Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Lung Neoplasms

Esophageal Neoplasms

Respiratory Aspiration

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Esophageal Cancer

Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase)

Active Breathing Control

Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical resections, and consequently to improve the survival rates. Due to improved survival, it will become increasingly important to minimize the radiation-induced toxicity among long-term survivors.

In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the standard treatment modality. However, the dose that can be safely applied to the tumour is limited by the risk of cardiac and pulmonary complications, which even led to decreased survival in a randomised study, when a higher tumor dose was administered \[1\].

Radiation induced pulmonary and cardiac toxicity are the most important late side effects after thoracic radiotherapy \[2-4\].

The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce the toxicity risk.

In recent years, the active breathing control (ABC) technique has been introduced in the radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the heart. These patients are irradiated in the inspiration phase, in which the distance between the heart and the breast is largest, while the lungs extend.

Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For these patients the expiratory phase might theoretically be more beneficial to reduce the heart dose. However, the inspiration phase might be better for the dose to the lungs, which consequently allows cardiac dose reduction.

Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas

University Medical Center Groningen

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients will utilize biophysical feedback and coaching during the planning and treatment sessions for radiotherapy to help patients with the ABC technique.

Patients will standard of care instructions for using the ABC technique during the planning and treatment sessions for radiotherapy.

Relaxation coaching will be used in this study.

Biofeedback

Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment.

Active Breathing Control Technique

Dana B Kaplin, MPH

Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ctr

Amol Narang, MD

Amol Narang

The Investigator proposes the development of an extended reality (xR) training platform for patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to investigate the ability of this technology to provide biophysical feedback and coaching during the planning and treatment sessions to help patients with the ABC technique to improve motion management outcomes and reduce treatment related anxiety.

Pancreatic cancer (PCa) is a devastating diagnosis with one of the lowest 5-year overall survival rates of all malignancies. It is estimated that at least 45,000 Americans will die of this disease in 2019, making it the third most common cause of oncologic death. Of the patients that present without evidence of distant spread at the time of diagnosis, only a minority of patients are able to proceed directly to surgical resection which remains the mainstay treatment modality. Historical outcomes show that 30-40% of patients present with borderline resectable (BRPC) or locally advanced (LAPC) disease due to tumor involvement of local vasculature which prevents the patients from proceeding directly to surgery. In this context, neoadjuvant therapy with radiation is often administered in an attempt to downstage tumors prior to surgery, reduce the risk of a margin positive failure, and reduce the risk of local recurrence after surgery. For patients who are truly technically or medically unresectable, radiation can be offered with the intent of providing durable local control. Indeed, a recent autopsy study showed that 30 % of patients who expire from PCa do so due to the locally destructive spread from this disease, highlighting the imperative need for an optimal local control strategy.

Delivering radiation to the pancreas is technically challenging and must be carefully delivered given the risk of injury to radiosensitive organs at risk (OAR) in close proximity such as the bowel and stomach. Compounding this difficulty is the variation in positioning of the tumor and OARs due to respiratory induced motion and variation in bowel gas patterns. To achieve daily accuracy in tumor localization, the investigators employ a comprehensive strategy including strict immobilization, endoscopically placed fiducials, and daily on-board cone beam CT (CBCT). Moreover, the investigators utilize active breathing control (ABC), which requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment. Radiation to the pancreas is delivered only when the patient is holding patient's breath. During ABC, patients breathe through a snorkel-like device that records the volume of air inhaled during each breath. In this apparatus is a valve that will cut off the flow of air once the inhalation volume passes a certain threshold to ensure the same amount of volume is taken in each time a breath hold is performed. Patients are asked to press on a button to start the recording aspect of the device and then to take a deep breath hold. Once patients reach the desired threshold for the inhaled volume, the valve prevents any further air from being inhaled in, and the patient is asked to hold patient's breath for a duration of 20 - 30 seconds. The treatment team is not present in the room with the patient because of radiation exposure so it requires the patient to follow a series of with the treatment team over an intercom system. Patients are asked to do this without any visual biophysical feedback of patient's waveforms, and to do this repeatedly for multiple times per treatment session. The series of instructions can be challenging for many patients, potentially leading to prolonged treatment times and additional breath holds especially in the early fractions before patients become more familiar with the system. Furthermore, with only one planning session to become acquainted with the ABC device and treatment instructions, patients have limited practical time to gain mastery before returning for patient's actual treatment sessions. This is of concern since patients who struggle with the ABC technique may have less consistent reproducibility of daily tumor positioning which may lead to poorer radiation treatment outcomes.

The Investigator proposes the development of an extended reality (xR) training platform for patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to investigate the ability of this technology to provide biophysical feedback and coaching during the planning and treatment sessions to help patients with the ABC technique to improve motion management outcomes and reduce treatment related anxiety.

This will be a prospective, randomized, and non-blinded trial to assess the benefit of xR technology for patient education, coaching, and comfort during radiation treatment of pancreatic cancer. Prior to any use of the xR platform for patients, the investigators will perform several dry runs with the Radiation Oncology Physics department to confirm the device and platform can be used safely.

Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients

"Real-time Augmented Reality Coaching for the Breath-Hold Technique for Pancreatic SBRT Patients"

The mean range of intra-fraction variation (in millimeters) will be used in assessing the effectiveness of motion management. The result will be compared to historical controls in a "pick the winner" design.

Patient confidence will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 8 questions on a 5-point Likert scale to assess the patient's confidence in performing the ABC procedure with AR mode 1 or 2, and total score ranges from 0 to 32 with higher score signifying greater confidence.

Patient anxiety will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 20 questions on a 4-point Likert scale to assess patient anxiety with the ABC procedure and total score ranges from 20 to 80 with higher scores signifying greater anxiety with the procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas	NCT02497664	Esophageal Canc... Lung Cancer	Active Breathin...	18 Years -	University Medical Center Groningen
Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas	NCT02497664	Esophageal Canc... Lung Cancer	Active Breathin...	18 Years -	University Medical Center Groningen
Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients	NCT04843306	Pancreas Cancer	Biofeedback Active Breathin...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients	NCT04843306	Pancreas Cancer	Biofeedback Active Breathin...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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