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Cancer-Related Fatigue clinical trials

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NCT ID: NCT02127268 Recruiting - Quality of Life Clinical Trials

Thymosin-α1 in Cancer-Related Fatigue

Start date: April 2014
Phase: Phase 3
Study type: Interventional

Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportion to recent activity and interferes with usual functioning. Compared with general fatigue, CRF have the characteristics of long duration and generally cannot alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and family life, and thus greatly affect the recovery, self-care ability and life quality of patients. Many dates showed that 70%~100% of cancer patients experienced cancer-related fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent years, many clinical trials are carried out; central nervous stimulant, such as methylphenidate; acupuncture, aerobic exercise. All those measures may have certain therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm. Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement, this drug is used for the treatment of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma. T-α1 is able to potentiate the action of cytokines and also reduce the hematological toxicity of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine. In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for cancer-related fatigue in cancer patients who undergo chemotherapy.

NCT ID: NCT01990066 Terminated - Clinical trials for Cancer Related Fatigue

Home Based Exercise Program for Elderly Cancer Patients

Start date: March 2014
Phase: N/A
Study type: Interventional

Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient Problem: Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy? Support: Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010). The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue. Methods: This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care. Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance. The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion). Conclusion: PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.

NCT ID: NCT01926678 Completed - Clinical trials for Cancer Related Fatigue

Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer Survivors

Start date: November 2013
Phase: Phase 2
Study type: Interventional

With approximately 12 million cancer survivors today in the United States alone, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Basic research has shown that activation of the immune system can cause potent changes in behavior including reduced activity, fatigue, and decreased social behavior. Furthermore, research over the last decade has found a relationship between levels of CRF with increased inflammation. Thus, study of therapies that may decrease immune system activation in the setting of CRF represents a possible target for intervention. Massage therapy is one of the fastest growing alternative therapies and has a high rate of acceptance for symptom management among cancer patients. Massage has been shown in smaller studies with cancer patients to modulate the immune system. Moreover, massage has been demonstrated to significantly decrease markers of immune system activation in normal subjects. There are no published randomized controlled trials examining either the role of massage as an intervention primarily for CRF or investigating whether massage related decreases in immune system activation are responsible for improvement in CRF. This proposal investigates the effects of massage therapy on CRF among breast cancer survivors. The investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF compared to a light touch condition and wait list control. The investigators' secondary hypothesis is that SMT will decrease CRF by reducing immune system activation. The investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of life among cancer survivors.

NCT ID: NCT01881516 Not yet recruiting - Lung Cancer Clinical Trials

Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue(CRF)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

we plan to conduct this trial to find out: - If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy? - How about the extent it relieves?the safety and applicability ? - What's the possible influential factor and mechanism ?

NCT ID: NCT01720563 Terminated - Clinical trials for Cancer-related Fatigue

A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy

Start date: December 2012
Phase: Phase 2
Study type: Interventional

Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was higher than the 8-11% reported in the Western populations and was related to oral submucous fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced cancer patients. This study will be investigated the effect of PG2 Injection in relieving the adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of patients with advanced pharyngeal or laryngeal SCCHN.

NCT ID: NCT01720550 Completed - Clinical trials for Cancer-related Fatigue

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

Start date: November 2012
Phase: Phase 4
Study type: Interventional

The objective of this study is to conduct a trial in the spirit of providing as much as possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and safety of different doses of PG2 treatment for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available. Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients between two study arms will then be compared as the basis for efficacy evaluation at the end of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores change from baseline among patients within and between cycles will be included in the secondary efficacy endpoints, and will be compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from EORTC(European Organization) for Research and Treatment of Cancer QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include Karnofsky performance scores, and weight change and its related c-reactive protein level of the patients.

NCT ID: NCT01564394 Completed - Clinical trials for Cancer Related Fatigue

Body Mind Training Project

Start date: October 2011
Phase: N/A
Study type: Interventional

Aim 1: Assess the feasibility, safety and efficacy of a Qigong intervention in elderly prostate cancer survivors. Describe participation, retention, and adherence rates and assess reasons for participation, attrition, and non-adherence. Identify effective recruitment and retention strategies. Ascertain participants' level of satisfaction and additional perceptions of the experimental and control interventions, perceived study burden, study design, and implementation. Aim 2: Provide preliminary data on potential effects of Qigong vs. non-aerobic stretching exercises on fatigue, psychosocial outcomes, and health-related quality of life in preparation for a future R01 application for a larger, definitive randomized controlled trial. Hypothesis: Qigong participants will have improved fatigue levels, quality of life, and related psychosocial and health outcomes compared to those randomized to the non-aerobic stretching group.

NCT ID: NCT01468766 Completed - Breast Cancer Clinical Trials

Effects of a Supervised Progressive Resistance Training With Breast Cancer Patients During Adjuvant Radiotherapy

BEST
Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).

NCT ID: NCT01440621 Completed - Quality of Life Clinical Trials

Modafinil in Cancer Related Fatigue

ModCRF
Start date: August 2010
Phase: Phase 3
Study type: Interventional

Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue which persists even after rest and has significant effects on quality of life. The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with almost every patient on radiotherapy complaining of at-least some magnitude of fatigue. Given that fatigue can affect treatment adherence by patients, it is important to initiate measures to either prevent or mitigate Cancer Related Fatigue. The investigators intend to use modafinil in cancer related fatigue, in view of the fact that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and fibromyalgia. In addition, there have been a few small trials which have hinted towards benefit with the use of modafinil in cancer related fatigue. The investigators have chosen a dose of 100mg/day in the morning, to be compared with placebo. The study arm and the placebo arm will be stratified with respect to age, sex, disease site, baseline performance status. Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.

NCT ID: NCT01228773 Enrolling by invitation - Clinical trials for Cancer-related Fatigue

The Efficacy of Health Navigation® for Cancer-Related Fatigue in Cancer Survivors

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The objective of this study is 1. to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors, which is comprehensive and evidence-based, 2. to evaluate the efficacy for cancer-related fatigue as a result of participating in the Web based, tailored program(Health Navigation®) for 12 weeks 3. to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction with the treatment as a result of participating in the Web based, tailored program(health navigation®) for 12 weeks 4. to assess the efficacy of such intervention compared with usual care in cancer survivors