CachexiaNCT02580422
Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia
An observational study of Cachexia and Pancreatic Cancer, run by Indiana University at 2 sites in United States.
Trial summary
Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cachexia, Pancreatic Cancer
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2015to 26 Oct 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants will be identified from the outpatient oncology clinic at the Indiana University Health Melvin and Bren Simon Cancer Center or Sidney \& Lois Eskenazi Health Hospital.
Who may be able to join
- Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC)
- Patients who are being treated and/or followed at Indiana University Simon Cancer Center or Eskenazi Hospital
- ECOG PS 0-2 at the time of study enrollment
- Life expectancy > 6 months
- Adequate organ function
- As defined by the following laboratory values at study entry:
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- Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
- ANC ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
- Total bilirubin ≤ 1.5 x ULN
- AST/ALT ≤ 3 x ULN
- Willingness to sign informed consent and to perform pulmonary function tests (PFTs) and strain echocardiogram
Who cannot join
- Known history of congestive heart failure (NYHA class III or IV)
- Reported weight loss more than 10% within 3 months prior to study entry
- Known history of pulmonary disease such as pulmonary hypertension, chronic obstructive pulmonary disease requiring medical management or previous lung resection
- Current liver cirrhosis
- Current chronic kidney disease
- Inability or refusal to receive systemic therapy
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- Inability to comply with pulmonary function tests (PFTs)
- Large volume ascites interfering with ability of respiration
- Current unstable angina (or history of within last 6 months)
- Recent myocardial infraction (within last 6 months)
- Recent pneumothorax (within last 6 months)
- Uncontrolled hypertension (per investigator's discretion)
- Lung biopsy within one week from PFT
- Recent surgery < 4 weeks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46219
About this study
Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning associated with chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains unknown. In this pilot study, the investigators propose to perform a preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop cachexia, to assess for the feasibility of performing a larger prospective study to understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent or delay its progression. Based on clinical experience and published literature, it is expected that 60-70% of patients will have >10% weight loss during the course of this disease. More commonly, this is associated with clinical or radiographic disease progression, but certainly it can happen throughout the course of the disease even without disease progression.
Read the detailed description
Primary Objective:
To assess the feasibility of performing a prospective cardiopulmonary and physical function assessment in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are expected to develop cachexia.
Secondary Objectives:
- To measure the changes in maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) in patients with progressive PDAC and/or cancer associated cachexia
- To measure changes in strain echocardiography in patients with progressive PDAC and/or cancer associated cachexia
- To assess functional changes in patients with progressive PDAC and/or cancer associated cachexia
- To assess body composition changes associated with cachexia or disease progression
- To measure the levels of cytokines from peripheral blood in patients with cachexia
Procedures:
All study procedures will be done at two time points (T1=baseline or study entry, T2=at disease progression or development of cachexia). Patients will undergo echocardiography with strain evaluation at Indiana University Health Echocardiography Laboratory and pulmonary function tests as per institutional guidelines at IUH PFT laboratory at University Hospital. Patients will also have 20mL (2 red top tubes) of blood drawn for the studies outlined in Section 7.5. Standard of care labs will be taken from the patient's medical records. Patients also will be evaluated using three standardized functional assessment tools commonly utilized in physical rehabilitation: 1) 5 Times Sit-to-Stand Test; 2) 6 Minute Walk Test; and 3) grip dynamometry. Standard of care CT scan obtained at the time of tumor assessment will enable the investigators to assess body muscle mass as described in Section 7.4. In addition, the investigators will administer three standardized survey tools to assess quality of life and prior level of function: 1) The Short Form 36 (SF-36); 2) Lower Extremity Functional Scale (LEFS); and 3) Scored Patient-Generated Subjective Global Assessment (PG-SGA).
Sample Size:
Due to the risk of clinical deterioration or drop out of the study and inability to undergo T2 evaluation, the investigators will plan on enrolling 133% of desired number of subjects, accounting for 33% missing T2 data. This is likely a high number; however, this will enable data collection from 12-15 patients at both time points and all proposed tests.
- Conditions
- Cachexia, Pancreatic Cancer
- Keywords
- Echocardiography
- Medical subject headings
- Cachexia, Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
Changes are significant if they are > 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Secondary outcomes (8)
Change in pulmonary function
Measured by comparing scores (maximal expiratory pressure [MEP] and maximal inspiratory pressure [MIP]) from forced spirometry with folow volume loop test.
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in strain echocardiogram
Measured by comparing strain echocardiograms
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported quality of life
Measured by comparing Short Form-36 questionnaire scores
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported function via LEFS questionnaire
Measured by comparing Lower Extremity Functional Scale (LEFS) questionnaire scores
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported function via PG-SGA questionnaire
Measured by comparing Patient-Generated Subjective Global Assessment (PG-SGA) questionnaire scores
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in functional evaluation test
Measured by comparing grip dynamometry, 6-minute walk test, 5-minute sit-to-stand test scores
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in body composition via CT scan
Measured by comparing CT scans that are analyzed using Sliceomatic (Tomovision) technology
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in levels of cytokines
Measured through blood samples collected at each time point which are evaluated for cytokine levels using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline to disease progression or development of cachexia (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion27 May 2017
- Study completion26 Oct 2017
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safi Shahda, Indiana University
- Investigators
- Safi Shahda, MD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580422
- Sponsor's protocol ID
- IUSCC-0547
- Status last verified
- Feb 2018
- First submitted
- 6 Oct 2015
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roberts BM, Ahn B, Smuder AJ, Al-Rajhi M, Gill LC, Beharry AW, Powers SK, Fuller DD, Ferreira LF, Judge AR. Diaphragm and ventilatory dysfunction during cancer cachexia. FASEB J. 2013 Jul;27(7):2600-10. doi: 10.1096/fj.12-222844. Epub 2013 Mar 20.
