Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Phase 4

Completed

• Conditions: Cancer
• Interventions: Other: Inspiratory isometric resistance training; Drug: 1,25 (OH)2 D3; Drug: Oral Placebo; Other: Sham Inspiratory Isometric Resistance Training; Device: Threshold Inspiratory Muscle Trainer (IMT)

• Registration Number: NCT03469271
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-19
• Study Start: 2018-05-25
• Primary Completion: 2020-05-21
• Study Completion: 2020-05-21
• Results First Submitted: 2021-05-17
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Results First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Training and Placebo	Inspiratory isometric resistance training	Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Training and Placebo	Oral Placebo	Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Training and Placebo	Threshold Inspiratory Muscle Trainer (IMT)	Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Sham Training and Vitamin D3 Metabolite	1,25 (OH)2 D3	Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
Sham Training and Vitamin D3 Metabolite	Sham Inspiratory Isometric Resistance Training	Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
Sham Training and Vitamin D3 Metabolite	Threshold Inspiratory Muscle Trainer (IMT)	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	1,25 (OH)2 D3	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	Inspiratory isometric resistance training	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	Threshold Inspiratory Muscle Trainer (IMT)	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	Oral Placebo	Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Sham Training and Placebo	Sham Inspiratory Isometric Resistance Training	Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Sham Training and Placebo	Threshold Inspiratory Muscle Trainer (IMT)	Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States