Bupropion for Fatigue in Breast Cancer Survivors

Recruiting at 548 trial locations

Overseen By Sherri Ladd

Age: 18+

Sex: Any

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

422 Participants Needed

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. Cancer and its treatment can cause fatigue. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. It belongs to the family of drugs called antidepressants and works by increasing certain types of activity in the brain. Bupropion may reduce cancer-related fatigue by causing changes in inflammation and stress hormones.

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}

Research Team

Heather S Jim

Principal Investigator

University of Rochester NCORP Research Base

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.

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

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 4 Interventions

Patients receive bupropion hydrochloride controlled-release PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study.

Group II: Arm II (placebo) Placebo Group 4 Interventions

Patients receive placebo PO QD for up to 13 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout study.

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

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Severe fatigue affects about 25% of breast cancer survivors, and this fatigue is negatively correlated with quality of life factors such as general well-being, functioning, and mental health, supported by moderate to strong evidence from 57 studies.

Psychological interventions targeting fatigue in breast cancer survivors should focus on addressing emotional problems, sleep disturbances, physical activity, pain, coping strategies, and social support, as these factors have moderate to strong evidence linking them to fatigue levels.

NCBI (Pubmed)

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. Abrahams, HJG., Gielissen, MFM., Verhagen, CAHHVM., et al.[2019]

In a study of 68 long-term breast cancer survivors, 34% reported poor to moderate attention function, highlighting a significant incidence of attentional fatigue among this group.

Sleep disturbance was found to significantly predict attentional fatigue, explaining 16% of the variance, suggesting that addressing sleep issues could help improve attention in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Factors Associated With Attentional Fatigue in Working Long-term Breast Cancer Survivors. Crouch, A., Von Ah, D.[2018]

This study aims to evaluate a behavioral intervention designed to reduce fatigue in women undergoing radiotherapy for early breast cancer, addressing a significant side effect experienced by about 40% of patients.

The trial will involve 70 women, with assessments at multiple points during and after treatment to measure the feasibility of the intervention and gather insights on participants' experiences, which will help refine future studies.

NCBI (Pubmed)

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. Courtier, N., Gaze, S., Armes, J., et al.[2022]

In a study of 315 breast cancer survivors undergoing endocrine therapy, 60% reported experiencing cancer-related fatigue (CRF), highlighting its prevalence and impact on daily life.

Factors such as body mass index (BMI), clinical stage, menopausal status, duration of therapy, physical activity, and diet were associated with the severity of CRF, suggesting that lifestyle modifications may help manage fatigue in these patients.

NCBI (Pubmed)

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. Huang, X., Zhang, Q., Kang, X., et al.[2021]

A study involving 160 breast cancer patients showed that solution-focused brief therapy (SFBT) significantly reduced cancer-related fatigue (CRF) after surgery and chemotherapy, with fatigue levels returning to baseline after the intervention.

In contrast, patients receiving only routine nursing care experienced worsening fatigue over time, highlighting SFBT as an effective non-pharmacological approach to improve quality of life for breast cancer survivors.

NCBI (Pubmed)

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. Liu, W., Geng, H., Ma, L., et al.[2022]

In a randomized, double-blind, placebo-controlled trial involving 40 cancer patients, bupropion sustained release (SR) significantly improved fatigue levels after four weeks of treatment compared to baseline, indicating its efficacy in managing cancer-related fatigue (CRF).

Bupropion SR was well-tolerated by patients, suggesting it is a safe option for alleviating fatigue in cancer patients, although it did not show significant differences in secondary outcomes like depression or performance status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study Ashrafi, F., Mousavi, S., Karimi, M.[2018]

In a case series of 15 cancer patients treated with bupropion sustained release (SR) for up to 2 years, 13 patients experienced significant improvement in fatigue symptoms within 2 to 4 weeks.

Most patients tolerated bupropion SR well, with only minor side effects reported, suggesting it may be a safe option for managing fatigue in cancer patients, although further controlled studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupropion sustained release treatment reduces fatigue in cancer patients. Cullum, JL., Wojciechowski, AE., Pelletier, G., et al.[2017]

Bupropion may effectively reduce fatigue in both cancer and non-cancer patients, as indicated by six out of seven studies involving a total of 584 participants, although the studies varied in quality and sample size.

The treatment was generally safe, with no major adverse effects reported, but the authors caution that more rigorous, high-quality randomized trials are needed to confirm these preliminary findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer and Non-cancer Fatigue Treated With Bupropion: A Systematic Review. Correa-Morales, JE., Cuellar-Valencia, L., Mantilla-Manosalva, N., et al.[2023]

In a preliminary study of 21 cancer patients, bupropion sustained release (SR) significantly improved symptoms of fatigue and depression after 4 weeks of treatment, suggesting its potential effectiveness for cancer-related fatigue.

While both depressed and non-depressed patients reported improvements in fatigue and depressive symptoms, only non-depressed patients and their caregivers experienced enhancements in quality of life, indicating that further research is needed to explore these effects comprehensively.

NCBI (Pubmed)

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. Moss, EL., Simpson, JS., Pelletier, G., et al.[2015]

This study is a randomized, double-blind, placebo-controlled trial involving 422 disease-free breast cancer survivors to rigorously test the efficacy and tolerability of bupropion for alleviating cancer-related fatigue.

If successful, bupropion could provide a safe and effective treatment option for cancer-related fatigue, potentially improving quality of life for survivors, as it targets both inflammation and the hypothalamic-pituitary-adrenal axis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. Jim, HSL., Hoogland, AI., Han, HS., et al.[2021]

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]

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

Incidence and Factors Associated With Attentional Fatigue in Working Long-term Breast Cancer Survivors. [2018]

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]

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]

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]

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

Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study [2018]

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

Bupropion sustained release treatment reduces fatigue in cancer patients. [2017]

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

Cancer and Non-cancer Fatigue Treated With Bupropion: A Systematic Review. [2023]

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]

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

A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures. [2021]