ClinicalTrials.gg
Not yet recruitingNCT07932106Updated Nov 12, 2026

Identifying Mediators of Exercise-induced Tumor Microenvironment Remodeling to Enhance Primary Chemotherapy Response (IMPROVE-Ovarian)

An interventional study of Exercise and Usual Care in High Grade Serous Ovarian, Ovarian Adenocarcinoma and Ovarian Cancer, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.

Planned enrollment
1,128th of 1,497
20 · median 47
Started
2026
with 63 others
No phase
202 of 1,778
46 open now
Primary completion
2027-08
later than 237 of 453 live
Registered
1,776th of 1,778
by date

Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 1,128th largest by planned enrollment of the 1,497 interventional ones that give a count, is one of 64 that started in 2026, is one of 202 with no phase, reaches primary completion later than 237 of the 453 other live ones, and was the 1,776th registered.

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:

275 more — sign in →

All 280 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 606 Ovarian Neoplasms studies recruiting now, 443 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,778 studies in Ovarian Neoplasms with a site in United States, or all of them as a file.
02

Study summary

The goal of this study is to (1) determine the feasibility and acceptability of a telehealth-delivered exercise intervention (including resistance and aerobic training) during neoadjuvant chemotherapy (NACT) for women with high-grade serous ovarian cancer (HGSOC) and to (2) determine the effect of exercise on changes in immune function, inflammation, and treatment response.

03

Conditions studied

  • High Grade Serous Ovarian
  • Ovarian Adenocarcinoma
  • Ovarian Cancer
  • Serous Adenocarcinoma of Ovary
  • Ovarian Cancer (OvCa)

Keywords

  • Prehabilitation
  • Exercise
  • High grade serous ovarian cancer
  • Ovarian cancer
  • Neoadjuvant chemotherapy
  • Pre-surgical exercise
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women, age ≥ 18 years old
  • Diagnosed with high-grade serous ovarian cancer
  • Treatment plan includes chemotherapy followed by potential interval debulking surgery at UPMC Magee Womens Hospital, UPMC Hillman Cancer Center, UPMC Shadyside Hospital, or UPMC Passavant Hospital
  • Consented to participate in STUDY19060197: HCC 07-058
  • Neoadjuvant chemotherapy has not yet been initiated
  • Performance Status Scale score of ≤ 2
  • Ability to provide written
  • Ability to understand, speak, and read English. (Many of the study instruments utilized are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists and clinical research coordinators, are not bilingual.)

Exclusion criteria

Exclusion Criteria:

  • Evidence in the EHR of an absolute for exercise (e.g., Heart insufficiency > III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
  • Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
  • Receiving non-HGSOC related chemotherapy and/or radiotherapy
  • Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Telehealth-delivered exercise (EX)

    Participants who opt-in to the exercise intervention will be in this arm. The intervention will include a tele-health delivered exercise program (resistance and aerobic exercise) lasting 9-12 weeks concurrent with their neoadjuvant chemotherapy.

    Behavioral: Exercise

  • Active comparator
    Usual care (UC)

    The UC group will not receive any intervention during study participation and will undergo usual medical treatment. There is no intervention for this arm. They will be provided with a welcome packet with basic study information and educational materials on exercise during cancer treatment and their research participation will be surveillance-based assessments only during the duration of the study.

    Behavioral: Usual Care

Interventions

  • BehavioralExercise

    The exercise intervention will last approximately 9-12 weeks, running concurrently with their neoadjuvant chemotherapy, and will include resistance training two times per week and aerobic exercise 3-5 times per week. The prescribed exercise will be personalized based on the participant's baseline functionality and will be adjusted as needed throughout their participation based on any disease or chemotherapy-related side effect.

  • BehavioralUsual Care

    The UC group will not receive any intervention during study participation and undergo usual medical treatment and surveillance during the duration of the study.

06

What researchers measure

Primary outcomes

  1. Acceptability of Intervention

    Acceptability will be defined as ≥60% of women approached for study participation will agree to participate and opt in to the exercise intervention.

