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Radiation

Intensity-modulated radiation therapy (IMRT) for Lymphedema

N/A

Waitlist Available

Led By Carmen Perez, M.D.

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto 10 year follow up

Awards & highlights

Study Summary

This trial is investigating a new treatment for breast cancer that involves radiotherapy. 15 fractions of radiotherapy will be given to the affected breast and to the Axillary level III and SCV lymph nodes. This will be done using the IMRT technique, which is a new way of doing radiation therapy that is more precise. Patients will be seen for follow-up at 45-60 days from the start of treatment, and then yearly. The trial will assess the side effects of the treatment and how well it works. Patients will also complete a self-assessment of their quality of life at different times during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 10 year follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto 10 year follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 10 year follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Met Constraints

Number of Participants With Acute Toxicity > Grade 2 (Skin Toxicity Grade 3 or Above) Occurring Within 60 Days After First Day of Treatment

Secondary outcome measures

Evaluate changes in QOL of patients

Radiation Sickness

Incidence of re-simulation

Other outcome measures

To estimate local recurrence rates

To estimate median Disease Free Survival (DFS)

To estimate median Overall Survival (OS)

+1 more

Side effects data

From 2021 Phase 2 trial • 38 Patients • NCT04529850

68%

Lymphopenia

51%

Nausea

41%

Leukopenia

38%

Anaemia

27%

Neutropenia

27%

Constipation

24%

Decreased Appetite

24%

Hypomagnesamia

22%

Hypokalaemia

22%

Dysphagia

22%

Vomiting

19%

Asthenia

19%

Pyrexia

19%

Dermatitis

19%

Diarrhoea

19%

Radiation Skin Injury

19%

Hypotension

16%

Dyspepsia

16%

Thrombocytopenia

14%

Dry Mouth

14%

Weight Decreased

14%

Oral Pain

11%

Oral Candidiasis

Pneumonia

COVID 19

Dehydration

Tumor Haemorrhage

Renal Failure

Oropharyngeal Pain

Device Related Infection

Stoma Site Infection

Febrile Neutropenia

Leuokopenia

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Open Label Active Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation TherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-modulated radiation therapy (IMRT)

2020

Completed Phase 2

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,629 Total Patients Enrolled

4 Trials studying Lymphedema

210 Patients Enrolled for Lymphedema

Carmen Perez, M.D.Principal InvestigatorNYU Laura and Issac Perlmutter Cancer Center

2 Previous Clinical Trials

410 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial offer age restrictions, excluding those below 65?

"This clinical trial is welcoming individuals who are between the age of 36 and 90."

Answered by AI

Is the recruitment phase of this research project still open?

"Clinicaltrials.gov does not list this study as being currently open for recruitment, with its last revision made on July 7th 2022. While participants are no longer sought here, there are 76 other studies actively pursuing enrolments presently."

Answered by AI

Is it possible for me to be enrolled in this clinical experiment?

"The prerequisites to participate in this research are having lymphedema and being between the ages of 36 and 90. The total number of enrollees is 97 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Prone Accelerated Breast And Nodal IMRT

2009. "Study of Prone Accelerated Breast And Nodal IMRT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02308488.