

0904004976

R01CA138556 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• exercising

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

attention control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise

exercise

Experimental group

Description:

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

Treatment:

Behavioral: Exercise