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Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT03042897
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.

Condition or disease Intervention/treatment Phase
Estrogen Receptor Positive Obesity Progesterone Receptor Positive Stage I Uterine Corpus Cancer Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Dietary Supplement: Dietary Intervention Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.

SECONDARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.

TERTIARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.

II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.

OUTLINE:

Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.

After completion of study, patients are followed up for 16 weeks.

After completion of study, patients are followed up for 16 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : September 8, 2020
Estimated Study Completion Date : September 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (exercise and diet)
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
Dietary Supplement: Dietary Intervention
Undergo DASH diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Behavioral: Exercise Intervention
Undergo in aerobic exercise

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Cardiorespiratory Fitness (CRF) [ Time Frame: Up to 34 weeks ]
    Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.

  2. Cardiovascular (CV) health outcomes [ Time Frame: Up to 34 weeks ]
    Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.

  3. Depression measured by Center for Epidemiologic Studies Depression scale [ Time Frame: Up to 34 weeks ]
    Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).

  4. Fatigue measured by the Brief Fatigue Inventory [ Time Frame: Up to 34 weeks ]
    Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).

  5. Muscle strength [ Time Frame: Up to 34 weeks ]
    The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.

  6. Percent weight loss at the completion of the intervention [ Time Frame: At 16 weeks ]
    Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.

  7. Quality of Life (QOL) [ Time Frame: Up to 34 weeks ]
    The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical stage I EC
  • Low grade disease positive for estrogen and progesterone receptors
  • Body mass index (BMI) >= 30 kg/m^2
  • No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
  • Self ambulatory and without use of assistive walking devices
  • Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
  • Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)

    • Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study

Exclusion Criteria:

  • Patients with metastatic disease
  • BMI =< 29.9 kg/m^2
  • History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
  • Is not self ambulatory and relies on the use of assistive walking devices
  • Is a candidate for immediate hysterectomy, following evaluation by a physician
  • In judgement of a physician, is not a candidate for progestin agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042897


Contacts
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Contact: Christina Dieli-Conwright, PhD 323-442-2180 cdieli@usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Christina Dieli-Conwright, PhD    323-442-2905    cdieli@usc.edu   
Principal Investigator: Christina Dieli-Conwright, PhD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina Dieli-Conwright, PhD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03042897     History of Changes
Other Study ID Numbers: 5U-16-1
NCI-2016-01684 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
5U-16-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Nutrition Disorders
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Endometrial Neoplasms
Uterine Neoplasms
Weight Loss
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Urogenital Neoplasms
Neoplasms by Site
Neoplasms