Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Cancer

Treatments: Drug: 1,25 (OH)2 D3; Drug: Oral Placebo; Other: Sham Inspiratory Isometric Resistance Training; Device: Threshold Inspiratory Muscle Trainer (IMT); Other: Inspiratory isometric resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT03469271

17-009440

Details and patient eligibility

About

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).

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

63 participants in 4 patient groups

Training and Placebo

Other group

Description:

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

Treatment:

Other: Inspiratory isometric resistance training

Drug: Oral Placebo

Device: Threshold Inspiratory Muscle Trainer (IMT)

Sham Training and Vitamin D3 Metabolite

Other group

Description:

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

Treatment:

Other: Sham Inspiratory Isometric Resistance Training

Device: Threshold Inspiratory Muscle Trainer (IMT)

Drug: 1,25 (OH)2 D3

Training and Vitamin D3 Metabolite

Other group

Description:

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

Treatment:

Other: Inspiratory isometric resistance training

Device: Threshold Inspiratory Muscle Trainer (IMT)

Drug: 1,25 (OH)2 D3

Sham Training and Placebo

Other group

Description:

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

Treatment:

Other: Sham Inspiratory Isometric Resistance Training

Drug: Oral Placebo

Device: Threshold Inspiratory Muscle Trainer (IMT)