Bupropion for Fatigue in Breast Cancer Survivors
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Rochester NCORP Research Base
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This phase III trial studies how well bupropion works in reducing cancer related fatigue in cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in cancer survivors.
Is the drug Bupropion Hydrochloride a promising treatment for fatigue in breast cancer survivors?The information provided does not directly address the effectiveness of Bupropion Hydrochloride for fatigue in breast cancer survivors. However, it highlights the importance of addressing fatigue through various interventions, such as psychological therapies, which have shown promise in improving quality of life and reducing fatigue. Further research would be needed to determine if Bupropion Hydrochloride specifically is a promising treatment for this purpose.4781214
What safety data is available for Bupropion in treating fatigue in breast cancer survivors?The provided research does not contain specific safety data for Bupropion or its other names in treating fatigue in breast cancer survivors. The studies focus on the relationship between fatigue and quality of life, psychological factors, and interventions for fatigue in breast cancer survivors, but do not address the safety of Bupropion.6891013
What data supports the idea that Bupropion for Fatigue in Breast Cancer Survivors is an effective drug?The available research does not provide any data on Bupropion for Fatigue in Breast Cancer Survivors. Instead, it focuses on other treatments for breast cancer, such as vinorelbine and 5-fluorouracil, which are used in chemotherapy. These studies discuss their effectiveness and side effects in treating breast cancer, but do not mention Bupropion or its use for fatigue in breast cancer survivors.123511
Do I have to stop taking my current medications?The trial does not specify if you need to stop all current medications, but you cannot take bupropion, MAOIs, linezolid, methylene blue, or anti-psychotic medications before joining. If you're on these, you must stop them 1-2 weeks before enrolling.
Eligibility Criteria
This trial is for stage I-III breast cancer survivors who are at least 18 years old, have finished their main treatments like surgery or chemo at least two months ago, and are not currently pregnant or breastfeeding. They must be experiencing moderate to severe fatigue and cannot have certain conditions like renal impairment, a history of seizures, eating disorders, or specific medication sensitivities.Inclusion Criteria
I have felt moderate to severe fatigue in the last week.
My breast cancer is at an early to mid-stage (I-III).
My cancer is not getting worse or is undetectable.
My worst fatigue level last week was moderate to severe.
I am 18 years old or older.
I have been diagnosed with cancer.
Exclusion Criteria
I am currently receiving IV treatment for cancer, such as immunotherapy or targeted therapy.
I have a history of seizures.
I am currently taking medication that contains bupropion.
I have a history of kidney problems.
I have a history of severe liver disease.
Treatment Details
The study is testing if Bupropion Hydrochloride Controlled-release can reduce fatigue in breast cancer survivors compared to a placebo (a substance with no active drug). Participants will also complete quality-of-life assessments and questionnaires to measure the impact on their fatigue levels.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (bupropion hydrochloride controlled-release)Experimental Treatment3 Interventions
Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo)Placebo Group3 Interventions
Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity.
Bupropion Hydrochloride Controlled-release is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
🇺🇸 Approved in United States as Wellbutrin for:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
🇪🇺 Approved in European Union as Zyban for:
- Smoking cessation
🇨🇦 Approved in Canada as Wellbutrin XL for:
- Major depressive disorder
- Seasonal affective disorder
🇯🇵 Approved in Japan as Bupropion for:
- Depression
🇨🇭 Approved in Switzerland as Wellbutrin SR for:
- Major depressive disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
Illinois CancerCare-Ottawa ClinicOttawa, IL
Dublin Methodist HospitalDublin, OH
Fairview-Southdale HospitalEdina, MN
Illinois CancerCare-PeoriaPeoria, IL
More Trial Locations
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Who is running the clinical trial?
University of Rochester NCORP Research BaseLead Sponsor
H. Lee Moffitt Cancer Center and Research InstituteCollaborator
National Cancer Institute (NCI)Collaborator
References
A phase II, multicentre, UK study of vinorelbine in advanced breast cancer. [2019]Thirty-four evaluable patients were treated with vinorelbine, a novel, semisynthetic vinca alkaloid, as first-line chemotherapy for advanced breast cancer. They received vinorelbine 25 mg m-2 i.v. given weekly for a maximum of 16 cycles. Two patients achieved a complete remission and 15 a partial remission, giving a response rate of 17/34 (50%; 95% CI of 34-66%); median response duration was 5.8 months. The median progression-free interval was 4.4 months and median survival 9.9 months. Treatment was generally well tolerated. Fatigue was the most common side-effect. The main reason for dose adjustments was myelosuppression; 68% of patients had WHO grade 3 or 4 neutropenia and there was one death attributed to neutropenic sepsis. Nausea/vomiting and neuropathy were mild and alopecia was uncommon. This study confirms vinorelbine as a highly active, well-tolerated agent in advanced breast cancer worthy of evaluation in combination chemotherapy regimens.
