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Chronic Fatigue clinical trials

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NCT ID: NCT05367245 Recruiting - Clinical trials for Neurocognitive Dysfunction

Ca-Mg Butyrate in GWI

Butyrate
Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.

NCT ID: NCT02865460 Completed - Gulf War Illness Clinical Trials

Coenzyme Q10 Phase III Trial in Gulf War Illness

Start date: July 24, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.

NCT ID: NCT02517151 Recruiting - Clinical trials for Inflammatory Bowel Disease

Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue

MICI_2011-01
Start date: October 2014
Phase: Phase 2
Study type: Interventional

A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.

NCT ID: NCT01926132 Recruiting - Chronic Fatigue Clinical Trials

High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study

Start date: August 2013
Phase: Phase 4
Study type: Interventional

Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.

NCT ID: NCT01902745 Completed - Chronic Fatigue Clinical Trials

Fatigue Reduction Diet

FRD
Start date: November 2013
Phase: N/A
Study type: Interventional

There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. PCRF is associated with decreased quality of life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently, there are few treatment options for PCRF and existing treatment options are associated with significant costs, are a considerable burden on the part of the patient, or have unacceptable side-effects. As such, there is a clear need to conduct studies evaluating the impact of safe, easy to implement and inexpensive treatments for PCRF in BC survivors. Individualized nutritional counseling has been found to be beneficial for decreasing fatigue and improving quality of life in cancer patients receiving treatment.However, there is a dearth of research examining the use of diet for treating fatigue in cancer survivors. Our preliminary data in 40 adult cancer survivors found that fatigue severity was associated with decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g., omega-3 fatty acids, as reported in diet records. However, diet records are often not highly correlated with actual nutrient concentrations in the body and tend to capture short-term dietary habits not long-term patterns. The main objective of this research is to expand upon and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical dietary study we are conducting by examining key nutrient differences in biological samples in the breast cancer survivors. By examining differences in biological samples we will be able to explore three key questions, which will directly influence our future interventional studies: (1) to determine if there are actual differences in concentrations of key nutrients in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what is the effect size and variability of change in key nutrients in body tissue both at baseline and after a dietary intervention.

NCT ID: NCT01281904 Completed - Breast Cancer Clinical Trials

Acupressure for Persistent Cancer Related Fatigue

AcuCrft
Start date: April 2011
Phase: Phase 2/Phase 3
Study type: Interventional

There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects. Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. It also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms. The investigators are conducting a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. The goal of this study is to determine the benefit of acupressure on treating persistent fatigue experience by many patients after completing their cancer treatment. Study patients will be randomized into one of three groups: two different types of acupressure or a standard of care arm. For those participants randomized to receive acupressure, the technique will be taught to them by a study nurse trained by an acupressure specialist. Participants will be asked to perform the acupressure daily over the next six weeks, during which time they will record their fatigue and be asked to wear an activity monitor to have their daily activity levels monitored.

NCT ID: NCT01046370 Completed - Fibromyalgia Clinical Trials

A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia

Start date: October 2009
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM). CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A case series of 33 patients with CFS and ARP reported improvement in 92% of patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However ARP has never been formally studied in CFS. We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will undergo standard clinical treatment which consist of a 2 day self-management program in the Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C group. The ARP group will receive an additional 2.5 hour training surrounding core concepts of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support. The C group will receive only standard care. However they will receive a complementary copy of the ARP program at the end of the study (6 month time point) as a gift for participation in the study. Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36 (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of ARP and any specific difficulties they encountered in the practice of the program.