CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 63 enrolled
Drug / intervention
1,25 (OH)2 D3 +4 moredrug
Likely dose
1,25 (OH)2 D3 0.25 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03469271
NCT03469271Phase 4Completed
CompareCT.gov

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

Mayo Clinic·interventional·Posted Mar 19, 2018·Updated Sep 26, 2023

In Brief

A Phase 4 clinical trial evaluating 1,25 (OH)2 D3, Inspiratory isometric resistance training, and 3 other interventions for Cancer. Completed, enrolled 63 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States
CollaboratorsAndersen Foundation

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 19, 2018
Enrollment StartMay 25, 2018
Primary CompletionMay 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.3 years ago

Interventions

1,25 (OH)2 D3drug

0.25 micrograms, taken daily for eight weeks, orally

Inspiratory isometric resistance trainingother

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 Placebodrug

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

Sham Inspiratory Isometric Resistance Trainingother

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.