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Completed

NCT Number: NCT03469271

Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

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).

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Key information

Conditions

Cancer Infections Lung Diseases Neoplasms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1,25 (OH)2 D3

Drug

0.25 micrograms, taken daily for eight weeks, orally

Other names: Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol

Inspiratory isometric resistance training

Other

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

Drug

Placebo will be created to mimic the appearance of the study drug

Sham Inspiratory Isometric Resistance Training

Other

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)

Device

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.

Other names: Threshold IMT Breathing Trainer

Primary outcomes

  1. Sniff Nasal Inspiratory Pressure (SNIP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Andersen Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2018
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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