Endometrial Cancer Clinical Trial
Official title:
Transdisciplinary Research on Energetics (TREC) and Cancer Cross Center Study / Obesity and Weight Loss in Endometrial Cancer Survivors: A Randomized, Multi-site Trial (Lifestyle Beyond Cancer Study)
This randomized, controlled study evaluates the efficacy of weigh loss interventions in endometrial cancer survivors, using novel technology-based weight loss platforms. This is a multi-site, pilot feasibility study which will provide preliminary data to support a larger NIH funded, mult-center trial.
Status | Completed |
Enrollment | 207 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Aim 2 1. Women 18 years of age or older and with biopsy-proven endometrial cancer, 2. Body Mass Index (BMI) greater than or equal to 30 kg/m2 (based on most recent routine clinical measurement recorded in patient's medical record), 3. Must be able to read and speak English fluently, and 4. All patients must be informed of the investigational nature of the Aim 2 survey study and must give written informed consent for Aim 2 study activities in accordance with institutional and federal guidelines. (Aim 2 consent is obtained and documented as described on page 1 of the Endometrial Cancer Questionnaire). Aim 1 1. Woman who was recruited to and completed Aim 2 of the study, 2. Has completed prior surgical or other medical management and adjuvant endometrial cancer treatment, prior to starting Aim 1, 3. Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of randomization AND, after randomization, it 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, 4. No evidence of active endometrial cancer disease as determined by physician evaluation prior to randomization, 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 6. Life expectancy of at least one year, 7. Must have access to either wireless Internet, or a smart phone such as an Android or Apple iPhone, and 8. 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. Exclusion Criteria: Aim 2 1. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 2 protocol compliance or a participant's ability to give informed consent. 4.3.2.2 Aim 1 2. Must not be participating in another weight loss program or taking weight loss medications, 3. 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 Patient Health Questionnaire (PHQ-9) score >19, or a score of =1 on the suicidal ideation item (#9 on the PHQ-9) 4. 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 5 years. Carcinosarcoma is not excluded as the investigators are including women with Type I and II endometrial cancer. For the purposes of the trial, carcinosarcoma falls into the Type II category. 5. No diagnoses of autoimmune disorders (including lupus, rheumatoid arthritis, Siogren's syndrome, Crohn's disease and ulcerative colitis), immune-compromised disorders (i.e., HIV/AIDS), 6. Not receiving at time of randomization, and not expected to receive at any time during the Aim 1 intervention, any medications that may affect the inflammatory markers of interest (i.e., steroids, immunosuppressants or transplant medications), and 7. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 1 protocol compliance or a participant's ability to give informed consent. 8. Must not be pregnant. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Washington University in St Louis (Siteman Cancer Center) | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | Dana-Farber Cancer Institute, National Cancer Institute (NCI), University of Pennsylvania, Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Weight (kilograms) | Change in weight (in kilograms) of study participants randomized to one of three weight loss intervention programs will be assessed. Measurement of this change will be evaluated from weights taken at baseline (randomization) and six months, the conclusion of the intervention program. | Change from Baseline Weight at 6 months | No |
Primary | Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL | Change in IGFBP-1 (in ng/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IGFBP-1 at 6 months | Yes |
Primary | Serum biomarker: Change in levels of Adiponectin, in ug/mL | Change in Adiponectin (in ug/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline Adiponectin at 6 months | Yes |
Primary | Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL | Change in VEGF (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline VEGF at 6 months | Yes |
Primary | Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL | Change in IL1-beta (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IL1-beta at 6 months | Yes |
Primary | Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL | Change in IL2 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IL2 at 6 months | Yes |
Primary | Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL | Change in IL6 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IL6 at 6 months | Yes |
Primary | Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL | Change in IL7 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IL7 at 6 months | Yes |
Primary | Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL | Change in IL8 (in pg/mL) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline IL8 at 6 months | Yes |
Primary | Serum biomarker: Change in C reactive protein (CRP), in mg/L | Change in CRP (in mg/L) of randomized study participants will be assessed in peripheral blood samples collected at baseline (randomization) and again at 6 months, the conclusion of the intervention program. | Change from Baseline CRP at 6 months | Yes |
Secondary | Knowledge of the association between obesity and endometrial cancer risk | Participants' level of knowledge of the association between obesity and the risk of endometrial cancer will be assessed at baseline. Frequencies of categorical responses will be reported. The instrument used to collect this data is a participant completed Endometrial Cancer Questionnaire and was developed by the study investigators. | Baseline | No |
Secondary | Psychosocial measure: Change in Body Image | Change in participants' self-reported body image will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Two validated, participant-completed instruments will be utilized to assess this outcome: the Multidimensional Body Self Relations Questionnaire-Appearance Subscales (MBSRQ-AS) and the Cancer-Related Body Image Scale (CRBI). | Change from Baseline Body Image at 6 months | No |
Secondary | Psychosocial measure: Change in Quality of Life | Change in participants' self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the 12-Item Short Form Health Survey (SF-12). | Change from Baseline in Quality of Life at 6 months | No |
Secondary | Psychosocial measure: Change in Mood | Change in participants' self-reported quality of life will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the Patient Health Questionnaire 9-Item Version (PHQ-9). | Change from Baseline in Mood at 6 months | No |
Secondary | Psychosocial measure: Change in Sexual Functioning | Change in participants' self-reported sexual functioning will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. Three validated, participant-completed instruments will be utilized to assess this outcome: the Female Sexual Function Index (FSFI), the Dyadic Adjustment Scale (DAS), and the Female Sexual Distress Scale-Revised (FSDS-R). | Change from Baseline in Sexual Functioning at 6 months | No |
Secondary | Psychosocial measure: Change in Physical Activity | Change in participants' self-reported physical activity will be assessed at baseline (randomization) and again at 6 months, the conclusion of the intervention program. One validated, participant-completed instrument will be utilized to assess this outcome: the International Physical Activity Questionnaire Short Form (IPAQ). | Change from Baseline Physical Activity at 6 months | No |
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