Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469271
• Other study ID #: 17-009440
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2018
• Est. completion date: May 21, 2020

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 21, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pneumonia

Intervention

Drug:
• 1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally

Other:
• 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).

Drug:
• Oral Placebo
Placebo will be created to mimic the appearance of the study drug

Other:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Andersen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks

External Links

•   Mayo Clinic Clinical Trials