5'-deoxy-5-fluorouridine, medroxyprogestrone acetate and mitoxantrone hydrochloride for advanced or recurrent breast cancer. [2019]In treating advanced or recurrent breast cancer, anthracycline-containing chemotherapy is used for palliation and to maintain quality of life. However, there are several drawbacks including therapeutic failure and cardiotoxicity. We evaluated the efficacy and toxicity of combination chemotherapy with 5'-deoxy-5-fluorouridine (5'-DFUR), medroxyprogestrone acetate (MPA) and mitoxantrone hydrochloride (MIT).
Developments in cytotoxic chemotherapy: advances in treatment utilising vinorelbine. [2019]Vinorelbine is a third generation vinca alkaloid which has been in clinical development for 15 years. Recent exploration of its pre-clinical activity has revealed unexpected evidence of potential synergy with taxane compounds and early clinical results support the suggestion of enhanced efficacy particularly in breast cancer. The initial studies establishing the clinical activity of vinorelbine in breast cancer and non-small cell lung cancer have been extended to encompass a thorough evaluation of its contribution to combination chemotherapy for these disorders. In the treatment of breast cancer useful activity has been established for vinorelbine in combination with anthracyclines, anthracenediones, antimetabolites and the taxanes; additive toxicity is not a limiting factor. The activity of vinorelbine in the treatment of non-small cell lung cancer is significantly extended by incorporation into schedules utilising cisplatin and other agents. Vinorelbine has also demonstrated useful activity in the treatment of a wide range of other malignancies including prostatic carcinoma, multiple myeloma, cancer of the ovary, cervix and head and neck and malignant lymphomas.
Fatigue and quality of life: lessons from the real world. [2022]The impact of fatigue on the quality of life of oncology patients is substantial and under-recognized. Fatigue in these patients may begin with a simple decrease in physical activity, but can progress to include a wide range of negative effects that often culminate in patients feeling out of control, lonely, and isolated. In general, surviving cancer patients experience some limitations after the end of treatment but ultimately attain a reasonably good level of functioning. An examination of subpopulations and further analyses of data suggest, however, four different recovery patterns. Patients may: A) improve in their functioning, reach a plateau at approximately year 2 or 3, and then remain at relatively high levels of functioning; B) improve initially, but deteriorate again after year 2 or 3, never reaching the normal stage; C) improve, returning to normal; or D) have a very mixed pattern of high levels of fatigue that is, to date, very difficult to interpret. Disturbingly, 60% of the survivors in our population of patients with Hodgkin's disease, who were treated in recent trials of the German Hodgkin Study Group and the European Organization for Research and Treatment of Cancer Lymphoma Group, had medium to high levels of fatigue after 5 cancer-free years. Investigations are essential to determine the current status of long-term survivors in more detail and to link that status to conditions observed during the treatment of acutely ill patients.
Vinorelbine and 5-fluorouracil bolus and/or continuous venous infusion plus levofolinic acid as second-line chemotherapy for metastatic breast cancer: an analysis of results in clinical practice of the Gruppo Oncologico Italia Meridionale (GOIM). [2018]This retrospective study evaluated the activity and toxicity profile of a regimen of vinorelbine and 5-fluorouracil with levofolinic acid, given to a large series of patients with recurrent or refractory metastatic breast cancer after first-line chemotherapy.
Factors associated with cancer-related fatigue in breast cancer patients undergoing endocrine therapy in an urban setting: a cross-sectional study. [2021]Fatigue is prevalent in breast cancer survivors and has profound effects on daily life. The interference of fatigue with endocrine therapy may be difficult to separate. This study investigates the prevalence and severity of fatigue and identifies the demographic, clinical, and lifestyle factors associated with cancer-related fatigue (CRF) in breast cancer patients undergoing endocrine therapy in an urban area.
The efficacy of Internet-based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial. [2018]Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU).
The relationship of fatigue in breast cancer survivors with quality of life and factors to address in psychological interventions: A systematic review. [2019]Severe fatigue occurs in one in four breast cancer survivors (BCS). Quality of life (QOL) and psychological factors are important in fatigue-oriented interventions for BCS, but an up-to-date overview is lacking. The aims of this review were to (i) provide a comprehensive overview of the relationship of fatigue with QOL and factors that can be addressed in psychological interventions for fatigue in BCS and (ii) determine the strength of evidence for these relationships. A systematic literature search was conducted to find studies on fatigue in BCS who had completed curative breast cancer treatment. Fatigue-related factors of 57 eligible studies were extracted and the level of evidence was determined. Factors regarding QOL (ie, general QOL, functioning, work ability, and mental health) had a negative relationship with fatigue (moderate to strong evidence). Target factors for psychological interventions were divided into the subcategories emotional problems, sleep disturbances, physical activity, pain, coping with cancer, dysfunctional cognitions, and social support. Moderate to strong evidence appeared for a relationship of fatigue with depressive symptoms, anxiety, distress, sleep disturbances, lower physical activity levels, pain, difficulties with coping with cancer, and catastrophizing about symptoms. These factors are points of attention for existing and future psychological interventions for fatigue in BCS.
