Combination Therapy for Sleep Disturbance in Cancer
Recruiting in Palo Alto (17 mi)
Overseen bySriram Yennu, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Steroids, Antidepressants, Stimulants, others
Disqualifiers: Psychiatric illness, Sleep disorder, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, you must be on stable doses of any hypnosedative drugs, stimulants, or antidepressants for at least 1 month before joining. You cannot use certain medications like systemic anti-inflammatory drugs, monoamine oxidase inhibitors, tricyclic antidepressants, or anticoagulants.
What data supports the effectiveness of this treatment for sleep disturbance in cancer patients?
Research shows that cognitive behavioral therapy for insomnia (CBT-I) is effective in improving sleep quality and reducing insomnia in cancer patients, with benefits that last even after the treatment ends. This suggests that CBT-I, as part of a combination therapy, could be beneficial for sleep disturbances in cancer patients.12345
Is cognitive behavioral therapy for insomnia (CBT-I) safe for cancer patients?
How is Cognitive Behavior Therapy (CBT) unique for treating sleep disturbances in cancer patients?
Cognitive Behavior Therapy (CBT) is unique for treating sleep disturbances in cancer patients because it focuses on changing negative thought patterns and behaviors that contribute to sleep problems, rather than relying on medication. This approach can be particularly beneficial for cancer patients who may already be taking multiple medications and prefer a non-drug treatment option.89101112
Eligibility Criteria
This trial is for English-speaking cancer patients with sleep issues, stable or no pain, and a life expectancy of over a year. They must be cognitively able to participate and not have severe psychiatric illnesses, certain sleep disorders, or be on specific medications that could interfere with the study.Inclusion Criteria
I have been sleeping poorly for at least 2 weeks.
Ability to communicate in English
My pain is either nonexistent, mild, or stable on my current pain medication.
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Exclusion Criteria
I am not taking MOI, tricyclic antidepressants, or anticoagulants.
I have high anxiety or depression, or I've been on a stable dose of antidepressants for at least 1 month.
I have been on a stable dose of sleep or stimulant medication for at least 1 month.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Cognitive Behavior Therapy (CBT) combined with Bright Light Therapy (BLT), Methylphenidate, and/or Melatonin for 6 weeks
6 weeks
Weekly visits for CBT, daily BLT sessions
Follow-up
Participants are monitored for sleep quality and other symptoms at 3- and 6-months post-intervention
6 months
Treatment Details
Interventions
- Bright Light Therapy (Behavioral Intervention)
- Cognitive Behavior Therapy (Behavioral Intervention)
- Melatonin (Hormone)
- Methylphenidate (Stimulant)
Trial OverviewThe study tests if Cognitive Behavior Therapy (CBT) combined with Bright Light Therapy (BLT), methylphenidate, melatonin, or their placebos can improve sleep quality and reduce fatigue, anxiety, and depression in advanced cancer patients.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Placebo (CLT+ placebo MT + placebo MP with CBT)Experimental Treatment2 Interventions
Patients receive placebo Melatonin (called placebo MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group II: Methylphenidate (CLT + placebo MT + MP with CBT)Experimental Treatment1 Intervention
Patients receive Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks, placebo Melatonin (called placebo MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group III: Combination Therapy (BLT+MT+MP with CBT)Experimental Treatment3 Interventions
Patients receive Melatonin (called MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group IV: Bright light and Melatonin (BLT + MT+ placebo MP with CBT)Experimental Treatment2 Interventions
Patients receive Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, Melatonin (called MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Cognitive Behavior Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:
- Chronic pain management
- Anxiety disorders
- Depressive disorders
🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for:
- Chronic pain management
- Anxiety disorders
- Depressive disorders
- Post-traumatic stress disorder
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for:
- Chronic pain management
- Anxiety disorders
- Depressive disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Predictors of the effect of cognitive behavioral therapy for chronic insomnia comorbid with breast cancer. [2018]Prior studies have supported the efficacy of cognitive behavioral therapy (CBT) for insomnia comorbid with cancer. This article reports secondary analyses that were performed on one of these studies to investigate the predictive role of changes in dysfunctional beliefs about sleep, adherence to behavioral strategies, and some nonspecific factors on sleep changes assessed subjectively and objectively. Fifty-seven women with chronic insomnia comorbid with breast cancer received CBT for insomnia. At posttreatment, subjective sleep improvements were best predicted by higher initial levels of treatment expectancies, but also by decreased dysfunctional beliefs about sleep; the most consistent predictors of polysomnography (PSG) assessed sleep improvements were reduced dysfunctional beliefs about sleep and a higher avoidance of day napping. At 6-month follow-up, subjectively assessed sleep improvements were best predicted by adherence to behavioral strategies, whereas none of the predictors was significantly associated with PSG-assessed sleep improvements. This study gives some support to the importance of targeting erroneous beliefs about sleep and poor sleep habits in the treatment of cancer-related insomnia, but also to the importance of enhancing patients' expectancies for improvement.
Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]Individuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia often persists for years and, when combined with already high levels of cancer-related distress, may place cancer survivors at a higher risk of future physical and mental health problems and poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving sleep. This article presents a comprehensive review of the literature examining the efficacy of CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer patients or survivors. Results suggest that CBT-I is associated with statistically and clinically significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also improve mood, fatigue, and overall quality of life, and can be successfully delivered through a variety of treatment modalities, making it possible to reach a broader range of patients who may not have access to more traditional programs. Future research in this area should focus on the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care.
Cognitive Behavioral Therapy for Sleep in Cancer Patients: Research, Techniques, and Individual Considerations. [2020]This article reviews cognitive behavioral therapy techniques for sleep in the cancer realm. There are unique factors associated with cancer that can exacerbate sleep issues. Stimulus control, sleep restriction, relaxation, paradoxical intention, and cognitive therapy are discussed as specific components of cognitive behavioral therapy for sleep, and practical techniques for implementation are provided. Individual considerations in implementing these techniques are also discussed, including factors such as age, ethnicity, gender, relationship status, educational level, work status, cancer history, pharmacologic treatments, and health beliefs.
Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis. [2022]Insomnia is highly prevalent among patients with breast cancer (BC). Although cognitive behavioral therapy for insomnia (CBT-I) is available in integrative oncology settings, it poses unique challenges for BC survivors. Our review aimed to assess the evidence for the therapeutic effects of CBT-I on insomnia in BC. Randomized controlled trials (RCTs) that included patients/survivors with BC and insomnia, and at least one validated self-report measure of sleep quality were included in the review. Of the 14 included RCTs (total N = 1363), the most common components incorporated in CBT-I interventions were sleep hygiene, stimulus control and sleep restriction. Pooled effect sizes favored CBT-I at post-intervention (Hedges' g = -0.779, 95% CI = -0.949, -0.609), short-term follow-up (within six months, Hedges' g = -0.653, 95% CI = -0.808, -0.498), and long-term follow-up (12 mo, Hedges' g = -0.335, 95% CI = -0.532, -0.139). In sub-analyses, CBT-I had similar effect sizes regardless of potential modifiers (comparison design, delivery formats, etc.). As an integrative oncology intervention, CBT-I is efficacious for reducing insomnia and improving sleep quality in women treated for BC, with medium-to-large effect sizes that persist after intervention delivery ends. Given the variability in the CBT-I components tested in RCTs, future studies should investigate the optimal integration of CBT-I components for managing insomnia during BC survivorship.
Cognitive behavior therapy for insomnia in cancer patients: a systematic review and network meta-analysis. [2022]The aim of this study was to examine the most effective delivery format of cognitive behavioral therapy for insomnia (CBT-I) on insomnia in cancer patients.
Light enhanced cognitive behavioral therapy for insomnia and fatigue during chemotherapy for breast cancer: a randomized controlled trial. [2022]Sleep problems are common during chemotherapy for breast cancer (BC). We evaluated whether combined brief cognitive behavioral and bright light therapy (CBT-I + Light) is superior to treatment as usual with relaxation audio (TAU+) for insomnia symptoms and sleep efficiency (primary outcomes).
A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. [2022]This review examined the efficacy of cognitive behavior therapy for insomnia (CBT-I) in people diagnosed with cancer. Studies were identified through November 2014 using multiple databases, clinical trial records, and bibliography searches. Inclusion was limited to randomized controlled trials of CBT-I conducted in individuals with a cancer diagnosis who had clinically relevant insomnia. The primary outcome variable was sleep efficiency (SE) as measured by sleep diary. Eight studies including data from 752 cancer survivors met inclusion criteria. CBT-I resulted in a 15.5% improvement in SE relative to control conditions (6.1%) from pre- to post-intervention, with a medium effect size (ES: d = 0.53). Overall, sleep latency was reduced by 22 min with an ES of d = 0.43, compared to a reduction of 8 min in the control conditions. Wake after sleep onset was reduced by 30 min with an ES of d = 0.41, compared to 13 min in the control conditions. Large effect sizes were observed for self-reported insomnia severity (d = 0.77) for those patients who received CBT-I, representing a clinically relevant eight point reduction. Effects were durable up to 6 mo. The quality of the evidence supports a strong recommendation for the use of CBT-I among cancer survivors.
