Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

NCT03469271 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 17-009440
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Keywords

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (4)

Training and Placebo

OTHER

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

Other: Inspiratory isometric resistance training; Drug: Oral Placebo; Device: Threshold Inspiratory Muscle Trainer (IMT)

Sham Training and Vitamin D3 Metabolite

OTHER

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

Drug: 1,25 (OH)2 D3; Other: Sham Inspiratory Isometric Resistance Training; Device: Threshold Inspiratory Muscle Trainer (IMT)

Training and Vitamin D3 Metabolite

OTHER

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

Drug: 1,25 (OH)2 D3; Other: Inspiratory isometric resistance training; Device: Threshold Inspiratory Muscle Trainer (IMT)

Sham Training and Placebo

OTHER

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

Drug: Oral Placebo; Other: Sham Inspiratory Isometric Resistance Training; Device: Threshold Inspiratory Muscle Trainer (IMT)

Interventions

1,25 (OH)2 D3 DRUG

0.25 micrograms, taken daily for eight weeks, orally

Also known as: Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol

Sham Training and Vitamin D3 Metabolite; Training and Vitamin D3 Metabolite

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).

Training and Placebo; Training and Vitamin D3 Metabolite

Oral Placebo DRUG

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

Sham Training and Placebo; Training and Placebo

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.

Sham Training and Placebo; Sham Training and Vitamin D3 Metabolite

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.

Also known as: Threshold IMT Breathing Trainer

Sham Training and Placebo; Sham Training and Vitamin D3 Metabolite; Training and Placebo; Training and Vitamin D3 Metabolite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Andersen Foundation: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms; Pneumonia

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Aminah Jatoi, M.D.
• Organization: Mayo Clinic

huyber.christine@mayo.edu

507-266-0984

Study Officials

• Aminah Jatoi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: May 25, 2018
• Primary Completion: May 21, 2020
• Study Completion: May 21, 2020
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)