Women's Activity and Lifestyle Study in Connecticut

NCT02107066CompletedPHASE3INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Yale University

Enrollment

144

Start Date

2009-05-01

Completion Date

2013-06-01

Study Type

INTERVENTIONAL

Official Title

Impact of Exercise on Ovarian Cancer Prognosis

Interventions

Exercise

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

* exercising

Outcome Measures

Primary Outcomes

Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

The FACT-General (FACT-G) consists of four subscales that measure wellbeing in physical, social, emotional and functional domains. The FACT-Ovarian (FACT-O) is a disease-specific measure and is comprised of the four subscales from the FACT-G in addition to a set of items that address concerns specific to ovarian cancer

Time frame: 6 months

Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

FACT-F is a self-reporting questionnaire comprised of 13 fatigue-related items. Each item on the FACT-F is answered on a five-point scale and summed, with total scores ranging between 0 and 52. Lower scores indicate greater self-reported fatigue.

Time frame: 6 months

Change from Baseline in Short Form 36 (SF-36)

The SF-36 survey was interpreted using eight subscales (emotional, functional, pain, physical, roles-emotional, roles-physical, social, vitality) that can be combined into physical (PCS) and mental (MCS) component summary scores. The PCS score describes physical health and is composed of the general health, pain, physical functioning, and role-physical subscales. The MCS score describes mental health and is comprised of mental health, role-emotional, social functioning, and vitality subscales.

Time frame: 6 months

Locations

Yale University, New Haven, United States

Linked Papers

2023-08-01

Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer

ImportanceChemotherapy-induced peripheral neuropathy (CIPN), one of the most common and severe adverse effects of chemotherapy, is associated with worse quality of life among survivors of ovarian cancer. Currently, there is no effective treatment for CIPN.ObjectiveTo evaluate the effect of a 6-month aerobic exercise intervention vs attention-control on CIPN among women treated for ovarian cancer in the Women’s Activity and Lifestyle Study in Connecticut (WALC) to provide evidence to inform the guidelines and recommendations for prevention or treatment of CIPN.Design, Setting, and ParticipantsThis prespecified secondary analysis evaluated the Women’s Activity and Lifestyle Study in Connecticut (WALC), a multicentered, open-label, population-based, phase 3 randomized clinical trial of an aerobic exercise intervention vs attention control for CIPN in patients who were diagnosed with ovarian cancer. Only WALC participants who received chemotherapy were included in this analysis. Participants were randomized 1:1 to either a 6-month aerobic exercise intervention or to attention control. All analyses were conducted between September 2022 and January 2023.InterventionsThe exercise intervention consisted of home-based moderate-intensity aerobic exercise facilitated by weekly telephone counseling from an American College of Sports Medicine/American Cancer Society–certified cancer exercise trainer. Attention control involved weekly health education telephone calls from a WALC staff member.Main Outcomes and MeasureChange in CIPN was the primary outcome in this secondary analysis. This outcome was represented by CIPN severity, which was self-measured by participants at baseline and 6 months using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity scale, with a score range of 0 to 44. A mixed-effects model was used to assess the 6-month change in CIPN between the exercise intervention and attention control arms.ResultsOf the 134 participants (all females; mean [SD] age, 57.5 [8.3] years) included in the analysis, 69 were in the exercise intervention arm and 65 were in the attention control arm. The mean (SD) time since diagnosis was 1.7 (1.0) years. The mean (SD) baseline CIPN scores were 8.1 (5.6) in the exercise intervention arm and 8.8 (7.9) in the attention control arm (P = .56). At 6 months, the self-reported CIPN score was reduced by 1.3 (95% CI, −2.3 to −0.2) points in the exercise intervention arm compared with an increase of 0.4 (95% CI, −0.8 to 1.5) points in the attention control arm. The between-group difference was −1.6 (95% CI, −3.1 to −0.2) points. The point estimate was larger among the 127 patients with CIPN symptoms at enrollment (−2.0; 95% CI, −3.6 to −0.5 points).Conclusions and RelevanceFindings of this secondary analysis of the WALC trial indicate that a 6-month aerobic exercise intervention vs attention control significantly improved self-reported CIPN among patients who were treated for ovarian cancer. While replication of the findings in other studies is warranted, incorporating referrals to exercise programs into standard oncology care could reduce CIPN symptoms and increase quality of life in patients with ovarian cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT02107066

