Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Study Overview
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Brief Summary
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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).

Official Title
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Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Drug: 1,25 (OH)2 D3
* Other: Inspiratory isometric resistance training
* Drug: Oral Placebo
* Other: Sham Inspiratory Isometric Resistance Training
* Device: Threshold Inspiratory Muscle Trainer (IMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer Renal and hepatic function (creatinine </= 2 x the institutional upper limit of normal; bilirubin </= 2 x the institutional upper limit of normal) No contraindication to receive either of the planned interventions of inspiratory resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider No difficulties with swallowing oral medications in the opinion of the enrolling physician Exclusion Criteria: Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8 weeks Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports unable to walk one block without difficulty) Calcium or phosphorus level above the institutional upper limit of normal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Training and Placebo<br>Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks | Other: Inspiratory isometric resistance training<br>* 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).<br>Drug: Oral Placebo<br>* Placebo will be created to mimic the appearance of the study drug<br>Device: Threshold Inspiratory Muscle Trainer (IMT)<br>* 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.<br>* Other names: Threshold IMT Breathing Trainer;|
| Other: Sham Training and Vitamin D3 Metabolite<br>Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks | Drug: 1,25 (OH)2 D3<br>* 0.25 micrograms, taken daily for eight weeks, orally<br>* Other names: Rocaltrol;Other: Sham Inspiratory Isometric Resistance Training<br>* 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.<br>Device: Threshold Inspiratory Muscle Trainer (IMT)<br>* 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.<br>* Other names: Threshold IMT Breathing Trainer;|
| Other: Training and Vitamin D3 Metabolite<br>Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks | Drug: 1,25 (OH)2 D3<br>* 0.25 micrograms, taken daily for eight weeks, orally<br>* Other names: Rocaltrol;Other: Inspiratory isometric resistance training<br>* 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).<br>Device: Threshold Inspiratory Muscle Trainer (IMT)<br>* 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.<br>* Other names: Threshold IMT Breathing Trainer;|
| Other: Sham Training and Placebo<br>Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks | Drug: Oral Placebo<br>* Placebo will be created to mimic the appearance of the study drug<br>Other: Sham Inspiratory Isometric Resistance Training<br>* 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.<br>Device: Threshold Inspiratory Muscle Trainer (IMT)<br>* 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.<br>* Other names: Threshold IMT Breathing Trainer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia