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| Name | Class |
|---|---|
| Andersen Foundation | OTHER |
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This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training and Placebo | Other | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks |
|
| Sham Training and Vitamin D3 Metabolite | Other | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks |
|
| Training and Vitamin D3 Metabolite | Other | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks |
|
| Sham Training and Placebo | Other | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1,25 (OH)2 D3 | Drug | 0.25 micrograms, taken daily for eight weeks, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sniff Nasal Inspiratory Pressure (SNIP) | SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded. | 8 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Nothing to report
A study coordinator worked closely with Dr. Jatoi in numerous clinics in the Division of Medical Oncology to identify potential candidates for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Training and Placebo | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Oral Placebo: Placebo will be created to mimic the appearance of the study drug Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| FG001 | Sham Training and Vitamin D3 Metabolite | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| FG002 | Training and Vitamin D3 Metabolite | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| FG003 | Sham Training and Placebo | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Training and Placebo | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Oral Placebo: Placebo will be created to mimic the appearance of the study drug Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sniff Nasal Inspiratory Pressure (SNIP) | SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded. | Patients completing all 8 weeks of treatment. | Posted | Mean | Full Range | cmH20 | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training and Placebo | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Oral Placebo: Placebo will be created to mimic the appearance of the study drug Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | 507-266-0984 | huyber.christine@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2018 | May 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Inspiratory isometric resistance training | Other | A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). |
|
| Oral Placebo | Drug | Placebo will be created to mimic the appearance of the study drug |
|
| Sham Inspiratory Isometric Resistance Training | Other | A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. |
|
| Threshold Inspiratory Muscle Trainer (IMT) | Device | A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
|
|
| BG001 | Sham Training and Vitamin D3 Metabolite | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| BG002 | Training and Vitamin D3 Metabolite | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| BG003 | Sham Training and Placebo | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham Training and Vitamin D3 Metabolite | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| OG002 | Training and Vitamin D3 Metabolite | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
| OG003 | Sham Training and Placebo | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham Training and Vitamin D3 Metabolite | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Training and Vitamin D3 Metabolite | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks 1,25 (OH)2 D3: 0.25 micrograms, taken daily for eight weeks, orally Inspiratory isometric resistance training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax). Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Sham Training and Placebo | Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug Sham Inspiratory Isometric Resistance Training: A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax. Threshold Inspiratory Muscle Trainer (IMT): A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |