Cancer
Conditions
Keywords
Pneumonia
Brief summary
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).
Interventions
DRUG1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
OTHERInspiratory 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).
DRUGOral Placebo
Placebo will be created to mimic the appearance of the study drug
OTHERSham 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.
DEVICEThreshold 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.
Sponsors
Andersen Foundation
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sniff Nasal Inspiratory Pressure (SNIP) | 8 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
A study coordinator worked closely with Dr. Jatoi in numerous clinics in the Division of Medical Oncology to identify potential candidates for this study.
Pre-assignment details
Nothing to report
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 15 |
| 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. | 15 |
| 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. | 17 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 11 Participants | 15 Participants | 51 Participants |
| Age, Continuous | 52.5 years | 58 years | 55 years | 51 years | 54 years |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 15 participants | 15 participants | 16 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 13 Participants | 12 Participants | 50 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 17 |
Outcome results
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.
Time frame: 8 weeks
Population: Patients completing all 8 weeks of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Training and Placebo | Sniff Nasal Inspiratory Pressure (SNIP) | 90 cmH20 |
| Sham Training and Vitamin D3 Metabolite | Sniff Nasal Inspiratory Pressure (SNIP) | 87 cmH20 |
| Training and Vitamin D3 Metabolite | Sniff Nasal Inspiratory Pressure (SNIP) | 89 cmH20 |
| Sham Training and Placebo | Sniff Nasal Inspiratory Pressure (SNIP) | 109 cmH20 |