CSMC, IIT2022-14-Asher-HELMT, Ph pilot, blinded, CRCI, photobiomodulation vs. placebo

Purpose of Study

What is the Purpose of this Study?

2.1 Primary Objectives 2.1.1 To assess the effect size of a 6-week Photobiomodulation intervention has on cognitive symptoms in cancer patients with cancer-related cognitive impairment, as measured by changes in scores on the PROMIS Cognitive Function-Short-Form 8a 2.2 Secondary Objectives 2.2.1 To assess the impact a 6-week Photobiomodulation intervention has on cognitive abilities in cancer survivors 2.2.2 To assess the impact a 6-week Photobiomodulation intervention has on quality of life in cancer survivors 2.2.3 To assess the impact a 6-week Photobiomodulation intervention has on depression in cancer survivors 2.2.4 To assess the impact a 6-week Photobiomodulation intervention has on anxiety in cancer survivors 2.3 Exploratory Objectives 2.3.1 To assess the feasibility of a 6-week Photobiomodulation intervention 2.3.2 To assess the feasibility of completely surveys at 3 research visits throughout the study


Study Eligibility

Eligibility


  • * Adults ≥ 18 years
  • * Previous diagnosis of stage I-III non-central nervous system solid tumor malignancy, Hodgkin, or Non-Hodgkin lymphoma
  • * Completed cancer treatment (chemotherapy and/or radiation) more than 6 months ago but less than 5 years ago (Current concurrent endocrine therapy, anti-HER-2 therapy allowed, or other stable maintenance therapies (such as rituximab) will be allowed.
  • * Self-reported cognitive complaints (score ≤ 54 on the Functional Assessment of Cancer Therapy-Cognition, Version 3, Perceived Cognitive Impairment subscale)
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Study Sites

Where can I participate?



CS Cancer at Cedars-Sinai Medical Center : Ana Martin

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2022-14-ASHER-HELMET: Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment

Study Details
Disease Type/Condition

Anus, Bones and Joints, Breast, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Hodgkin Lymphoma, Kaposi's Sarcoma, Kaposi's sarcoma, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung, Lymphoid Leukemia, Melanoma, Mycosis Fungoides, Non-Hodgkin Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Urinary Bladder

Principal Investigator
1

Asher, Arash

Co-Investigators

Philip Chang

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

STUDY00002802

ClinicalTrials.gov ID

NCT05855694

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Name

Ana Martin

Email

ana.martin@cshs.org
Study Detail
Disease Type/Condition

Anus, Bones and Joints, Breast, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Hodgkin Lymphoma, Kaposi's Sarcoma, Kaposi's sarcoma, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung, Lymphoid Leukemia, Melanoma, Mycosis Fungoides, Non-Hodgkin Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Urinary Bladder

Principal Investigator

Asher, Arash

Age Group

Adult

Phase

N/A (Cancer Control)

IRB Number

IIT2022-14-ASHER-HELMET

ClinicalTrials.gov ID

NCT05855694

Key Eligibility
ClinicalTrials.gov

Contact
Name

Ana Martin

Email
ana.martin@cshs.org