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Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.

ABSTRACT: Introduction:The objective of this pilot randomized controlled trial was to investigate the combined effect of a Mediterranean diet and naltrexone/bupropion treatment on body weight, metabolic parameters, and quality of life in overweight or obese breast cancer survivors. Methods:Forty-four breast cancer survivors were randomly assigned to receive the Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (breast cancer survivor MeDiet-only group). Twenty-eight age-matched non-cancer patients were instructed to consume the Mediterranean diet plus naltrexone/bupropion medication (non-cancer MeDiet+NB group). After the 8-week intervention, changes in body weight, metabolic parameters, nutrient intake, and quality of life of the three groups were assessed. Results:Significant weight loss of 2.8 kg was noted for the breast cancer survivor MeDiet+NB group, 1.8 kg for the breast cancer survivor MeDiet-only group, and 2.5 kg for the non-cancer MeDiet+NB group after 8 weeks (P < 0.05 versus baseline by Wilcoxon's signed-rank test). All three groups also exhibited significantly lower fasting glucose, insulin, and homeostasis model assessment of insulin resistance levels (P < 0.05). Quality of life as assessed by self-reported questionnaires showed improvement in all participants (P < 0.05). However, there were no significant differences of changes in body weights, metabolic parameters, and quality of life among the three groups or between the MeDiet+NB and MeDiet-only groups. Conclusion:We found that the Mediterranean diet, with or without naltrexone/bupropion treatment, facilitates weight loss, improves metabolic parameters, and increases quality of life. The combination of the Mediterranean diet with naltrexone/bupropion treatment did not produce superior changes when compared to the Mediterranean diet alone. Trial Registration:This trial was retrospectively registered on 10 July 2018 as NCT03581630 at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03581630).

SUBMITTER: Cho AR

PROVIDER: S-EPMC7532917 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.

Cho A-Ra AR Choi Won-Jun WJ Kwon Yu-Jin YJ Lee Hye Sun HS Ahn Sung Gwe SG Lee Ji-Won JW

Diabetes, metabolic syndrome and obesity : targets and therapy 20200929

<h4>Introduction</h4>The objective of this pilot randomized controlled trial was to investigate the combined effect of a Mediterranean diet and naltrexone/bupropion treatment on body weight, metabolic parameters, and quality of life in overweight or obese breast cancer survivors.<h4>Methods</h4>Forty-four breast cancer survivors were randomly assigned to receive the Mediterranean diet plus naltrexone/bupropion medication (breast cancer survivor MeDiet+NB group) or the Mediterranean diet alone (b ...[more]

PMID: 33061494

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Project description:BackgroundMost women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the baseline body weight) in a group of overweight or obese breast cancer survivors.Methods/designThis is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants' dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants' quality of life and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group.DiscussionWhile there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors.Trial registrationISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015).

Project description:Aims and objectivesTo determine whether a weight management intervention (WMI) plus cardiac rehabilitation (CR) compared to CR alone improves outcomes for overweight and obese cardiac revascularisation patients.BackgroundDespite participating in cardiac rehabilitation (CR), few cardiac patients lose enough weight to achieve clinically significant cardiovascular disease risk reduction.DesignA randomised controlled design was used with measurements at baseline, 4 and 6 months, guided by the CONSORT checklist, see Supporting Information File S1. Adults who had undergone either coronary artery bypass surgery (CABS) or percutaneous coronary intervention (PCI) and participated in a rural CR programmes were recruited. Subjects were randomised to a 12-week telehealth WMI or control group. The primary outcome was weight loss. Secondary outcomes included physical activity, patient activation, perceived self-efficacy and use of weight management behaviours.ResultsA total of 43 subjects participated, with a mean age of 63 (±9.3) years. The WMI group had significantly more weight loss averaged across the 4 and 6 months of 13.8 (±2.8) pounds compared to the control group [mean = 7.8 (±2.2) pounds]. There were no significant differences in physical activity (activity counts or daily minutes in moderate or more intense activity). The WMI group had significantly higher levels of patient activation. They also had significantly higher total scores on the Diet and Exercise Self-Management survey, and subscales that included self-efficacy for specific eating habits and managing diet behaviour.ConclusionsFindings demonstrated the usefulness and feasibility of using telehealth delivery of the WMI for cardiac rehabilitation participants in rural communities to improve weight management outcomes.Relevance to practiceStudy findings underscore the opportunity to further improve weight loss of overweight and obese cardiac participants using a weight management intervention to augment CR participation.

Dataset Information

Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.

Publications

Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial.

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