Trial Outcomes & Findings for Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients (NCT NCT03469271)

NCT ID: NCT03469271

Last Updated: 2023-09-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 63 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2023-09-26

Participant Flow

A study coordinator worked closely with Dr. Jatoi in numerous clinics in the Division of Medical Oncology to identify potential candidates for this study.

Nothing to report

Participant milestones

Measure	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.	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.	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.	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.
Overall Study STARTED	16	15	15	17
Overall Study COMPLETED	14	15	15	16
Overall Study NOT COMPLETED	2	0	0	1

Reasons for withdrawal

Measure	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.	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.	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.	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.
Overall Study Withdrawal by Subject	2	0	0	1

Baseline Characteristics

Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Baseline characteristics by cohort

Measure	Training and Placebo n=16 Participants 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.	Sham Training and Vitamin D3 Metabolite n=15 Participants 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.	Training and Vitamin D3 Metabolite n=15 Participants 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.	Sham Training and Placebo n=17 Participants 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.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	51 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Age, Continuous	52.5 years n=5 Participants	58 years n=7 Participants	55 years n=5 Participants	51 years n=4 Participants	54 years n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	50 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	14 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	16 participants n=4 Participants	60 participants n=21 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Patients completing all 8 weeks of treatment.

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.

Outcome measures

Measure	Training and Placebo n=14 Participants 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.	Sham Training and Vitamin D3 Metabolite n=15 Participants 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.	Training and Vitamin D3 Metabolite n=15 Participants 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.	Sham Training and Placebo n=16 Participants 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.
Sniff Nasal Inspiratory Pressure (SNIP)	90 cmH20 Interval 51.0 to 190.0	87 cmH20 Interval 51.0 to 159.0	89 cmH20 Interval 43.0 to 150.0	109 cmH20 Interval 74.0 to 153.0

Adverse Events

Training and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Training and Vitamin D3 Metabolite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Training and Vitamin D3 Metabolite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Training and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aminah Jatoi, M.D.

Mayo Clinic

Phone: 507-266-0984

Email: huyber.christine@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place