Quality-of-Life Assessment for Anatomic Stage IA Breast Cancer AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kennedy Health Systems-Cancer Center, Sewell, NJ
Anatomic Stage IA Breast Cancer AJCC v8+22 More
Quality-of-Life Assessment - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a chemotherapy drug may help reduce chemotherapy-induced peripheral neuropathy in patients with breast cancer.

See full description

Eligible Conditions

  • Anatomic Stage IA Breast Cancer AJCC v8
  • Invasive Breast Carcinoma
  • Prognostic Stage 1 Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Prognostic Stage 2 Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anatomic Stage IA Breast Cancer AJCC v8

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome, 6 secondary outcomes, and 3 other outcomes in patients with Anatomic Stage IA Breast Cancer AJCC v8. Measurement will happen over the course of Baseline.

Baseline
Association between Social economic determinants of health and treatment completion
Association between social determinants of health and FACT-Ntx HRQoL scores
Social economic determinants of health and FACT-Ntx neurotoxicity scores
Validation of a prior germline predictor of paclitaxel-induced peripheral neuropathy (Arm A)
Year 3
Grade 2-4 taxane-induced peripheral neuropathy (TIPN)
Health-related quality of life (HRQoL) between both arms
PRO-CTCAE scores of numbness, tingling, and general pain between both arms
Patient-related outcome (PRO)-based neurotoxicity
Physical function between both arms
Month 6
Financial toxicity between both arms

Trial Safety

Safety Progress

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

Other trials for Anatomic Stage IA Breast Cancer AJCC v8

Trial Design

2 Treatment Groups

Arm A (paclitaxel)
1 of 2
Arm B (docetaxel)
1 of 2
Experimental Treatment

This trial requires 249 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A (paclitaxel)Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
Arm B (docetaxel)Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Kennedy Health Systems-Cancer Center - Sewell, NJ

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must not have received prior taxane therapy, or prior/concurrent platinum therapy. show original
for the current cancer Patients who have had other cancers in the past are eligible for the study, as long as they haven't received taxane, platinum, or vinca alkaloid therapy for their current cancer. show original
Patients must not have nerve damage in their extremities. show original
on 2 consecutive tests If a patient's bilirubin level is above the upper limit of normal on two consecutive tests, the patient is not allowed to be a patient. show original
For most people, docetaxel given every 3 weeks for 4-6 cycles, or weekly paclitaxel for 4 cycles is an effective treatment. show original
before participating in a clinical trial show original
The study is for women who have been recently diagnosed with invasive breast cancer show original
ECOG performance status 0-1 means that the person is active and able to carry out all normal activities, with no significant limitations. show original
NOTE: Recommended therapies for various therapy regimens are outlined based on estrogen receptor (ER)/progesterone receptor (PR)/HER2 and nodal status. Where there are options, the treating physician will choose a regimen best fitted for that patient. If the physician does not feel any of the regimens are the best fit for the patient, the patient should not be enrolled. Physicians will also document why a regimen was felt to be inappropriate when an option
Patients must identify as one of the following: black, African American, or of African descent show original

Patient Q&A Section

What is peripheral nervous system diseases?

"The most common peripheral nervous system disease in adult dogs is paroxysmal idiopathic paralysis. Most of the time, the paroxysmal attacks occur more than three times a week. Paroxysmal paralysis is more common in dogs than cats. Most cases of paroxysmal idiopathic paralysis occur in older dogs, although one case of paroxysmal idiopathic paralysis was seen in a 4-year-old Shih Tzu Poodle. Paroxysmal idiopathic paralysis can be treated with the anticonvulsant carbamazepine. It can, however, be debilitating and the dog may have to be put on a full nutritional or medical support for months." - Anonymous Online Contributor

Unverified Answer

Can peripheral nervous system diseases be cured?

"In a recent study, findings suggests that it is no longer correct to advocate for a cure of peripheral neuropathies. However, the patients with the neuropathic pain or the paresthesias can be treated." - Anonymous Online Contributor

Unverified Answer

What causes peripheral nervous system diseases?

"Nerve fiber disease can be caused by injury, inflammatory processes, or a toxic insult caused by a virus, autoimmune disease, or environmental stress. Nerves are not static structures, however, and will shrink, swell, twist, change color, and die over time. Nerve fiber disorders are common and are often under-diagnosed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for peripheral nervous system diseases?

"Most therapies work only to manage a symptom and are poorly studied as treatments for a disease. Those treatments that are supported by clinical evidence typically target neuropathic pain, movement disorders, and spasticity. Clinical trials are needed for all new therapies, especially the ones based on the newest molecular knowledge, that are likely to be approved. summary: This article presents a selection of treatment options for specific patient groups, e.g., specific cancer-related health problems as well as common pain syndromes." - Anonymous Online Contributor

Unverified Answer

What are the signs of peripheral nervous system diseases?

"Data from a recent study of patients with peripheral neurological disease, the majority showed signs of autonomic (possess[ing] abnormal heart rate or blood pressure (e.g. tachycardia [fastheart rate], orthostatic hypotension [low blood pressure upon standing up]) and neurogenic deficits (e.g. abnormal reflexes and sensory functions of the extremities (e.g. absent or reduced vibration)). The peripheral neurological deficit are more severe in patients with concurrent internal disorders (e.g. depression and anxiety)." - Anonymous Online Contributor

Unverified Answer

How many people get peripheral nervous system diseases a year in the United States?

"Around 35 million people have peripheral nerve or nerve root disorders each year in the United States. Most of these cases occur before the age of 40. This makes it the most common problem in the United States among young adult Americans. Many patients who develop peripheral conditions are unaware or fail to realize the true nature of the condition before diagnosis or treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for peripheral nervous system diseases?

"The general population may include populations who would be eligible to participate in clinical trials and in whom these risks may be acceptable to them. In any case, the general population generally has a low probability of participating in clinical trials due to limited interest in the topic and a lack of willingness or willingness not to respond." - Anonymous Online Contributor

Unverified Answer

Is quality-of-life assessment typically used in combination with any other treatments?

"The quality-of-life assessment alone has an excellent likelihood of detecting moderate and substantial improvements in the patients who had undergone any treatment modality. [Power(http://www.withpower.com/d/treatments-and-side-effects/quality-of-life-assessment/quality-of-life-questionnaire/find-active-clinical-trials)()] shows the usefulness of this assessment for evaluating quality-of-life of patients with various treatments." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets peripheral nervous system diseases?

"The average age people develop PNS diseases are as follows: peripheral neuropathy (49.7 yr), amyotrophy, and Guillain-Barre syndrome and polyradiculopathy, all of which have an average first onset age of 49.7. This article will discuss clinical trials for peripheral neuropathy, amyotrophy, and Guillain-Barre syndrome. For polyradiculopathy this article discusses clinical trials." - Anonymous Online Contributor

Unverified Answer

Does peripheral nervous system diseases run in families?

"PNS diseases in families are not as common as previously thought and other neurogenic conditions should be taken into account in those patients who do not show the characteristic features of PNS diseases." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of quality-of-life assessment?

"Despite the high prevalence of depression and PNI, health-related quality of life remained unaffected by the PNI, which makes it a potentially powerful tool in the screening and early recognition of depression after serious illness." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in quality-of-life assessment for therapeutic use?

"These studies suggest that QOL is a complex and subjective concept. The measurement in the clinical setting is highly complex and results from the combination of clinical, biological, psychological, and social factors. For that reason, the measurement of QOL should always involve a balanced set of clinical, biological, psychological, and social methods. A holistic measurement may be of benefit for a variety of clinical decisions and, ultimately, for health-care providers." - 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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