Incidence and Factors Associated With Attentional Fatigue in Working Long-term Breast Cancer Survivors. [2018]The purpose of this study was to examine the incidence of attentional fatigue and the relationship between sleep disturbance and attentional fatigue in working long-term breast cancer survivors (BCS).
ACTIVE - a randomised feasibility trial study protocol of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer: study protocol. [2022]Fatigue is rated as the most distressing side effect of radiotherapy treatment for curable breast cancer. About four in ten women treated experience fatigue, which can last for years after treatment. The impact of this debilitating tiredness is loss of independence and impaired physical and mental function. Our study will take a behavioural intervention with demonstrated effect in treating fatigue in a mixed group of chemotherapy patients and adapt it for women undergoing radiotherapy for early breast cancer. The purpose of this trial is to evaluate the feasibility of delivering the intervention in the radiotherapy pathway for patients at a high risk of fatigue and to explore participants' experiences of the trial and intervention.
The NAME trial: a direct comparison of classical oral Navelbine versus Metronomic Navelbine in metastatic breast cancer. [2020]Chemotherapy for metastatic breast cancer (MBC) is in general given in cycles of maximum tolerated doses to potentially maximize the therapeutic outcome. However, when compared with targeted therapies for MBC, conventional and dose intensified chemotherapy has caused only modest survival benefits during the recent decades, often compromising the quality of life considerably. Navelbine is an antineoplastic agent that has shown efficacy in the treatment of a variety of cancer types, including breast cancer. Early clinical trials involving both breast cancer and lung cancer patients suggest that metronomic dosing of Navelbine might be at least as effective as classical administration (once weekly, etc.). The NAME trial compares these two strategies of Navelbine administration in MBC patients.
Targeted self-management limits fatigue for women undergoing radiotherapy for early breast cancer: results from the ACTIVE randomised feasibility trial. [2022]The ACTIVE intervention uses a novel fatigue propensity tool to target a behavioural fatigue self-management programme for women undergoing radiotherapy for early breast cancer. We assess feasibility and outcomes for ACTIVE.
Effect of the solution-focused brief therapy on cancer-related fatigue in breast cancer patients under adjuvant chemotherapy: a randomized trial. [2022]Cancer-related fatigue (CRF) is a severe symptom in breast cancer survivors. We aimed to explore the effects of the solution-focused brief therapy (SFBT) on CRF in breast cancer patients after lumpectomy or mastectomy under adjuvant chemotherapy.
The effect of cognitive behavioural therapy integrated with activity pacing on cancer-related fatigue, depression and quality of life among patients with breast cancer undergoing chemotherapy in Ethiopia: A randomised clinical trial. [2023]Fatigue is a common symptom experienced by 80% of individuals who receive chemotherapy and is one of the major factors that affect quality of life (QoL) of patients with breast cancer. Our study aimed to assess the effect of cognitive behavioural therapy integrated with activity pacing (CBT-AP) on cancer-related fatigue among patients with breast cancer undergoing chemotherapy. A parallel-group, randomised controlled trial was conducted. Severely fatigued patients were randomly assigned to the CBT-AP or usual care (UC) groups using a computer-generated random sequence. The new intervention was designed for seven sessions: three 2-hour face-to-face and four 30-minute telephone sessions. The primary outcome (fatigue severity) and the secondary outcomes (depression and QoL) were assessed at the end of the intervention and after 3 months. The data were analysed by repeated measures analyses of covariance (RM-ANCOVA). CBT-AP had a significant time effect (P < .001, ηp2  = 0.233) in reducing fatigue from baseline (adjusted mean = 7.48) to the end of the intervention (adjusted mean = 6.37) and the 3-month follow-up (adjusted mean = 6.54). Compared to the UC group, the CBT-AP group had lower fatigue and depression scores, and higher global health status scores. The group × time interaction revealed a significant reduction in fatigue and depression in the CBT-AP group compared to the UC group. Therefore, CBT-AP appears to be effective in reducing fatigue and depression and improving QoL in patients with breast cancer undergoing chemotherapy. It is highly recommended to integrate a CBT-AP intervention in routine cancer care.