Recruiting

Chemoradiotherapy

Sponsor:

The New York Proton Center

Code:

NCT06342284

Conditions

Thoracic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proton Beam Radiation with or without concurrent chemotherapy

Study Details

Brief summary:

This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.

Conditions

Thoracic Cancer

Study ID

NCT06342284

Start date

Mar 22, 2024

Status verified date

Apr, 2026

Completion date

Mar 21, 2031

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Plan for fractionated (≥15 treatments) proton beam thoracic radiotherapy with curative intent for lung cancer
  • Non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) histology is permitted.
  • Concurrent chemotherapy is permitted but not required..
  • Previous thoracic radiotherapy is allowed.
  • Ability to complete study surveys in English or Spanish
  • Age >/= 18
  • Concurrent enrollment on other trials is permitted
  • Patients who already use wearable devices and/or smartphones that monitor physical activity are eligible for this trial, provided they agree to utilize the devices provided by the study team during the study period
  • All patients must sign study-specific informed consent prior to study entry

Exclusion Criteria:

  • Ongoing treatment for another cancer that is expected to affect the toxicity profile of thoracic radiotherapy
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Proton Beam Radiation with or without concurrent chemotherapy

Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy

Primary outcome measure

  • Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. [ Time Frame: 4-5 Weeks ]

Central Contacts and Locations

Central contacts

Nitin Ohri, MD

718-405-8550nitin.ohri@einsteinmed.edu

Ryan Holder, BS

646-968-9055rholder@nyproton.com

Locations

New York Proton Center

Recruiting

New York, New York, United States, 10035

Contacts

Ryan Holder, BS

646-968-9055rholder@nyproton.com

Thomas Mistretta, MS

646-568-5675tmistretta@nyproton.com

Principal Investigator:

Nitin Ohri, MD

More Information

Sponsor

The New York Proton Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New York Proton Center on 2026-04-13.