Ovarian CancerPhase 1/2NCT06412510
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
A Phase 1/2 study testing Prehabilitation in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ovarian Cancer, Epithelial Ovarian Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- Prehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to Sep 2026
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and older
- Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or
- Patients with diagnosis of pancreatic adenocarcinoma (PDAC) (Stage I, II, or III) undergoing neoadjuvant chemotherapy.
- Patients with locally advanced esophageal cancer undergoing neoadjuvant chemotherapy.
- Patients with locally advanced muscle invasive bladder cancer undergoing neoadjuvant chemotherapy.
Who cannot join
- Life expectancy less than 3 months in the opinion of the treating physician
- Patients unable to provide informed consent.
- Wheelchair bound patients/ physical immobility.
- Severe cardiopulmonary disease defined as NYHA class III or IV
- Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded.
- Patients with any other comorbidity or condition, which, in the opinion of the enrolling investigator, would place the patient at unnecessarily higher greater risk or burden, or participating in the study would not be in the best interests of the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
Read the detailed description
Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.
- Being tested
- Prehabilitation
- Keywords
- Ovarian Cancer, Neoadjuvant chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Exercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training.
Nutrition Intervention: 30 gm protein supplement
Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and music therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Arm 1 | Experimental | Exercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training.
Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement.
Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free. Receives: Other: Prehabilitation |
| Control - Arm 2 | No intervention | Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence as calculated by the compliance percentage
Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study.
Measured: 6 weeks post intervention
Secondary outcomes (20)
Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test
Rep Max Isokinetic Strength Test measured by BiostrengthTM Maximal Strength
Measured: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test.
At baseline, and within the immediate post-exercise recovery, rating of perceived exertion (RPE; Borg scale, 6-20) will be assessed. Peak exercise exhaustion was verified if two or more of the following criteria were met: 1)96 HR within 10 bpm of age-predicted maximum HR (220-age), 2) RPE > 17, and/or 3) a plateau in HR (<3 bpm change over the last two intensity stages).
VO2 max will be calculated by ACSM's Treadmill Walking Equation:
VO2 [ml/kg/min] = (0.1 x speed) + (1.8 x Speed x Grade) 3.5 ml/kg/min
Measured: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by timed up and go test
Timed up and go test is one unit of time to measure how fast patients can move
Measured: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by grip strength test
Grip strength test measured by handheld dynamometer
Measured: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test
The number of times a patient can rise to a standing position from a seated position without the use of their upper extremities is counted in a thirty second period.
Measured: Baseline, 6 weeks post intervention
Change in measure of balance as assessed by unipedal stance test
This is a measure of balance and is assessed by asking the participant to stand on one foot (of their choice) with the lifted foot remaining close to their opposite ankle, first with eyes open and then with eyes closed.The amount of time a participant can stand on one foot is recorded.
Measured: Baseline, 6 weeks post intervention
Effectiveness of prehabilitation as assessed by measuring the change in body mass composition
Body composition measured using contrast-enhanced CT scan
Measured: Baseline, 6 weeks post-intervention
Effectiveness of prehabilitation as assessed by the change in nutritional status
Assessed for the presence of malnutrition per the Cleveland Clinic organization's standard of care based on American Society for Parenteral and Enteral Nutrition (ASPEN) and the Academy of Nutrition and Dietetics (AND) (ASPEN/AND) guidelines, and by assessing changes in the degree of malnutrition throughout the study period
Measured: Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention
Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Measured: At baseline
Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
Functional Assessment of Cancer Therapy(FACT-G7) to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Measured: Up to 6 weeks post intervention
Quality of life as assessed by FACT-O
FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Measured: At baseline
Quality of life as assessed by FACT-O
FACT-O to assess the illness is measured on a scale from 0 to 4, where 0 is 'not at all' and 4 is 'very much'
Measured: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Chemotherapy toxicity as measured by the standard CTCAE v5 grading system
Measured: At cycle 2, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Chemotherapy toxicity as measured by the standard CTCAE v5 grading system
Measured: At cycle 3, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Chemotherapy toxicity as measured by the standard CTCAE v5 grading system
Measured: At cycle 4, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Chemotherapy toxicity as measured by the standard CTCAE v5 grading system
Measured: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)
IAM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.
Measured: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)
FIM is measured on a scale of 1 to 5, where 1 is completely disagree and 5 is completely agree.