2023-06-03

Randomized trial of exercise on cancer‐related blood biomarkers and survival in women with ovarian cancer

AbstractBackgroundIn randomized trials in women with breast cancer, exercise has been shown to have beneficial effects on cancer‐related circulating biomarkers that may impact survival. Such studies are lacking for ovarian cancer.MethodsThis secondary analysis of a published randomized controlled trial examined the impact of a 6‐month exercise intervention versus attention‐control on change in prespecified circulating biomarkers (cancer antigen 125 (CA‐125), C‐reactive protein (CRP), insulin‐like growth factor‐1(IGF‐1), insulin and leptin) in a subset of participants who provided a fasting blood draw (N = 104/144) at enrollment and at 6 months. Change in biomarkers between study arms was compared using a linear mixed effects model analysis. An exploratory analysis of the exercise intervention versus attention‐control on all‐cause mortality included all (N = 144) participants. All statistical tests were two‐sided.ResultsParticipants included in the biomarker analysis were 57.0 ± 8.8 (mean ± SD) years old and 1.6 ± 0.9 years post‐diagnosis. Adherence to the exercise intervention was 176.4 ± 63.5 min/week. Post intervention IGF‐1 (group difference in change: −14.2 (−26.1 to −2.3) ng/mL (least squared means (95% CI))) and leptin (−8.9 (−16.5 to −1.4) ng/mL) were significantly reduced in the exercise group (N = 53) compared to those in attention‐control (N = 51). No group difference in change was seen for CA‐125 (p = 0.54), CRP (p = 0.95), or insulin (p = 0.37). With median follow‐up of 70 months [range 6.6–105.4 months], 50/144 (34.7%) (exercise group; 24/74 (32.4%) versus attention‐control group; 26/70 (37.1%)) participants died with no between group difference in overall survival (p = 0.99).ConclusionsFurther studies are needed to determine the clinical significance of exercise‐induced changes in cancer‐related circulating biomarkers in women with ovarian cancer.

2022-04-04

Effect of exercise on body composition among women with ovarian cancer

Obesity is associated with a higher risk of mortality in women with ovarian cancer. Exercise has improved body composition among cancer survivors, yet no randomized controlled trial has explored the effect of exercise on body composition in women with ovarian cancer. In this analysis, we examined the effect of a six-month aerobic exercise intervention on body composition among ovarian cancer survivors in the Women's Activity and Lifestyle Study in Connecticut (WALC). Women with ovarian cancer (N = 144) were randomized in a 1:1 ratio to 6 months of an aerobic exercise intervention or attention-control, and body composition was measured as a secondary outcome at baseline and 6 months via dual-energy X-ray absorptiometry (DEXA). Women with at least one DEXA scan were included in the analysis (N = 103). On average, participants were 57.1 (± 8.7) years old and 1.6 (± 0.9) years since diagnosis. Women randomized to exercise maintained weight during the trial (- 0.11 kg, P = 0.82), while women in attention-control gained weight (+ 1.40 kg, P = 0.03); however, the between-group difference did not reach statistical significance (P = 0.09). We found no statistically significant differences by study arm for changes in body fat percentage, bone mineral density, or lean body mass. Weight was maintained as a result of a 6-month aerobic exercise intervention among post-treatment ovarian cancer survivors. Future exercise and healthy eating interventions should consider additional measures (e.g., computer tomography scans, D Moderate-intensity aerobic exercise may help ovarian cancer survivors maintain weight.

Linked Investigators

Anlan Cao

Brenda Cartmel