Bupropion for Fatigue in Breast Cancer Survivors

Recruiting in Palo Alto (17 mi)

+472 other locations

Overseen by Heather S Jim

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Rochester NCORP Research Base

Must not be taking: Bupropion, MAOIs, Antipsychotics, others

Disqualifiers: Renal impairment, Cirrhosis, Seizures, others

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that contain bupropion and certain other medications like MAOIs, linezolid, methylene blue, and anti-psychotic medications before joining. If you are on these, you may need to stop them for a specific period before enrolling.

Is Bupropion safe for humans?

Bupropion, known by various names like Wellbutrin and Zyban, has been used safely in humans for conditions like depression and smoking cessation. Common side effects include dry mouth, insomnia (trouble sleeping), and dizziness, but it is generally considered safe when prescribed by a doctor. ^{1 2 3 4 5}

How does the drug Bupropion differ from other treatments for fatigue in breast cancer survivors?

Bupropion is unique because it is a norepinephrine-dopamine reuptake inhibitor, which means it works by increasing certain chemicals in the brain that help improve mood and energy levels. Unlike other treatments for cancer-related fatigue, which have been disappointing, Bupropion has shown significant improvement in reducing fatigue and enhancing quality of life in cancer patients. ^{6 7 8 9 10}

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.

I finished my cancer treatment 2 months ago but may still be on oral or supportive therapy.

My breast cancer is at an early to mid-stage (I-III).

Exclusion Criteria

I am currently receiving IV treatment for cancer, such as immunotherapy or targeted therapy.

I have a history of seizures.

You have a history of bulimia or anorexia nervosa.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bupropion hydrochloride controlled-release or placebo orally once daily for up to 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bupropion Hydrochloride Controlled-release (Antidepressant)

Trial Overview 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.

Participant Groups

Group I: Arm I (bupropion hydrochloride controlled-release) Experimental Treatment 3 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 Group 3 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 Nearby Select from list below to view details:

Illinois CancerCare-Ottawa Clinic Ottawa, IL

Dublin Methodist Hospital Dublin, OH

Fairview-Southdale Hospital Edina, MN

Illinois CancerCare-Peoria Peoria, IL

More Trial Locations

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base Lead Sponsor

H. Lee Moffitt Cancer Center and Research Institute Collaborator

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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).

3. England pubmed.ncbi.nlm.nih.gov

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.

4. England pubmed.ncbi.nlm.nih.gov

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.

5. China pubmed.ncbi.nlm.nih.gov

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.

6. Thailand pubmed.ncbi.nlm.nih.gov

Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study [2018] Background: Cancer-related fatigue (CRF) is very common and can be experienced at all stages of disease and in survivors. CRF causes patients more distress than pain or nausea and vomiting. Different pharmacologic interventions have been evaluated for the management of CRF. The purpose of this study was to determine the efficacy of bupropion sustained release (SR) as a treatment for fatigue in patients with cancer. Methods: In this randomized, double-blind, placebo-controlled trial, patients with fatigue due to cancer were randomly assigned to either 150mg daily of bupropion SR or matching placebo. The primary endpoint was the changes in average daily fatigue from baseline to week 4 using the Functional Assessment of Chronic Illness-therapy- Fatigue (FACIT-F) questionnaire. Results: 40 patients were randomly assigned to treatment with bupropion SR or placebo (20 in each group). Analysis of covariance (ANCOVA) showed a significant improvement in fatigue and quality of life in the bupropion group compared to baseline (P=0.000). Secondary outcome, including depression, severity of fatigue and performance status didn’t show significant difference between groups. Generally, bupropion SR was tolerated well. Conclusion: Four weeks of 150 mg bupropion SR improve fatigue significantly in cancer patients. Bupropion has potential as an effective and safe pharmaceutical agent for treating CRF.

7. United States pubmed.ncbi.nlm.nih.gov

Bupropion sustained release treatment reduces fatigue in cancer patients. [2017] To demonstrate that bupropion sustained release (SR) can reduce the symptoms of fatigue experienced by cancer patients.

8. United States pubmed.ncbi.nlm.nih.gov

Cancer and Non-cancer Fatigue Treated With Bupropion: A Systematic Review. [2023] Fatigue is a predominant and distressing symptom in cancer and non-cancer conditions for which there is a paucity of recommendations for pharmacological interventions. Bupropion is a novel treatment whose efficacy and safety in the treatment of fatigue are unknown.

9. England pubmed.ncbi.nlm.nih.gov

An open-label study of the effects of bupropion SR on fatigue, depression and quality of life of mixed-site cancer patients and their partners. [2015] This preliminary study investigated whether bupropion sustained release (SR) improved symptomatic fatigue, depression and quality of life in cancer patients and caregiver quality of life. The sample consisted of a prospective open case series of 21 cancer patients, with fatigue and with or without depression at moderate to severe levels, referred for psychiatric assessment from a tertiary care cancer centre. Both patient symptom ratings and caregiver ratings were measured before and after 4 weeks of treatment with the maximally tolerated dose of bupropion in the range of 100-300 mg per day. At trial completion, significant improvement was found for symptoms of fatigue and depression. Subjects were divided into two groups: depressed and non-depressed (based on a cut-off score of 17 on the Hamilton Depression Rating Scale). Both groups reported improvement for fatigue and depressive symptoms. Depressed subjects and their caregivers did not experience any change in quality of life, while the non-depressed subjects and their caregivers reported improvements. Results from this small group of patients suggest that bupropion may have potential as an effective pharmaceutical agent for treating cancer-related fatigue. A randomized, placebo-controlled trial with this medication is indicated.

10. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. [2021] Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.