Measured: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability scale
Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal
Measured: Baseline
Effectiveness of prehabilitation as assessed by participant acceptability scale
Participant acceptability of anxiety and depression screening as measured by Hospital anxiety and depression scale(HADS) scoring from 0-21 where 0-7 is normal;8-10 is borderline abnormal; 11-21 is abnormal
Measured: Up to 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start5 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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 Case Comprehensive Cancer CenterThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanna Kelley, MD, Principal investigator, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412510
- Sponsor's protocol ID
- CASE3824
- Status last verified
- Sep 2026
- First submitted
- 8 May 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication will be shared with scientific journals during peer-review or at scientific/medical conferences/meetings. All IDP will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06412510
- Acronym / sponsor ID
- CASE3824
- Keywords
- Ovarian Cancer, Neoadjuvant chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 May 2024 (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 study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
Detailed description
Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Arm 1 | Experimental | Other: PrehabilitationExercise Intervention: Participants will be referred to Langston Hughes Community Center and work with exercise physiologists who will utilize our SmartGym ecosystem in providing exercise assessments, prescriptions, and training. Nitrition Intervention: Participants in the intervention group will be provided with 1-2 bottles of high protein oral nutritional supplements daily (ONS) to ensure that protein needs are met daily. There will be two options of ONS to choose from: one option a high calorie, high protein supplement, and the other option a low fat/low sugar, high protein supplement. Supportive care/Mind-body intervention: Participants will have access to Taussig Cancer Institute Patient Support services that are offered for free. |
| Control - Arm 2 | No intervention | –Exercise: Standard of care. Level of activity will be reported and monitored at each visit through study coordinator assessment and patient interview. Nutrition: Participants will be referred to dietitian and will be seen for a baseline evaluation, as needed throughout treatment and post treatment. A full nutrition assessment will be performed, and malnutrition diagnosis will be documented. When no malnutrition is identified participants will be provided general nutrition counseling related to their cancer type, cancer treatment, and recommendations for symptom management as needed. Those participants identified to be malnourished to any degree will receive personalized medical nutrition therapy including nutrition interventions to improve caloric intake. Supportive care/Mind-body intervention: Per standard of care, participants will be offered support services from Taussig Cancer Institute program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 and older
- Patients with diagnosis of advanced (Stage III or IV) epithelial ovarian, fallopian tube, or
- Patients with diagnosis of pancreatic adenocarcinoma (PDAC) (Stage I, II, or III) undergoing neoadjuvant chemotherapy.
- Patients with locally advanced esophageal cancer undergoing neoadjuvant chemotherapy.
- Patients with locally advanced muscle invasive bladder cancer undergoing neoadjuvant chemotherapy.
Key exclusion criteria (6 listed)
- Life expectancy less than 3 months in the opinion of the treating physician
- Patients unable to provide informed consent.
- Wheelchair bound patients/ physical immobility.
- Severe cardiopulmonary disease defined as NYHA class III or IV
- Patients with malignant bowel obstruction who will require surgical intervention or nutritional support in the form of enteral or parenteral nutrition will also be excluded.
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 |
|---|---|---|
| PrehabilitationExercise Intervention: SmartGyms, band or smartphone used to scan into the TechnoGym MyWellness kiosk, which controls the TechnoGym Excite Live and Biostrength equipment. The exercise session will consist of a program that adheres to the FITT (Frequency, Intensity, Timing, and Type) exercise prescription in accordance with ACSM 2018 ACSM Roundtable recommendations for Physical Function for combined Aerobic and Resistance training. Nutrition Intervention: 30 gm protein supplement Supportive care/Mind-body intervention: Yoga, mindfulness practices, art therapy, and music therapy | Other | Intervention - Arm 1 |
Primary outcome
Rate of adherence as calculated by the compliance percentage
Time frame: 6 weeks post intervention
Compliance will be defined as completion of at least 2 exercise sessions per week (75%) for the duration of the study.
20 secondary outcomes
Change in effectiveness of prehabilitation as assessed by 1 Rep Max Isokinetic strength test
Time frame: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by Grade Exercise Test Grade Exercise Test measured by Grade Exercise Test.
Time frame: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by timed up and go test
Time frame: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by grip strength test
Time frame: Baseline, 6 weeks post intervention
Change in effectiveness of prehabilitation as assessed by 30 second sit to stand test
Time frame: Baseline, 6 weeks post intervention
Change in measure of balance as assessed by unipedal stance test
Time frame: Baseline, 6 weeks post intervention
Effectiveness of prehabilitation as assessed by measuring the change in body mass composition
Time frame: Baseline, 6 weeks post-intervention
Effectiveness of prehabilitation as assessed by the change in nutritional status
Time frame: Baseline, Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1(each cycle is 21 days) and 6 weeks post-intervention
Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
Time frame: At baseline
Quality of life as assessed by FACT-G7 (Functional Assessment of Cancer Therapy)
Time frame: Up to 6 weeks post intervention
Quality of life as assessed by FACT-O
Time frame: At baseline
Quality of life as assessed by FACT-O
Time frame: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Time frame: At cycle 2, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Time frame: At cycle 3, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Time frame: At cycle 4, day 1(each cycle is 21 days)
Effectiveness of prehabilitation as assessed by Chemotherapy toxicity
Time frame: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using IAM(Intervention appropriateness measure)
Time frame: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability of intervention survey using FIM(Feasibility of intervention measure)
Time frame: Up to 6 weeks post intervention
Effectiveness of prehabilitation as assessed by participant acceptability scale
Time frame: Baseline
Effectiveness of prehabilitation as assessed by participant acceptability scale
Time frame: Up to 6 weeks post intervention
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication will be shared with scientific journals during peer-review or at scientific/medical conferences/meetings. All IDP will be anonymized.
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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. This study is not recruiting at the moment.
Johanna Kelley, MD principal investigator
Cleveland Clinic Foundation, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prehabilitation in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Case Comprehensive Cancer Center 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Rate of adherence as calculated by the compliance percentage (time frame: 6 weeks post intervention). 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 15 Sep 2026.