Bupropion for Control of Hot Flashes in Breast Cancer Survivors: A Prospective, Double-Blind, Randomized, Crossover, Pilot Phase II Trial

PURPOSE: Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis. PATIENTS AND METHODS: This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects. RESULTS: Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks. There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed. CONCLUSION: The soy product did not alleviate hot flashes in breast cancer survivors.

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A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors

Psycho-Oncology ◽

10.1002/pon.4849 ◽

2018 ◽

Vol 27 (10) ◽

pp. 2450-2457 ◽

Cited By ~ 2

Author(s):

Rachel Hirschey ◽

Gretchen Kimmick ◽

Marilyn Hockenberry ◽

Ryan Shaw ◽

Wei Pan ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Phase Ii ◽

Breast Cancer Survivors ◽

Phase Ii Trial ◽

Outcome Expectations ◽

Randomized Phase Ii

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A pilot phase II trial of magnesium supplements to reduce menopausal hot flashes in breast cancer patients

Supportive Care in Cancer ◽

10.1007/s00520-011-1099-7 ◽

2011 ◽

Vol 19 (6) ◽

pp. 859-863 ◽

Cited By ~ 16

Author(s):

Haeseong Park ◽

Gwendolyn L. Parker ◽

Cecelia H. Boardman ◽

Monica M. Morris ◽

Thomas J. Smith

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Phase Ii ◽

Phase Ii Trial ◽

Hot Flashes ◽

Breast Cancer Patients ◽

Pilot Phase

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Randomized Phase II Trial of Exercise, Metformin, or Both on Metabolic Biomarkers in Colorectal and Breast Cancer Survivors

JNCI Cancer Spectrum ◽

10.1093/jncics/pkz096 ◽

2019 ◽

Vol 4 (1) ◽

Cited By ~ 3

Author(s):

Jeffrey A Meyerhardt ◽

Melinda L Irwin ◽

Lee W Jones ◽

Sui Zhang ◽

Nancy Campbell ◽

...

Keyword(s):

Breast Cancer ◽

Growth Factor ◽

Cancer Survivors ◽

Phase Ii ◽

Breast Cancer Survivors ◽

Phase Ii Trial ◽

Model Assessment ◽

Insulin Like Growth Factor ◽

Fasting Insulin ◽

Insulin Levels

Abstract Background Observational data support inverse relationships between exercise or metformin use and disease outcomes in colorectal and breast cancer survivors, although the mechanisms underlying these associations are not well understood. Methods In a phase II trial, stage I–III colorectal and breast cancer survivors who completed standard therapy were randomly assigned to structured exercise or metformin or both or neither for 12 weeks. The primary outcome was change in fasting insulin levels; secondary outcomes included changes in other blood-based energetic biomarkers and anthropometric measurements. Analyses used linear mixed models. Results In total, 139 patients were randomly assigned; 91 (65%) completed follow-up assessments. Fasting insulin levels statistically significantly decreased in all three intervention arms (−2.47 μU/mL combination arm, −0.08 μU/mL exercise only, −1.16 μU/mL metformin only, + 2.79 μU/mL control arm). Compared with the control arm, all groups experienced statistically significant weight loss between baseline and 12 weeks (−1.8% combination arm, −0.22% exercise only, −1.0% metformin only, +1.55% control). The combination arm also experienced statistically significant improvements in the homeostatic model assessment for insulin resistance (−30.6% combination arm, +61.2% control) and leptin (−42.2% combination arm, −0.8% control), compared with the control arm. The interventions did not change insulin-like growth factor–1 or insulin-like growth factor binding protein–3 measurements as compared with the control arm. Tolerance to metformin limited compliance (approximately 50% of the participants took at least 75% of the planned dosages in both treatment arms). Conclusions The combination of exercise and metformin statistically significantly improved insulin and associated metabolic markers, as compared to the control arm, with potential greater effect than either exercise or metformin alone though power limited formal synergy testing. Larger efforts are warranted to determine if such a combined modality intervention can improve outcomes in colorectal and breast cancer survivors.

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Use of Guarana for Hot Flashes after Breast Cancer: Randomized, Double-Blind, Placebo-Controlled Phase II Trial

Journal of Natural Remedies ◽

10.18311/jnr/2019/22737 ◽

2019 ◽

Vol 19 (1) ◽

pp. 1-11 ◽

Cited By ~ 1

Author(s):

Abna Faustina de Sousa Vieira ◽

Vitor Augusto Queiroz Mauad ◽

Daniel Cubero ◽

Patr�cia Xavier Santi ◽

Auro del Giglio ◽

...

