Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

NCT02324530 | Unknown Phase 2

• 1 other identifier: SMC-13-0637
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.

Conditions

Tumor Motion; "Continuous Positive Airway Pressure"; Lung Cancer; Breast Cancer; Abdominal Tumors

Outcome Measures

Primary Outcomes (1)

• Reduction in amplitude of tumor motion

  Measurement of the Internal Target Volume in cc

  2 months

Secondary Outcomes (1)

• Reduction of radiation dose to critical organs

  2 months

Other Outcomes (1)

• Tolerability of CPAP

  immediate

Study Arms (3)

Lung tumors

EXPERIMENTAL

Patients with \> 1 cm tumor motion simulated using 4DCT with and without CPAP

Device: Continuous positive airway pressure (CPAP)

Left sided Breast cancer

EXPERIMENTAL

Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP

Device: Continuous positive airway pressure (CPAP)

Abdominal tumors

EXPERIMENTAL

Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

CT simulation with and without CPAP

Abdominal tumors; Left sided Breast cancer; Lung tumors

Eligibility Criteria

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

You may qualify if:

• Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
• Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
• Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)

You may not qualify if:

• Under 18 years old
• Inability to sign informed consent
• Pregnancy,
• Mental Illness,
• Not legally competent

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Tel Litwinsky, 5262160, Israel

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Abdominal Neoplasms

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Zvi Symon, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffrey Goldstein, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Yaacov R Lawrence, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zvi Symon, MD

CONTACT

97235308175; symonz@sheba.health.gov.il

Hila Genesin, MsC

CONTACT

972527738123; Hila.Gnessin@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Radiation Oncology

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

IL (1)