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Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Primary Purpose

Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
1,25 (OH)2 D3
Inspiratory isometric resistance training
Oral Placebo
Sham Inspiratory Isometric Resistance Training
Threshold Inspiratory Muscle Trainer (IMT)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Training and Placebo

Sham Training and Vitamin D3 Metabolite

Training and Vitamin D3 Metabolite

Sham Training and Placebo

Arm Description

Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks

Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks

Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks

Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks

Outcomes

Primary Outcome Measures

Sniff Nasal Inspiratory Pressure (SNIP)
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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2018
Last Updated
September 25, 2023
Sponsor
Mayo Clinic
Collaborators
Andersen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03469271
Brief Title
Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Official Title
Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
Andersen Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Pneumonia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training and Placebo
Arm Type
Other
Arm Description
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Arm Title
Sham Training and Vitamin D3 Metabolite
Arm Type
Other
Arm Description
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
Arm Title
Training and Vitamin D3 Metabolite
Arm Type
Other
Arm Description
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
Arm Title
Sham Training and Placebo
Arm Type
Other
Arm Description
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Intervention Type
Drug
Intervention Name(s)
1,25 (OH)2 D3
Other Intervention Name(s)
Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol
Intervention Description
0.25 micrograms, taken daily for eight weeks, orally
Intervention Type
Other
Intervention Name(s)
Inspiratory isometric resistance training
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Oral Placebo
Intervention Description
Placebo will be created to mimic the appearance of the study drug
Intervention Type
Other
Intervention Name(s)
Sham Inspiratory Isometric Resistance Training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Threshold Inspiratory Muscle Trainer (IMT)
Other Intervention Name(s)
Threshold IMT Breathing Trainer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sniff Nasal Inspiratory Pressure (SNIP)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminah Jatoi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

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