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Younger women may feel more pain from chemo support drug, study suggests

NCT ID NCT04174742

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study is looking at whether younger women (45 and under) feel more pain from a drug called pegfilgrastim, which is given during chemotherapy for breast cancer, compared to older women. About 115 women will report their pain levels and have their blood counts checked. The goal is to better understand who might need extra pain management, not to change cancer treatment itself.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pegfilgrastim (or a biosimilar version)
What this could lead to
If it works, this could help doctors better manage pain from this drug in younger breast cancer patients.
What could go wrong
This is a small, observational study that only measures pain and blood counts—it won't test a new treatment or change cancer therapy directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jan 2041

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Female patients undergoing neoadjuvant or adjuvant chemotherapy for breast cancer who will receive pegfilgrastim (or biosimilar substitution) during their treatment.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Subject must meet all the following applicable inclusion criteria to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent 3. Female 4. Histological or cytological confirmation of invasive breast cancer. 5. Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis. 6. Ability to read and understand the English and/or Spanish language 7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study Exclusion Criteria Subjects meeting any of the criteria below may not participate in the study: 1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator 2. Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5 3. Taking chronic narcotics, as determined by treating physician 4. Diagnosis of distant metastatic breast cancer 5. Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.) 6. A baseline ESAS pain score of greater than 8.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST Breast cancer

Contacts and locations

Locations

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

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