Clinical trial NCT03169023: Scale Down for Endometrial Cancer
Official title: Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Cancer of the Endometrium
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: ScaleDown
First posted: 2017-05-30
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.


Eligibility criteria: Inclusion Criteria:

* Female women 18 years of age or older and with biopsy-proven endometrial cancer.
* BMI greater than or equal to 30 kg/m\^2.
* Must be able to read and speak English.
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.
* Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting Aim 1.
* Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of enrollment AND, if randomized, is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention
* Patients with BMI greater than or equal to 30 kg/m\^2 who are undergoing hormonal treatment of endometrial cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy of at least one year
* Must have a phone capable of receiving text messages.

Exclusion Criteria:

* Females under the age of 18 years
* BMI less than 30 kg/m\^2
* Must not be participating in another formal weight loss program.
* Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent.
* For participants who are randomized in Aim 1:

  * No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a previously completed Patient Health Questionnaire (PHQ-9) score \>9 (Kroenke)
  * No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 2 years.

Primary outcomes:
measure: Mean weight loss compared between the two arms
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Andrea Hagemann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zamorano AS, Wilson EM, Liu J, Leon A, Kuroki LM, Thaker PH, McCourt CK, Fuh KC, Powell MA, Mutch DG, Evanoff BA, Colditz GA, Hagemann AR. Text-message-based behavioral weight loss for endometrial cancer survivors with obesity: A randomized controlled trial. Gynecol Oncol. 2021 Sep;162(3):770-777. doi: 10.1016/j.ygyno.2021.06.007. Epub 2021 Jun 14.