Multiple Myeloma Clinical Trial

Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)

Summary

Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from three medical centers. The light will be administered by a small, personal light glasses daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF.

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Full Description

The proposed multi-site randomized controlled trial (RCT) will investigate a novel intervention, systematic light exposure (sLE), to treat cancer-related fatigue (CRF) among Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) following autologous stem cell transplantation (ASCT). Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most common cancer side effect and can severely interfere with activities of daily living long after completion of all medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF (including yoga, cognitive behavior therapy, hypnosis, and exercise) have also been studied; however, such interventions are costly to implement and involve significant patient burden. sLE is a low-cost, low- burden intervention that we have found to have beneficial effects for patients post-ASCT. The investigators initial randomized trial for CRF found that certain light exposure was associated with clinically significant reductions in fatigue (effect size d=0.98) More relevant to the proposed research is the preliminary investigation with sLE to treat CRF in MM and DLBCL which found that patients receiving certain sLE reported significantly less fatigue ( p=0.052). The proposed RCT will test the efficacy of sLE on CRF. It will also assess the effect of sLE on sleep, depressive symptoms, and both activity and cortisol circadian rhythms as these related processes have been hypothesized as possible mechanisms of

sLE's effects on CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers.

The light will be administered by light glasses for 4 weeks. Outcomes will be assessed at five separate time points including baseline and follow-ups.

The researchers' preliminary research has established the feasibility of this proposal. Moreover, in the preliminary research, 75% of participants completed the preliminary trial and data from the light box compliance meters showed that participants used the light boxes 80% of the days that treatment was scheduled. A large sample of fatigued MM and DLBCL ASCT survivors has been identified. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013). It will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among cancer survivors treated with ASCT; 2) focus on a distinct, homogenous patient population (MM and DLBCL ASCT survivors); 3) include only survivors who experience clinical levels of CRF; and 4) address possible mechanisms. This RCT will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces CRF.

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Eligibility Criteria

Inclusion Criteria:

In remission (partial to complete remission) verified by medical records
With a history of ASCT as treatment for hematological malignancies such as MM, DLBCL, and related diseases and who are between one month and five years post-transplant

AND:

-With a score equal to or less than 33 on the FACIT-Fatigue scale (see below)

AND:

-Who are currently over age 18 and were at least age 16 at the time of ASCT

Exclusion Criteria:

COVID diagnoses (active COVID-19) at the time of recruitment
Under age 18
Pregnancy
Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm> Severe sleep disorders (e.g. Narcolepsy)
Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, glaucoma that causes visual impairment, macular degeneration, blindness, pupil dilation problems or retina damage)
Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
Currently employed in night shift work
Previous use of light therapy to alleviate fatigue or depressive symptoms
Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
Severe Psychiatric disorders assessed by the Psychoticism-Paranoia Screener
Secondary cancer diagnosis (prior or current) within the past 5 years
Plans to travel across meridians during the study

To decrease sample heterogeneity (consistent with JNCI, 2013 recommendations), allogeneic-HSCT survivors will not be eligible for the study.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

194

Study ID:

NCT03119363

Recruitment Status:

Completed

Sponsor:

Icahn School of Medicine at Mount Sinai

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There are 3 Locations for this study

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Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

194

Study ID:

NCT03119363

Recruitment Status:

Completed

Sponsor:


Icahn School of Medicine at Mount Sinai

How clear is this clinincal trial information?

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