Keyword(s):

Breast Cancer ◽

Phase Ii ◽

Phase Ii Trial ◽

Hot Flashes ◽

Double Blind ◽

Double Blind Placebo

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10 / OMEGA-3 (Ω3) SUPPLEMENTATION VERSUS OMEGA-6 (Ω6) SUPPLEMENTATION FOR PAIN AMONG BREAST CANCER SURVIVORS: A URCC NCORP PHASE II FEASIBILITY RCT

10.26226/morressier.5afadd8af314ac000849b344 ◽

2018 ◽

Author(s):

Luke Peppone

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Phase Ii ◽

Breast Cancer Survivors ◽

Omega 3 ◽

Omega 6 ◽

Feasibility Rct

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Perilla Oil and Bifidobacterium for Alleviating Fear of Cancer Recurrence in Breast Cancer Survivors: Study Protocol for a Three-Arm Phase II Randomized Controlled Study (POB Study)

Methods and Protocols ◽

10.3390/mps4030046 ◽

2021 ◽

Vol 4 (3) ◽

pp. 46

Author(s):

Yohei Sasaki ◽

Mina Honyashiki ◽

Takayuki Kinoshita ◽

Akira Matsui ◽

Ayako Nakashoji ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Phase Ii ◽

Study Protocol ◽

Breast Cancer Survivors ◽

Cancer Recurrence ◽

Fear Of Cancer Recurrence ◽

Randomized Controlled ◽

Perilla Oil ◽

Fear Of Cancer

The fear of cancer recurrence (FCR) is the most common and most severe unmet need among cancer survivors. Safe treatments for the FCR that are easily disseminated are greatly needed. Our primary aim is a preliminary evaluation of the efficacy and effect size of perilla oil, which is rich in omega-3 fatty acids, and Bifidobacterium, a probiotic, on FCR in breast cancer survivors after the completion of chemotherapy. This study has been planned as an exploratory clinical study (phase II) and will be conducted as a three-arm, 12-week parallel group, masked-rater randomized controlled trial. Fifteen participants will be randomized with 1:1:1 allocation to receive Bifidobacterium plus perilla oil, Bifidobacterium alone, or no intervention (control). Interventions will end within 12 weeks after the random allocation of each participant. The participants will be outpatients with invasive breast cancer aged 20 years or older whose chemotherapy was completed at least 6 months before registration; hormone therapy may be ongoing. The primary outcome will be severity of FCR at 12 weeks assessed by masked raters using the 4-item Concerns about Recurrence Scale concerning overall fear of recurrence. The study protocol for the current study is registered in the Japan Registry of Clinical Trials (jRCTs031200029).

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A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378)

European Journal of Cancer ◽

10.1016/j.ejca.2015.10.012 ◽

2016 ◽

Vol 53 ◽

pp. 144-154 ◽

Cited By ~ 19

Author(s):

Konstantinos Tryfonidis ◽

Gul Basaran ◽

Jan Bogaerts ◽

Marc Debled ◽

Luc Dirix ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Phase Ii ◽

Hormone Receptor ◽

Phase Ii Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Multicentre Phase ◽

European Organisation ◽

Hormone Receptor Positive

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Phase II Trial of Anastrozole Plus Goserelin in the Treatment of Hormone Receptor–Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Journal of Clinical Oncology ◽

10.1200/jco.2009.24.9565 ◽

2010 ◽

Vol 28 (25) ◽

pp. 3917-3921 ◽

Cited By ~ 59

Author(s):

Robert. W. Carlson ◽

Richard Theriault ◽

Christine M. Schurman ◽

Edgardo Rivera ◽

Cathie T. Chung ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Antitumor Activity ◽

Phase Ii ◽

Hormone Receptor ◽

Phase Ii Trial ◽

Hot Flashes ◽

Metastatic Breast ◽

Premenopausal Women ◽

Hormone Receptor Positive

Purpose To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor–positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin. Patients and Methods Premenopausal women with estrogen and/or progesterone receptor–positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity. Results Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities. Conclusion The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor–positive metastatic breast cancer.

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