    Time frame: From enrollment until study completion, approximately 3-4 months

  2. Adherence to intervention

    Exercise adherence will be calculated as the proportion of completed exercise sessions over the number of prescribed sessions.

    Time frame: From enrollment until study completion, approximately 3-4 months

  3. Feasibility of Intervention

    Feasibility will be defined as ≥60% adherence to the prescribed exercise intervention.

    Time frame: From enrollment until study completion, approximately 3-4 months

Secondary outcomes

  1. Six-minute walk test (6MWT)

    Cardiorespiratory fitness will be measured using the six minute walk test. The 6MWT is an objective evaluation of functional exercise capacity. Its results are highly correlated with those of the 12-minute walk test from which it was derived and with those of cycle ergometer or treadmill-based exercise tests.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  2. 30-second chair stand test (30CST)

    Lower body strength will be evaluated using the 30 second chair stand test. The participant is seated in the middle of the chair, back straight, feet approximately shoulder width apart and placed on the floor. Arms are crossed at the wrists and held against the chest. At the signal "go," the participant rises to a full body stand and then returns to the initial seated position. The participant is encouraged to complete as many full stands as possible within 30 seconds.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  3. 2-Minute Step Test

    Cardiorespiratory fitness will be measured with the 2-minute step test. Participants will be marching in place for 2 minutes and are encouraged to use a chair for balance or do the assessment seated if standing is too difficult. They should be lifting their legs about 6 inches off the ground, as if they were stepping onto a curb from the road. The tester will count the number of times the participant raises their right leg off the ground.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  4. Timed-Up-and-Go (TUG) test

    The TUG evaluates lower body strength, balance, and agility. The patient sits in a chair and on the command "go", the patient rises from the chair, walks 3 meters at a self-selected pace, turns around an obstacle, walks back to the chair and sits down. Test results may also be quantified assessing the time (seconds) needed to complete the assessment.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  5. Handgrip assessment

    Maximum capacity to squeeze with each hand may be assessed using a hand grip dynamometer. Each hand may be assessed three times.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  6. Short Physical Performance Battery (SPPB)

    The SPPB is a short battery of performance tests of lower extremity functioning. The tests measure gait speed, standing balance, and lower extremity strength and power. To test gait speed, patients are instructed to walk an 4-meter walking course at their usual pace with assistive devices if needed. Three progressively more challenging positions are used to test balance (bipedal \[feet next to each other\], semi-tandem \[one foot slightly in front of the other\], and full tandem \[one foot in front of the other\]). To test lower extremity strength, patients are asked to stand up and sit down five times as quickly as possible and are timed from the initial sitting position to the final standing position at the end of the fifth stand. The scores for the overall assessment is the sum of the scores of each of the subtests. The scores for the individual subtests on their own are not research validated data points. Min = 0; Max = 12; higher score = better performance

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  7. SARC-F Sarcopenia scale

    The SARC-F questionnaire is a short 5-item battery containing observational assessments that is a rapid diagnostic test for sarcopenia. There are 5 SARC-F components: Strength, Assistance with walking, Rise from a chair, Climb Stairs, and Falls. Min = 0; Max = 10; higher score = higher risk for sarcopenia

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  8. Edmonton Frail Scale (EDS)

    The Edmonton Frail Scale is a reliable measure for frailty that is easy to use, captures the multidimensional aspects of fatigue, and presents the level of frailty along a continuum so that change over time can be captured. The semi-structured interview collects data across 9 frailty domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. Scores fall within one of 5 categories (not frail, vulnerable, mild frailty, moderate frailty, severe frailty) and range from 0 (not frail) to 17 (severe frailty). Min = 0; Max = 17; higher score = higher frailty risk

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  9. Fried Frailty Index for physical frailty (FFI)

    The Fried Frailty Index is a short battery of physical performance tests and observational assessments that evaluate phenotypic frailty. The index evaluates weight loss in the past year, weakness via grip strength, self-reported fatigue, gait speed, and self-reported physical activity levels. The score for the index is the sum of the scores of each of the measured items listed above. The scores for the individual items on their own are not research validated data points. Min = 0; Max = 5; higher score = higher frailty risk

