Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial

2011 ◽  
Vol 29 (21) ◽  
pp. 2845-2851 ◽  
Author(s):  
Rajendra Badwe ◽  
Rohini Hawaldar ◽  
Vani Parmar ◽  
Mandar Nadkarni ◽  
Tanuja Shet ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Single Injection ◽  
Controlled Trial ◽  
Group Versus ◽  
Operable Breast Cancer ◽  
Control Group ◽  
Node Positive ◽  
Randomized Controlled

Purpose Many nonrandomized studies have suggested better outcome for patients with breast cancer who undergo surgery during the luteal (progestogenic) phase of their menstrual cycle, but this is controversial. We investigated the effect of a single preoperative injection of hydroxyprogesterone in women with operable breast cancer (OBC) in a randomized controlled trial (ClinicalTrials.gov identifier, NCT00123669). Patients and Methods One thousand patients with OBC were randomly assigned to receive surgery or an intramuscular injection of depot hydroxyprogesterone 500 mg 5 to 14 days before surgery. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), respectively. An analysis by axillary lymph node status was preplanned. Results At a median follow-up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In the progesterone group versus control group, 5-year DFS and OS rates were 73.9% v 70.2% (hazard ratio [HR], 0.87; 95% CI, 0.68 to 1.09; P = .23) and 80.2% v 78.4% (HR, 0.92; 95% CI, 0.69 to 1.21; P = .53), respectively. In 471 node-positive patients, the 5-year DFS and OS rates in the progesterone group versus control group were 65.3% v 54.7% (HR, 0.72; 95% CI, 0.54 to 0.97; P = .02) and 75.7% v 66.8% (HR, 0.70; 95% CI, 0.49 to 0.99; P = .04), respectively. In multivariate analysis, DFS was significantly improved with progesterone in node-positive patients (adjusted HR, 0.71; 95% CI, 0.53 to 0.95; P = .02), whereas there was no significant effect in node-negative patients (P for interaction = .04). Conclusion A single injection of hydroxyprogesterone before surgery did not improve outcomes in all women with OBC. This intervention showed significant improvement in node-positive women that may be considered hypothesis generating. If replicated in other studies, this could be a simple and inexpensive intervention, especially in developing countries where the incidence of lymph node metastasis is high.

scholarly journals Thoracic Paravertebral Blockade Reduces Chronic Postsurgical Pain in Breast Cancer Patients: A Randomized Controlled Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3539-3547
Author(s):  
Zeng-Mao Lin ◽  
Mu-Han Li ◽  
Feng Zhang ◽  
Xue Li ◽  
Chun-Li Shao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Breast Cancer Surgery ◽  
Control Group ◽  
Single Shot ◽  
Randomized Controlled ◽  
Chronic Postsurgical Pain

Abstract Objective To evaluate the effect of multilevel single-shot thoracic paravertebral blockade (PVB) on the occurrence of chronic postsurgical pain (CPSP) in patients undergoing breast cancer surgery. Design A randomized controlled trial with two parallel groups. Setting A tertiary hospital. Methods Patients scheduled for breast cancer surgery were randomized to receive either ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing (the control group). Surgery was then performed under general anesthesia. Patients were followed up for 12 months after surgery. The primary end point was incidence of CPSP at six months after surgery. Results A total of 218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively. The incidence of CPSP at six months was significantly lower in the PVB group (12.5% [13/104]) than in the control group (24.0% [25/104], relative risk = 0.52, 95% CI = 0.28–0.96, P = 0.031). Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P < 0.001, respectively). The percentages of patients with neuropathic pain were also lower in the PVB group than the control group at both six and 12 months after surgery (P = 0.016 and 0.028, respectively). Adverse events did not differ between groups. Conclusions For patients undergoing breast cancer surgery, multilevel single-shot PVB reduces the incidence of CPSP at six months; it also improves early postoperative analgesia and reduces neuropathic pain at six and 12 months after surgery.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

Randomized Controlled Trial of Mindfulness-Based Cancer Recovery Versus Supportive Expressive Group Therapy for Distressed Survivors of Breast Cancer (MINDSET)

2013 ◽  
Vol 31 (25) ◽  
pp. 3119-3126 ◽  
Author(s):  
Linda E. Carlson ◽  
Richard Doll ◽  
Joanne Stephen ◽  
Peter Faris ◽  
Rie Tamagawa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Social Support ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Stress Symptoms ◽  
Over Time

Purpose To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). Patients and Methods This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. Results Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). Conclusion In the largest trial to date, MBCR was superior for improving stress levels, quality of life, and social support for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.

scholarly journals 1032 Auricular Point Acupressure for Sleep Disturbance in Women With Breast Cancer: A Pilot Randomized Controlled Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A392-A392
Author(s):  
Y Wang ◽  
J Wu ◽  
J Li ◽  
J Zhou
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Controlled Trial ◽  
Control Group ◽  
Sleep Onset Latency ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Auricular Point ◽  
Pilot Randomized Controlled Trial

Abstract Introduction Sleep disturbance is reported in up to 60% of cancer patient. In traditional Chinese medicine, evidence suggests that auricular point acupressure (APA) improves sleep. However, little is known about APA’s effect on sleep disturbance in patients with breast cancer (BC). We tested the preliminary efficacy of APA on sleep in BC women undergoing chemotherapy. Methods A pilot randomized controlled trial was conducted in 41 BC patients (mean age=50±14) with self-reported poor sleep [Pittsburgh Sleep Quality Index (PSQI)≥7]. Participants were randomly assigned to an APA group (n=22) and a control group (n=19). All patients received sleep hygiene education. Additionally, for the APA group, magnetic pellets were attached to selected auricular points once a week for 3 weeks at the clinic, and the participants were instructed to self-press the pellets 4 times a day. Sleep were objectively measured by Actiwatch Spectrum and subjectively using PSQI at baseline and post-intervention. Paired t-tests and analyses of covariance using the variable baseline values were used to examine changes in sleep parameters. Results Twenty-one participants from the APA and sixteen from the control groups completed the study. Within the APA group, PSQI [mean difference (MD)=3.85, 95% Confidence Interval (C)=3.12~4.60] and sleep onset latency (MD=18.02, 95%CI=5.96~30.09) were significantly decreased, and the sleep duration (MD=-0.53, 95%CI=-0.99~-2.35) and sleep efficacy (MD=-5.00, 95%CI=-8.72~-1.28) were significant increased at post-intervention. Compared to the control group, participants in the APA group had significantly lower PSQI (F=30.77, p&lt;0.001) and greater sleep efficacy (F=5.25, p=0.028) at post-intervention. Conclusion APA may be an inexpensive and effective approach to improve sleep in patients with BC. More rigorous research with larger samples is needed to further test the efficacy of APA on promoting sleep in BC patients. Support None

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