Symposium theme: a conceptual approach to integrated cancer therapy. [2019]The term "integrated cancer therapy" reflects treatment in which the decision making process is disease oriented rather than specialty or modality oriented. Two phases of integrated cancer therapy can be defined, the first being a determination of the treatment failure mechanisms for each of the variable clinical presentations of specific neoplasms. The second phase, integration of the available treatment modalities, is aimed at neutralizing the inherent weakness of any one method with the strength of other methods. A general strategic approach is presented.
Associating Immunotherapy and Targeted Therapies: Facts and Hopes. [2023]Immune-checkpoint inhibitors (ICI), particularly inhibitors of the PD-1/PD-L1 (Programmed Death 1/Programmed Death-Ligand 1) axis, have modified the management of many types of cancer over the last 10 years. However, both intrinsic and acquired resistance are major clinical issues with these therapies, and only a few patients are cured by ICI monotherapy. To overcome resistance, the concept of combining ICIs with other therapies is emerging and supported by many preclinical trials. Besides associations of ICIs with chemotherapy or radiotherapy, now used in clinical practice, some targeted therapies have also been reported to influence immune response of patients against cancer cells, thus showing potential synergy with ICIs. In this review, we describe the preclinical and clinical advances to date in the use of these combination strategies.
Combinatorial Approach to Improve Cancer Immunotherapy: Rational Drug Design Strategy to Simultaneously Hit Multiple Targets to Kill Tumor Cells and to Activate the Immune System. [2020]Cancer immunotherapy, including immune checkpoint blockade and adoptive CAR T-cell therapy, has clearly established itself as an important modality to treat melanoma and other malignancies. Despite the tremendous clinical success of immunotherapy over other cancer treatments, this approach has shown substantial benefit to only some of the patients while the rest of the patients have not responded due to immune evasion. In recent years, a combination of cancer immunotherapy together with existing anticancer treatments has gained significant attention and has been extensively investigated in preclinical or clinical studies. In this review, we discuss the therapeutic potential of novel regimens combining immune checkpoint inhibitors with therapeutic interventions that (1) increase tumor immunogenicity such as chemotherapy, radiotherapy, and epigenetic therapy; (2) reverse tumor immunosuppression such as TAMs, MDSCs, and Tregs targeted therapy; and (3) reduce tumor burden and increase the immune effector response with rationally designed dual or triple inhibitory chemotypes.
Cancer immunotherapy: Strategies for personalization and combinatorial approaches. [2022]The results of recent clinical trials using novel immunotherapy strategies such as immune checkpoint blockade and adoptive T-cell therapy approaches including CAR T-cell therapy have clearly established immunotherapy as an important modality for the treatment of cancer besides the traditional approaches of surgery, radiotherapy, and chemotherapy or targeted therapy. However, to date immunotherapy has been shown to induce durable clinical benefit in only a fraction of the patients. The use of combination strategies is likely to increase the number of patients that might benefit from immunotherapy. Indeed, over the last decade, the characterization of multiple immune resistance mechanisms used by the tumor to evade the immune system and the development of agents that target those mechanisms has generated a lot of enthusiasm for cancer immunotherapy. But a critical issue is to determine how best to combine such agents. This review will focus on novel immunotherapy agents currently in development and discuss strategies to develop and personalize combination cancer immunotherapy strategies.
New Immunotherapy and Lung Cancer. [2018]Recent research on the relationship between the immune system and cancer has revealed the molecular mechanisms by which cancer cells co-opt certain T cell receptors which block the cytotoxic response to defend themselves from the antitumor immune attack. These findings have helped identify specific targets (T cell receptors or their corresponding ligands) for the design of monoclonal antibodies that can unlock the immune response. These drugs, known as immune checkpoint inhibitors, have shown efficacy in metastatic melanoma and kidney cancer, and have been successfully tested in non-small cell lung cancer in recent trials. Immune checkpoint inhibitors were included in clinical practice as a second-line option after an initial chemotherapy (CT) regimen, and in the last year positive results have been reported from randomized trials in which they were compared in first line with standard CT. Responses have been surprising and durable, but less than 20%-25% in unselected patients, so it is essential that factors predicting efficacy be identified. One such biomarker is PD-L1, but the different methods used to detect it have produced mixed results. This non-systematic review discusses the results of the latest trials, the possibilities of incorporating these drugs in first-line regimens, the criteria for patient selection, adverse effects, and the prospects of combinations with conventional treatment modalities, such as CT, radiation therapy, and antiangiogenic agents.