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  10. EORTC QLQ-C30 Quality of Life (QoL)

    QoL may be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi- item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores are derived according to the EORTC scoring manual. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  11. EORTC QLQ-OV28 Ovarian Cancer-related QOL

    Ovarian cancer specific QoL may be further assessed with the validated 28-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-OV28). It includes seven multi-item symptom and functional scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side effects, hormonal/menopausal symptoms, body image, attitude to disease treatment, and sexual functioning). Scores are derived according to the EORTC scoring manual. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  12. Multidimensional Fatigue Inventory

    Fatigue may be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire. It covers five different dimensions of fatigue (general, physical, reduced activity, reduced motivation, and mental). Scores are derived by summing the answers (five-stage scale) of the appropriate items. Min = 20; Max = 100; higher score = less fatigue

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  13. Godin Leisure Time Exercise

    Physical activity patterns during a patient's leisure time may be assessed using the Godin Leisure Time Exercise questionnaire. The questionnaire asks patients to recall, during a seven-day period, the frequency to which they participated in strenuous, moderate, and mild exercise. The Godin questionnaire is short and easy to complete. Min = 0; Max = none; higher score = more activity

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  14. PROMIS Cognitive Function- Short Form

    Cognitive function may be measured by the 8-item PROMIS questionnaire. The questionnaire assesses patient-perceived cognitive deficits including mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Min = 8; Max = 40; higher score = better cognitive function

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  15. PG-SGA Nutrition Assessment- Short Form

    The Patient-Generated Subjective Global Assessment (PG-SGA) is a patient-reported instrument for assessment of nutrition status in patients with cancer. The PG-SGA short form is completed by patients and screens for nutritional risk and deficit. Min = 0, Max = 36; higher score = worse nutrition status

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  16. Brief Pain Inventory (BPI)

    The BPI is a 9-item, self-assessment questionnaire that has been largely validated. The BPI measures both the intensity of pain (sensory dimension) and interference of pain in the participant's life (reactive dimension). It also asks the participant about pain relief, pain quality, and participant perception of the cause of pain. Pain Severity: Min = 0; Max = 40; higher score = higher pain severity Pain Interference: Min = 0; Max = 7; higher score = higher pain interference

    Time frame: Baseline, midway through NACT (approximately 6 weeks after baseline), and after completion of NACT (approximately 3-4 months after baseline).

  17. Feasibility of Intervention Measure (FIM)

    The FIM is a 4-item measure used to measure and compare participant feasibility of an intervention. This will only be completed by those in the EX group. Min = 4; Max = 20; higher score = higher intervention feasibility

    Time frame: After completion of NACT (at approximately 3-4 months)

  18. Acceptability of Intervention Measure (AIM)

    The AIM is a 4-item measure used to measure and compare participant acceptability of an intervention. This will only be completed by those in the EX group. Min = 4; Max = 20; higher score = higher intervention acceptability

    Time frame: After completion of NACT (at approximately 3-4 months)

  19. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. The PRO-CTCAE item library contains 124 items representing 78 symptomatic toxicities. Specific items will be selected to create an individualized form specific to this study population. The questions ask first about the presence of different symptoms, then, if the symptom is present, follow up questions will automatically populate asking about the severity and/or interference for that particular symptom. The PRO-CTCAE will be used to design the weekly Ecological Momentary Assessments. Symptom Frequency: Min = 0; Max = 44; higher score = higher symptom frequency Symptom Severity: Min = 0; Max = 60; higher score = higher symptom severity Symptom Interference: Min = 0; Max = 56; higher score = higher symptom interference

    Time frame: Weekly from baseline through completion of the study (for approximately 3-4 months)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.

Of 282 non-industry interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 76. This study's planned 8 months is below that.

Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 23 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Nov 12, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Sep 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932106
Responsible party
Melanie Potiaumpai (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Nov 12, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Cara Battistella
Contact
battistellac@upmc.edu
878-261-6693
Melanie Potiaumpai
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion