AzTrials
AzTrials

Ovarian CancerPhase 3WALCNCT02107066

Women's Activity and Lifestyle Study in Connecticut

A Phase 3 study testing Exercise in people with Ovarian Cancer, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
May 2009to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • exercising

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Impact of Exercise on Ovarian Cancer Prognosis

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.

Read the 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
Being tested
Exercise
Keywords
exercise, physical activity, ovarian cancer, quality of life, fatigue, weight
Medical subject headings
Ovarian Neoplasms, Motor Activity, Fatigue, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

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

Study groups in NCT02107066
Study groupRoleWhat they receive
attention controlActive comparatorWomen 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.
Receives: Behavioral: Exercise
exerciseExperimentalWomen randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107066
Sponsor's protocol ID
0904004976
Other IDs
R01CA138556
Acronym
WALC
Status last verified
Apr 2014
First submitted
17 May 2012
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37526937

  • 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.

    PubMed 37269192

  • 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.

    PubMed 35377104

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exercise in people with Ovarian Cancer, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107066, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in