Treatment for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
West Virginia University Cancer Institute, Morgantown, WV
Breast Cancer+3 More
Eligibility
18+
Female
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Study Summary

This study is evaluating whether pioglitazone can improve muscle fatigue in people with breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Muscle; Fatigue

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 2 weeks.

2 weeks
Body Weight
Up to 6 weeks
Muscle Fatigue
Muscle Gene Expression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Pioglitazone 30mg Dose
1 of 3
Pioglitazone 15mg Dose
1 of 3
No Drug
1 of 3
Active Control

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Pioglitazone 30mg Dose
Drug
Subjects will be given PIO 30mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.
Pioglitazone 15mg Dose
Drug
Subjects will be given PIO 15mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.
No DrugSubjects will be assigned to a no drug control group based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 weeks for reporting.

Who is running the study

Principal Investigator
K. L.
Prof. Kristin Lupinacci, Assistant Professor
West Virginia University

Closest Location

West Virginia University Cancer Institute - Morgantown, WV

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who receive this treatment must not have received any other therapies besides chemotherapy before it. show original
The subject must have a planned surgery date within two weeks of starting treatment. show original
Hemoglobin levels that are within normal institutional limits are typically greater than 10. show original
The serum creatinine level is within the normal institutional range. show original
Subjects must have a confirmed diagnosis of luminal (ER+/PR+ Her2/neu-) breast cancer. show original
Blood glucose levels that are within the normal ranges for a hospital or other similar institution. show original
This means that the liver is not damaged and is functioning normally. show original
This person does not have diabetes and is not currently taking any medications to lower blood glucose levels. show original
People who participate in a study must be able to understand what the study is about and agree to it by signing a written document. show original

Patient Q&A Section

What causes fatigue?

"There is no single cause of fatigue. Physicians and patients need to work together to identify what is causing the symptoms and come up with ways to treat them. A key step in coming up with an appropriate treatment plan is to first exclude medical conditions that could be causing the fatigue." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"Recent findings indicate that cognitive behavior therapy for insomnia is not more effective than a placebo. Due to the small sample size, further research is needed before generalizing the findings to other treatments or conditions." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fatigue?

"There have not been any new discoveries for treating fatigue for the past two decades. However, in the future, treatments targeting specific mechanisms of fatigue and neurological factors could be developed. For example, pharmacological interventions such as selective serotonin reuptake inhibitors (SSRIs) and tramadol could help people manage fatigue by increasing levels of serotonin and decreasing levels of norepinephrine. Neurofeedback technique can help patients improve their capacity to recover from fatigue by enhancing their modulation of neural networks involved in arousal, attention, and vigilance." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing fatigue?

"The data suggest that the chances of developing fatigue depend on the patient's age and the intensity of the fatigue symptomatology. In addition, we found no evidence that fatigue was associated with long-term physical function." - Anonymous Online Contributor

Unverified Answer

How many people get fatigue a year in the United States?

"About 13 million Americans experience [fatigue in any given year] (approximately one in seven adults aged 18 years and older). Fatigue is more common among women than men. Although it is associated with health problems, it is not clear whether fatigue causes these conditions or if they cause fatigue." - Anonymous Online Contributor

Unverified Answer

What are the signs of fatigue?

"Fatigue is a commonly experienced symptom of cancer patients. The severity and duration of fatigue is highly variable between individual patients. A detailed assessment of fatigue including its time course over a week is needed." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of fatigue?

"Fatigue is one of the most common complaints reported by cancer survivors. The causes of fatigue vary among individual patients and depend, at least partially, on the nature of the cancer. In addition to other factors such as sociodemographics, medical comorbidities, physical conditions, psychological stressors, social support, exercise, sleep disorders, and other somatic symptoms, fatigue also appears to be related to depressive symptoms." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Patients with fatigue should ask their doctor if their symptoms are due to an underlying disorder like Ménière's disease. In some cases, fatigue may be caused by the side effects of medications. The use of anti-depressants such as antidepressants might increase fatigue symptoms, especially when taken together with other medications. Patients who take an NSAID (nonsteroidal anti-inflammatory drug) for arthritis might experience excessive bleeding time. A sleep disorder has been found in patients taking antidepressants. If you are looking to join a clinical trial, Power can help you search recent trials by condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Many new therapies are being developed for chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), with most focused on treating ME, and very few on treating CFS. There is significant variability in the results reported in publications regarding therapy efficacy and satisfaction. The authors do not recommend any particular therapy for ME. Patients should be encouraged to continue exercising and avoid overstretching their bodies (e.g., prolonged periods of standing or squatting). They should be carefully monitored for the development of insomnia or other sleep disorders, and be advised about the importance of maintaining a healthy weight and regular physical activity." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fatigue?

"Many people have fatigue, and many treatments are used, including medications, exercise, massage, and therapies like cognitive behavioral therapy, yoga, relaxation, and hypnosis. No single treatment appears to work best, and no one treatment works as well for everyone. It is important to consider all possible treatments before beginning any treatment, because some treatments may worsen the problem rather than helping it." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with fatigue?

"The VAS score was significantly improved by treatment in patients with chronic fatigue syndrome irrespective of fatigue severity. This suggests that improvement in VAS scores may be an objective marker of multidisciplinary treatment effect and may enable evaluation of the impact on HRQoL of CFS." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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