Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

September 25, 2023 updated by: Mayo Clinic

Resistance Training and 1,25 (OH)2D3 Administration to 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Training and Placebo
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
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
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.
Other Names:
  • Threshold IMT Breathing Trainer
Other: 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
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.
Other Names:
  • Threshold IMT Breathing Trainer
Drug: 1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
Other Names:
  • Calcitriol
  • 1, 25-dihydroxycholecalciferol
  • Rocaltrol
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.
Other: 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
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).
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.
Other Names:
  • Threshold IMT Breathing Trainer
Drug: 1,25 (OH)2 D3
0.25 micrograms, taken daily for eight weeks, orally
Other Names:
  • Calcitriol
  • 1, 25-dihydroxycholecalciferol
  • Rocaltrol
Other: Sham Training and Placebo
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Drug: Oral Placebo
Placebo will be created to mimic the appearance of the study drug
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.
Other Names:
  • Threshold IMT Breathing Trainer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Questionnaire
Time Frame: 8 weeks
The questionnaire consists of one question with 5 choices about how often did the participant take the study agent: all the time, most of the time, half of the time only some of the time, and none of the time. Scores will be reported as categories.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Andersen Foundation

Investigators

  • Principal Investigator: Aminah Jatoi, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2018

Primary Completion (Actual)

May 21, 2020

Study Completion (Actual)

May 21, 2020

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-009440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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