PubMed 23515443Muhlfeld C, Das SK, Heinzel FR, Schmidt A, Post H, Schauer S, Papadakis T, Kummer W, Hoefler G. Cancer induces cardiomyocyte remodeling and hypoinnervation in the left ventricle of the mouse heart. PLoS One. 2011;6(5):e20424. doi: 10.1371/journal.pone.0020424. Epub 2011 May 26.
PubMed 21637823Coats AJ. Origin of symptoms in patients with cachexia with special reference to weakness and shortness of breath. Int J Cardiol. 2002 Sep;85(1):133-9. doi: 10.1016/s0167-5273(02)00242-5.
PubMed 12163218
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia
- ClinicalTrials.gov ID
- NCT02580422
- Acronym / sponsor ID
- IUSCC-0547
- Conditions
- Cachexia, Pancreatic Cancer
- Keywords
- Echocardiography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning associated with chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains unknown. In this pilot study, the investigators propose to perform a preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop cachexia, to assess for the feasibility of performing a larger prospective study to understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent or delay its progression. Based on clinical experience and published literature, it is expected that 60-70% of patients will have >10% weight loss during the course of this disease. More commonly, this is associated with clinical or radiographic disease progression, but certainly it can happen throughout the course of the disease even without disease progression.
Detailed description
Primary Objective:
To assess the feasibility of performing a prospective cardiopulmonary and physical function assessment in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are expected to develop cachexia.
Secondary Objectives:
- To measure the changes in maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) in patients with progressive PDAC and/or cancer associated cachexia
- To measure changes in strain echocardiography in patients with progressive PDAC and/or cancer associated cachexia
- To assess functional changes in patients with progressive PDAC and/or cancer associated cachexia
- To assess body composition changes associated with cachexia or disease progression
- To measure the levels of cytokines from peripheral blood in patients with cachexia
Procedures:
All study procedures will be done at two time points (T1=baseline or study entry, T2=at disease progression or development of cachexia). Patients will undergo echocardiography with strain evaluation at Indiana University Health Echocardiography Laboratory and pulmonary function tests as per institutional guidelines at IUH PFT laboratory at University Hospital. Patients will also have 20mL (2 red top tubes) of blood drawn for the studies outlined in Section 7.5. Standard of care labs will be taken from the patient's medical records. Patients also will be evaluated using three standardized functional assessment tools commonly utilized in physical rehabilitation: 1) 5 Times Sit-to-Stand Test; 2) 6 Minute Walk Test; and 3) grip dynamometry. Standard of care CT scan obtained at the time of tumor assessment will enable the investigators to assess body muscle mass as described in Section 7.4. In addition, the investigators will administer three standardized survey tools to assess quality of life and prior level of function: 1) The Short Form 36 (SF-36); 2) Lower Extremity Functional Scale (LEFS); and 3) Scored Patient-Generated Subjective Global Assessment (PG-SGA).
Sample Size:
Due to the risk of clinical deterioration or drop out of the study and inability to undergo T2 evaluation, the investigators will plan on enrolling 133% of desired number of subjects, accounting for 33% missing T2 data. This is likely a high number; however, this will enable data collection from 12-15 patients at both time points and all proposed tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be identified from the outpatient oncology clinic at the Indiana University Health Melvin and Bren Simon Cancer Center or Sidney \& Lois Eskenazi Health Hospital.
Key inclusion criteria (13 listed)
- Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC)
- Patients who are being treated and/or followed at Indiana University Simon Cancer Center or Eskenazi Hospital
- ECOG PS 0-2 at the time of study enrollment
- Life expectancy > 6 months
- Adequate organ function
Key exclusion criteria (14 listed)
- Known history of congestive heart failure (NYHA class III or IV)
- Reported weight loss more than 10% within 3 months prior to study entry
- Known history of pulmonary disease such as pulmonary hypertension, chronic obstructive pulmonary disease requiring medical management or previous lung resection
- Current liver cirrhosis
- Current chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Changes are significant if they are > 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
8 secondary outcomes
Change in pulmonary function
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in strain echocardiogram
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported quality of life
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported function via LEFS questionnaire
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in self-reported function via PG-SGA questionnaire
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in functional evaluation test
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in body composition via CT scan
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Change in levels of cytokines
Time frame: Baseline to disease progression or development of cachexia (approximately 6 months)
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 23515443Roberts BM, Ahn B, Smuder AJ, Al-Rajhi M, Gill LC, Beharry AW, Powers SK, Fuller DD, Ferreira LF, Judge AR. Diaphragm and ventilatory dysfunction during cancer cachexia. FASEB J. 2013 Jul;27(7):2600-10. doi: 10.1096/fj.12-222844. Epub 2013 Mar 20.
- Background: PubMed 21637823Muhlfeld C, Das SK, Heinzel FR, Schmidt A, Post H, Schauer S, Papadakis T, Kummer W, Hoefler G. Cancer induces cardiomyocyte remodeling and hypoinnervation in the left ventricle of the mouse heart. PLoS One. 2011;6(5):e20424. doi: 10.1371/journal.pone.0020424. Epub 2011 May 26.
- Background: PubMed 12163218Coats AJ. Origin of symptoms in patients with cachexia with special reference to weakness and shortness of breath. Int J Cardiol. 2002 Sep;85(1):133-9. doi: 10.1016/s0167-5273(02)00242-5.
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Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
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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.
Safi Shahda, MD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia and Pancreatic Cancer, run by Indiana University at 2 sites 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 13 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
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?
The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests (time frame: Baseline to disease progression or development of cachexia (approximately 6 months)). 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 NCT02580422, 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 23 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.