Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

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).

Conditions

• Cancer

Interventions

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.

Sponsors & Collaborators

• Andersen Foundation

  collaborator OTHER

• Mayo Clinic

  lead OTHER

Principal Investigators

• Aminah Jatoi · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-25

Primary Completion

2020-05-21

Completion

2020-05-21

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations