Factors associated with willingness to participate in an acupuncture clinical trial for arthralgia among breast cancer patients

6596 Background: Many breast cancer patients use complementary and alternative medicine (CAM), which warrant rigorous evaluation of the safety and efficacy of these therapies. As with conventional cancer treatment studies, researchers face challenges in accruing patients to CAM trials. This study aims to identify the factors associated with willingness to participate (WTP) in a trial evaluating use of acupuncture for arthralgia among breast cancer patients. Methods: We conducted a cross-sectional survey study among outpatient postmenopausal breast cancer patients who were receiving aromatase inhibitors. Self-reported WTP in an acupuncture trial was used as the main outcome variable. Expectation towards acupuncture efficacy was measured using a previously validated Acupuncture Expectancy Scale. Multivariate logistic regression was used to identify factors associated with WTP. Results: 300 patients participated (92% response rate), with a mean age of 61 ± 10 years, 252 (84%) White, and 38 (13%) Black. Of the participants, 148 (49.8%) reported WTP in an acupuncture trial should they be offered an opportunity for such research. In a multivariate model, higher likelihood of WTP was associated with having a college education, adjusted odds ratio (95% confidence interval), 3.78 (1.83–7.81); having previous radiation therapy 2.02 (1.13–3.62); and current experience of arthralgia 2.36 (1.11–4.98). Positive expectancy of acupuncture outcome was also associated with greater likelihood of WTP 1.20 (1.12–1.28). Age and race were not predictors of WTP in the multivariate model. Conclusions: Almost half of the outpatient breast cancer patients expressed WTP in an acupuncture clinical trial for arthralgia. Higher education, previous radiation therapy, current experience of arthralgia, and positive expectancy related to acupuncture may affect breast cancer patients’ willingness to participate in an acupuncture trial for arthralgia. No significant financial relationships to disclose.

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Factors Associated with Fatigue in Breast Cancer Patients Undergoing External Beam Radiation Therapy

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2020.02.502 ◽

2020 ◽

Vol 108 (2) ◽

pp. E16

Author(s):

Michael LaRiviere ◽

Hann-Hsiang Chao ◽

Abigail Doucette ◽

Timothy Kegelman ◽

Neil Taunk ◽

...

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Cancer Patients ◽

External Beam Radiation Therapy ◽

External Beam Radiation ◽

External Beam ◽

Breast Cancer Patients ◽

Beam Radiation ◽

Factors Associated

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Curcumin for radiation dermatitis: A randomized, double-blind, placebo-controlled clinical trial of 30 breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9027 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9027-9027

Author(s):

Julie L. Ryan ◽

Charles E Heckler ◽

Marilyn N Ling ◽

Jacqueline P Williams ◽

Alice P Pentland ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Radiation Therapy ◽

Cancer Patients ◽

Radiation Dermatitis ◽

Breast Cancer Patients ◽

Double Blind ◽

Double Blind Placebo ◽

Cancer Support ◽

Moist Desquamation

9027 Background: Radiation dermatitis occurs in approximately 95% of patients receiving radiation therapy for cancer and often leads to pain and treatment delays. There is no standard treatment with demonstrated effectiveness for the prevention of radiation dermatitis. We conducted a randomized, double-blind, placebo-control clinical trial to assess the efficacy of curcumin, a potent antioxidant and anti-inflammatory component of turmeric, to reduce radiation dermatitis in 30 breast cancer patients. Methods: Eligible patients included adult females with non-inflammatory breast cancer or carcinoma in situ prescribed radiation therapy without concurrent chemotherapy. After randomization, patients took four 500 mg capsules of curcumin or placebo three times daily throughout their course of radiation therapy (total daily dose = 6.0 g). Weekly assessments included Radiation Dermatitis Severity (RDS) Score, presence/absence of moist desquamation, erythema measure, and McGill Pain and Symptom Inventory (SI) questionnaires. Results: The 30 evaluable patients were white (90%; mean age = 58.1 years) with ER+PR+ breast cancer (76.7%) who did not have total mastectomy (90%) or chemotherapy prior to start of radiation therapy (56.7%). No significant differences were observed between arms for demographics, compliance, erythema, pain, symptoms, or radiation skin dose. Standard pooled variances t-test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs 3.4; p=0.008). Fisher’s exact test showed that curcumin significantly reduced the presence of moist desquamation at the end of radiation therapy (28.6% vs. 87.5 %; p=0.002). Repeated measures analysis confirmed divergence of RDS between curcumin and placebo arms at Week 5. Conclusions: Oral curcumin, 6.0 g daily during radiation therapy, reduced radiation dermatitis severity and moist desquamation in breast cancer patients. A multisite CCOP trial (N=700) is underway to confirm the effectiveness of curcumin to reduce radiation dermatitis severity during various radiation therapy regimens for breast cancer. Support: IND 75,444, Dermatology Foundation, KL2 RR024136, NCI PHS 1R25CA10618.

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Changes in peripheral immune cells after intraoperative radiation therapy in low-risk breast cancer

Journal of Radiation Research ◽

10.1093/jrr/rraa083 ◽

2020 ◽

Vol 62 (1) ◽

pp. 110-118

Author(s):

Isabel Linares-Galiana ◽

Miguel Angel Berenguer-Frances ◽

Rut Cañas-Cortés ◽

Monica Pujol-Canadell ◽

Silvia Comas-Antón ◽

...

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Single Dose ◽

Cancer Patients ◽

Antitumor Immunity ◽

Low Risk ◽

Intraoperative Radiation Therapy ◽

Breast Cancer Patients ◽

Intraoperative Radiation ◽

Risk Breast Cancer

Abstract A detailed understanding of the interactions and the best dose-fractionation scheme of radiation to maximize antitumor immunity have not been fully established. In this study, the effect on the host immune system of a single dose of 20 Gy through intraoperative radiation therapy (IORT) on the surgical bed in low-risk breast cancer patients undergoing conserving breast cancer has been assessed. Peripheral blood samples from 13 patients were collected preoperatively and at 48 h and 3 and 10 weeks after the administration of radiation. We performed a flow cytometry analysis for lymphocyte subpopulations, natural killer cells (NK), regulatory T cells (Treg) and myeloid-derived suppressor cells (MDSCs). We observed that the subpopulation of NK CD56+high CD16+ increased significantly at 3 weeks after IORT (0.30–0.42%, P < 0.001), while no changes were found in immunosuppressive profile, CD4+CD25+Foxp3+Helios+ Treg cells, granulocytic MDSCs (G-MDSCs) and monocytic MDSCs (Mo-MDSCs). A single dose of IORT may be an effective approach to improve antitumor immunity based on the increase in NK cells and the non-stimulation of immunosuppressive cells involved in immune escape. These findings support future combinations of IORT with immunotherapy, if they are confirmed in a large cohort of breast cancer patients.

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Is there a worthwhile value in personalizing radiation therapy for breast cancer patients? Time for a new paradigm in the older adult population

Expert Review of Precision Medicine and Drug Development ◽

10.1080/23808993.2021.1897463 ◽

2021 ◽

pp. 1-4

Author(s):

Viola Salvestrini ◽

Matteo Mariotti ◽

Marco Banini ◽

Carlotta Becherini ◽

Luca Visani ◽

...

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Cancer Patients ◽

Older Adult ◽

Adult Population ◽

Breast Cancer Patients ◽

New Paradigm ◽

Older Adult Population

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Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽

10.1186/s12885-021-08197-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Safa Najafi ◽

Maryam Ansari ◽

Vahid Kaveh ◽

Shahpar Haghighat

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Single Dose ◽

Side Effects ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Injection Site Reaction ◽

Study Groups ◽

Breast Cancer Patients ◽

Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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An Exploration of Heart Failure Risk in Breast Cancer Patients Receiving Anthracyclines with or without Trastuzumab in Thailand: A Retrospective Study

Clinics and Practice ◽

10.3390/clinpract11030064 ◽

2021 ◽

Vol 11 (3) ◽

pp. 484-493

Author(s):

Jukapun Yoodee ◽

Aumkhae Sookprasert ◽

Phitjira Sanguanboonyaphong ◽

Suthan Chanthawong ◽

Manit Seateaw ◽

...

Keyword(s):

Breast Cancer ◽

Risk Factors ◽

Cancer Patients ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Breast Cancer Patients ◽

Ventricular Ejection Fraction ◽

Factors Associated ◽

Palliative Intent ◽

Increased Risk

Anthracycline-based regimens with or without anti-human epidermal growth factor receptor (HER) 2 agents such as trastuzumab are effective in breast cancer treatment. Nevertheless, heart failure (HF) has become a significant side effect of these regimens. This study aimed to investigate the incidence and factors associated with HF in breast cancer patients treated with anthracyclines with or without trastuzumab. A retrospective cohort study was performed in patients with breast cancer who were treated with anthracyclines with or without trastuzumab between 1 January 2014 and 31 December 2018. The primary outcome was the incidence of HF. The secondary outcome was the risk factors associated with HF by using the univariable and multivariable cox-proportional hazard model. A total of 475 breast cancer patients were enrolled with a median follow-up time of 2.88 years (interquartile range (IQR), 1.59–3.93). The incidence of HF was 3.2%, corresponding to an incidence rate of 11.1 per 1000 person-years. The increased risk of HF was seen in patients receiving a combination of anthracycline and trastuzumab therapy, patients treated with radiotherapy or palliative-intent chemotherapy, and baseline left ventricular ejection fraction <65%, respectively. There were no statistically significant differences in other risk factors for HF, such as age, cardiovascular comorbidities, and cumulative doxorubicin dose. In conclusion, the incidence of HF was consistently high in patients receiving combination anthracyclines trastuzumab regimens. A reduced baseline left ventricular ejection fraction, radiotherapy, and palliative-intent chemotherapy were associated with an increased risk of HF. Intensive cardiac monitoring in breast cancer patients with an increased risk of HF should be advised to prevent undesired cardiac outcomes.

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