Ovarian CancerNCT04997096
Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
A study testing Exercise in people with Ovarian Cancer and Ovarian Carcinoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2022to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
- Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
- ≥18 years, children under the age of 18 will be excluded due to rarity of disease
- Physician's clearance to participate in moderate-vigorous intensity exercise
- Able to read, write, and understand English
- Ability to understand and the willingness to sign an informed consent document
- Willing to undergo two venous blood draws for the study
Who cannot join
- Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
- Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
- Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
- Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPH, 617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Mary Norris, MS, 857-215-0195, maryk_norris@dfci.harvard.edu
About this study
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).
Read the detailed description
This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.
The names of the study interventions involved in this study are/is:
- Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
- Attention control for 16 weeks, home-based stretching
The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.
It is expected that about 30 people will take part in this research study.
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer
- Being tested
- Exercise, Attention Control
- Keywords
- Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Aerobic Exercise, Strength Training, Cardiovascular training
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
Attention ControlOther
Home-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants randomized to one of two groups with 2:1 ratio: exercise (n=20)
- Aerobic and Resistance Exercise for 16 weeks Receives: Other: Exercise |
| Attention Control | Active comparator | Participants randomized to one of two groups with attention control (n=10).
-Attention Control for 16 weeks home-based stretching Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients completing the exercise intervention sessions.
The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher
Measured: 16 Weeks
Enrollment Rate
The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.
Measured: 16 Weeks
Secondary outcomes (4)
Short Physical Performance Battery (SPPB)-Lower Extremity Function
Short Physical Performance Battery (SPPB), an objective measure of lower-extremity function based on three timed tests of standing balance, walking speed, and chair stand tests, which in older adults is predictive of disability, nursing home admission, and all-cause mortality
Measured: 16 Weeks
Change in 6-minute walk distance
Aerobic fitness will be assessed by the 6-minute walk test (6MWT). The 6MWT has been administered in cancer survivors and has a reliability coefficient of 0.93 when tested in cancer survivors. Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes
Measured: 16 weeks
PROMIS- Physical function
Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.
Measured: 16 Weeks
Number of Participants with Treatment Related Adverse Events
NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start2 Apr 2022
- Primary completion1 Feb 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997096
- Sponsor's protocol ID
- 21-299
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04997096
- Acronym / sponsor ID
- 21-299
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer
- Keywords
- Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Aerobic Exercise, Strength Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).
Detailed description
This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.
The names of the study interventions involved in this study are/is:
- Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
- Attention control for 16 weeks, home-based stretching
The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.
It is expected that about 30 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks |
| Attention Control | Active comparator | Other: Attention ControlParticipants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
- Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
- ≥18 years, children under the age of 18 will be excluded due to rarity of disease
- Physician's clearance to participate in moderate-vigorous intensity exercise
- Able to read, write, and understand English
Key exclusion criteria (4 listed)
- Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
- Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
- Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
- Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery | Other | Exercise |
| Attention ControlHome-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer. | Other | Attention Control |
Primary outcome
Proportion of patients completing the exercise intervention sessions.
Time frame: 16 Weeks
The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher
Enrollment Rate
Time frame: 16 Weeks
The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.
4 secondary outcomes
Short Physical Performance Battery (SPPB)-Lower Extremity Function
Time frame: 16 Weeks
Change in 6-minute walk distance
Time frame: 16 weeks
PROMIS- Physical function
Time frame: 16 Weeks
Number of Participants with Treatment Related Adverse Events
Time frame: 16 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Ovarian Cancer and Ovarian Carcinoma, run by Dana-Farber Cancer Institute 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, PhD ((617) 582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients completing the exercise intervention sessions. (time frame: 16 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2026.