Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study (A-NEW)

A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer

This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Overweight or Obesity
• Intervention / Treatment: Drug: Contrave; Behavioral: Behavioral Weight Loss

Detailed Description

The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jennifer Sheng, MD; Phone Number: 410-614-0762; Email: jsheng7@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy
• Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
• Up to date with recommended screening mammography within one year
• Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication
• Able to read and write the English language without assistance and daily access to the e-mail and/or smartphone
• Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

• Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
• Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
• Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
• Diabetes on insulin or sulfonylureas within the past 3 months
• Unstable psychiatric disorder or bulimia/anorexia nervosa
• Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug

• Use of the following medications are excluded:

  • Monoamine oxidase (MAO) inhibitors (must be >14 days from discontinuation)
  • Thyroid medication use unless on stable doses for at least the past 3 months
  • Buproprion containing products or opiate agonists (must be >14 days from discontinuation)
  • Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months
  • Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that SSRI's and SNRI's are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake inhibitor (SNRI) use is required).
  • Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins) unless on stable doses ≥3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs are allowed if use is limited to <3 times per week; chronic NSAIDs are permitted on study only if use has been ≥3 times per week for at least 3 months prior to registration and is expected to continue.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLOW-BWL; All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6.	Drug: Contrave; Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.; Other Names: Naltrexone/Bupropion; Behavioral: Behavioral Weight Loss; 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.
Active Comparator: FAST-BWL; All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL)	Behavioral: Behavioral Weight Loss; 6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with 5 percent weight loss (in SLOW-BWL)	To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in HbA1c levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare HbA1c (%) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in HbA1c levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare HbA1c (%) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in IGF1 levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare Insulin-like growth factor 1 (IGF1) (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in IGF1 levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	Baseline, 2 months and 6 Months
Change in IGF1 levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare IGF1 (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Fasting glucose levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting glucose levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting glucose levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare fasting glucose (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Fasting lipids levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting lipids levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting lipids levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare fasting lipids (mg/dL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	6 Months
Change in Fasting insulin levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting insulin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Fasting insulin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare fasting insulin (mIU/L) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss	To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Adiponectin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Adiponectin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare adiponectin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Leptin levels among SLOW-BWL participants who achieve ≥5% weight loss	To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Leptin levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Leptin levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare leptin (ng/mL) levels at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	Baseline, 2 months and 6 Months
Change in Microbiome composition among SLOW-BWL participants who achieve ≥5% weight loss	To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Microbiome composition among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Microbiome composition among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare microbiome composition (ratio of bacteroides and firmacutes) at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Godin Leisure-Time Exercise questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Godin Leisure-Time Exercise questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Godin (score range start from 0 with no upper limit but higher scores indicate more exercise) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Pittsburgh Sleep Quality Index (PSQI) questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare PSQI (scores range 0-21 with higher scores indicating poorer sleep) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Physical Function - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Physical Function - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Physical Function - Short Form (scores range 10-50 with higher scores indicating better physical functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Pain Interference - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Pain Interference - Short Form (scores range 6-30 with lower scores indicating less pain interference) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Fatigue - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Fatigue - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Fatigue - Short Form (scores range 7-35 with higher scores indicating more fatigue) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Depression - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Depression - Short Form (scores range 8-40 with lower scores indicating lower levels of depression) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on PROMIS Emotional Distress - Anxiety - Short Form questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Anxiety - Short Form (scores range 7-35 with lower scores indicating lower levels of anxiety) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on Sexual Function questionnaire among SLOW-BWL participants who achieve ≥5% weight loss	To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Sexual Function questionnaire among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Sexual Function questionnaire among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare Sexual Function (scores range 4-20 with lower scores indicating better sexual functioning) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in NCI quick food scan comparison among SLOW-BWL participants who achieve ≥5% weight loss	To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in NCI quick food scan comparison among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare NCI quick food scan scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in NCI quick food scan comparison among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare NCI quick food scan scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL participants who achieve ≥5% weight loss	To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL who achieve ≥5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss	To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among SLOW-BWL women who achieve ≥5% weight loss versus the SLOW-BWL women who do not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to	To compare FACT-ES (scores range 0-76 with higher scores indicating poorer functional assessment) scores at 2 and 6 months to baseline levels among FAST-BWL vs SLOW-BWL, as well as participants who achieve ≥5% weight loss at 6 months vs those who are unable to.	Baseline, 2 months and 6 Months
Change in Minutes of Moderate to Vigorous Physical Activity (MVPA)	To compare minutes of MVPA reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.	Baseline, 2 months and 6 Months
Change in Number of daily steps	To compare the number of daily steps reported in Fitbit at 2 and 6 months to baseline levels among SLOW-BWL who achieved ≥5% weight loss vs the SLOW-BWL who did not achieve 5% weight loss.	Baseline, 2 months and 6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with 5% weight loss (in FAST-BWL)	To assess the proportion of women in the FAST-BWL arm who maintain ≥5% weight loss at 6 months.	6 months
Number of participants with AA genotype and 5% weight loss	To assess prevalence of AA genotype of MnSOD in breast cancer survivors with excess weight and if a greater proportion of women with the AA genotype achieve ≥5% weight loss and improvement in biomarkers at 6 months compared to the women who do not.	6 months
Number of participants with AA genotype and Contrave	To determine if women who display the AA genotype of MnSOD and undergo addition of Contrave to BWL have greater weight loss compared to women who do not receive Contrave.	6 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Breast Cancer Research Foundation; American Institute for Cancer Research; Hopkins-WellSpan Cancer Research Fund
• Investigators: Principal Investigator: Jennifer Sheng, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): January 10, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss; Overweight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Anti-Obesity Agents; Alcohol Deterrents; Dopamine Uptake Inhibitors; Naltrexone; Bupropion; Bupropion hydrochloride, naltrexone hydrochoride drug combination
• Other Study ID Numbers: IRB00223131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes