# Genomic Underpinnings for Breast Cancer Treatment Induced Nausea and Vomiting

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $423,866

## Abstract

ABSTRACT/PROJECT SUMMARY
 Nausea and vomiting are frequent and debilitating symptoms experienced by women being treated for breast
cancer. These symptoms occur repeatedly due to the surgical procedure, anesthesia during surgery, opioids for
pain, adjuvant therapy, especially chemotherapy, and perhaps the disease itself. Current guidelines of the
American Society of Clinical Oncology indicate that the goal for treatment-induced nausea and vomiting should
be complete control. However, this goal has remained elusive. Results from research show that 20-30% of
women continue to experience these symptoms following surgery or chemotherapy, even when well established,
evidence based clinical guidelines are followed. Given that over 240,000 women will be diagnosed with breast
cancer in 2016, this is a highly significant problem. Treatment-induced nausea and vomiting (TINV) have a
profound impact on the health and well-being of women with breast cancer. They are related to significant
morbidity (dehydration, wound dehiscence, pain, and immobility), increased length of stay, increased hospital
costs and poor patient satisfaction.) Because the factors that influence variability in TINV and the mechanisms
underlying TINV are not clearly understood, this innovative study will employ a prospective, comparative design
to study 300 women diagnosed with early stage breast cancer (Stage I, II, IIIa) who will be recruited prior to
scheduled breast cancer surgery. We hypothesize that substantial variability in TINV occurs during the first year
of treatment following surgery for breast cancer, that this variability will cluster into distinct groups and groupings
will be explained by individual (age, race, history of nausea and vomiting), disease/treatment (medications) and
genomic factors; and co-occurring symptoms (sleep disturbance, fatigue, anxiety, pain). TINV data, using the
nausea and vomiting subscale of the Patient-Reported Outcomes Measurement Information System
Gastrointestinal (PROMISGI®), will be collected prior to initial surgery through one year of treatment. Co-
occurring symptoms will be measured using the PROMIS®29. TINV is controlled by activation of multiple cellular
receptors including those for serotonin, dopamine, histamine, acetylcholine, opioid and substance P. These
common neural mechanisms mediate TINV regardless of the etiology and will be the targets for the genomic
analysis of this study. An understanding of the precise relationship between these targets and the TINV
phenotype, and the stratification of symptoms into subgroups according to their underlying biological
mechanisms are required for the development of precision medicine strategies. In addition, a retrospective study
using banked samples linked to rich symptom phenotype data (including nausea and vomiting) in women with
breast cancer will be completed to address replication of significant genetic findings. The results of this rigorously
conducted prospective study will inform su...

## Key facts

- **NIH application ID:** 9828639
- **Project number:** 5R01NR016695-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Susan Watters Wesmiller
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $423,866
- **Award type:** 5
- **Project period:** 2018-01-22 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9828639

## Citation

> US National Institutes of Health, RePORTER application 9828639, Genomic Underpinnings for Breast Cancer Treatment Induced Nausea and Vomiting (5R01NR016695-03). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/9828639. Licensed CC0.

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