CancerPhase 4NCT03469271
Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
A Phase 4 study testing 1,25 (OH)2 D3, Inspiratory isometric resistance training and Threshold Inspiratory Muscle Trainer (IMT) in people with Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 1,25 (OH)2 D3, Inspiratory isometric resistance training and Threshold Inspiratory Muscle Trainer (IMT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2018to 21 May 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- 1,25 (OH)2 D3, Inspiratory isometric resistance training, Oral Placebo, Sham Inspiratory Isometric Resistance Training, Threshold Inspiratory Muscle Trainer (IMT)
- Keywords
- Pneumonia
- Medical subject headings
- Neoplasms, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,25 (OH)2 D3Drug
Also called Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol
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
Also called Threshold IMT Breathing Trainer
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.
| Study group | Role | What they receive |
|---|---|---|
| Training and Placebo | Other | Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Oral Placebo; Other: Sham Inspiratory Isometric Resistance Training; Device: Threshold Inspiratory Muscle Trainer (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start25 May 2018
- Primary completion21 May 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Andersen Foundation
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469271
- Sponsor's protocol ID
- 17-009440
- Status last verified
- Sep 2023
- First submitted
- 13 Mar 2018
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training and 1,25 (OH)2D3 Administration to Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
- ClinicalTrials.gov ID
- NCT03469271
- Acronym / sponsor ID
- 17-009440
- Conditions
- Cancer
- Keywords
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Andersen Foundation
- Study start
- 25 May 2018 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training and Placebo | Other | Other: Inspiratory isometric resistance training, Drug: Oral Placebo, Device: Threshold Inspiratory Muscle Trainer (IMT)Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks |
| Sham Training and Vitamin D3 Metabolite | Other | Drug: 1,25 (OH)2 D3, Other: Sham Inspiratory Isometric Resistance Training, Device: Threshold Inspiratory Muscle Trainer (IMT)Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks |
| Training and Vitamin D3 Metabolite | Other | Drug: 1,25 (OH)2 D3, Other: Inspiratory isometric resistance training, Device: Threshold Inspiratory Muscle Trainer (IMT)Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks |
| Sham Training and Placebo | Other | Drug: Oral Placebo, Other: Sham Inspiratory Isometric Resistance Training, Device: Threshold Inspiratory Muscle Trainer (IMT)Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1,25 (OH)2 D3Also: Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol0.25 micrograms, taken daily for eight weeks, orally | Drug | Sham Training and Vitamin D3 Metabolite, Training and Vitamin D3 Metabolite |
| Inspiratory isometric resistance trainingA 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). | Other | Training and Placebo, Training and Vitamin D3 Metabolite |
| Oral PlaceboPlacebo will be created to mimic the appearance of the study drug | Drug | Sham Training and Placebo, Training and Placebo |
| Sham Inspiratory Isometric Resistance TrainingA 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 | Sham Training and Placebo, Sham Training and Vitamin D3 Metabolite |
| Threshold Inspiratory Muscle Trainer (IMT)Also: Threshold IMT Breathing TrainerA 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. | Device | Sham Training and Placebo, Sham Training and Vitamin D3 Metabolite, Training and Placebo, Training and Vitamin D3 Metabolite |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1,25 (OH)2 D3, Inspiratory isometric resistance training and Threshold Inspiratory Muscle Trainer (IMT) in people with Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sniff Nasal Inspiratory Pressure (SNIP) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.