Clinical Trial 16914

Cancer Type:

Study Type: Other
Phase of Study: Pilot

  • Heather Jim


Study Title

Sickness Behaviors in Gynecologic Cancer Patients Treated with Chemotherapy


This research is being done to find out if there is a link between side effects of chemotherapy and inflammation. To do this, we are going to be measuring several markers of inflammation in the blood, such as soluble interleukin 1 receptor antagonist (sIL-1ra), interleukin-6 (IL-6), creactive protein (CRP), and soluble receptor tumor necrosis factor II (sTNFR-II). In order to study the role of inflammation in side effects of chemotherapy for gynecologic cancer, we need to collect and compare information from patients who receive chemotherapy as well as from people who have no history of cancer.


Aim 1: To identify the magnitude and features of changes in sickness behaviors (i.e., fatigue,depression, and disruptions in sleep and activity) and pro-inflammatory cytokines in gynecologic cancer patients treated with chemotherapy compared to women without cancer. The cancer sample is expected to demonstrate greater increases in sickness behaviors and pro-inflammatory cytokines during chemotherapy than the non-cancer sample. Comparisons will also provide information on whether sickness behaviors and pro-inflammatory cytokines in the cancer sample are elevated prior to chemotherapy and whether they increase, decrease, or remain stable following completion of chemotherapy. Sickness behaviors in patients are expected to increase in a cascade pattern, with sleep disruptions predicting lagged increases in fatigue and fatigue predicting lagged increases in depression. Aim 2: To examine changes in pro-inflammatory cytokines as a mechanism of changes in sickness behaviors related to receipt of platinum- and taxane-based chemotherapy. It is expected that pro - inflammatory cytokines will be positively correlated with sickness behaviors over time. It is also expected that pro-inflammatory cytokines will mediate the relationship between patient/non-patient status and sickness behaviors over time. Aim 3: To examine the effects of experimental induction of relaxed mood on pro-inflammatory cytokine levels and sickness behaviors in women treated for gynecologic cancer who report clinically significant fatigue or depression. It is expected that decreases in pro-inflammatory cytokines, fatigue, and depression will be seen shortly after induction of relaxed mood but not neutral mood.

Inclusion Criteria

> Inclusion Criteria for All Participants:

  • greater than 18 years of age
  • have no documented or observable psychiatric or neurological disorders that would interfere with study participation
  • have no reported or documented diagnosis of immune-related disease
  • must not be pregnant
  • must not smoke
  • able to speak and read English
  • able to provide informed consent
  • Inclusion Criteria for Patient Participants:
  • Potential patient participants will be identified by their medical oncologist at Moffitt Cancer Center (MCC).
  • must be diagnosed with gynecologic cancer (i.e., ovarian, endometrial, peritoneal, fallopian, uterine, cervical, or vaginal)
  • have not previously undergone chemotherapy or radiation in the six months prior to recruitment for the current study
  • must be scheduled to undergo intravenous first- or second-line platinum- and taxane-based chemotherapy at MCC
  • live within 50 miles of MCC
  • Inclusion Criteria for Non-Patient Participants:
  • Recruitment of non-patient participants will occur in tandem with recruitment of patient participants.
  • have not been diagnosed with any form of cancer (except non-melanoma skin cancer)
  • must be within five years of the age of the patient participant to whom they are being matched
  • have a mailing address and a working telephone number
  • reside within the same zip code as the patient participant to whom they are being matched.