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Phase 4 N=63 Randomized Triple-blind Supportive Care

Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03469271 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Sniff Nasal Inspiratory Pressure (SNIP) — 90; 87; 89; 109 cmH20

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
1,25 (OH)2 D3 (Drug); Inspiratory isometric resistance training (Other); Oral Placebo (Drug); Sham Inspiratory Isometric Resistance Training (Other); Threshold Inspiratory Muscle Trainer (IMT) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Sniff Nasal Inspiratory Pressure (SNIP)		 90; 87; 89; 109 —

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).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03469271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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