Double blind randomized controlled trial of efficacy of ormeloxifene for the treatment of fibroadenoma (The FIBROCENT study).

BACKGROUND: We evaluated the effectiveness of Ormeloxifene (Centchroman) on regression of Fibroadenoma in a double-blind randomized controlled trial. METHODS: Patients with biopsy proven Fibroadenoma were enrolled between March 2023 and October 2023 and divided in two arms- Ormeloxifene group and Placebo group. Effectiveness of the treatment was evaluated using USG. No residual mass was defined as complete regression and more than 30% decrease in size was considered as partial regression. RESULTS: A total of 130 consecutive patients with Fibroadenoma were randomized to Ormeloxifene group (n = 65) and Placebo Group (n = 65). Complete regression was observed in 9% (6/65) patients in Ormeloxifene group and 10.8% (7/65) in Placebo Group at the end of 12 weeks (p = 0.49). Twenty one patients taking Ormeloxifene reported adverse events as compared to none in the other group. CONCLUSION: In our study Ormeloxifene was not found to be effective in treatment of fibroadenoma and had concerning side effects.

Patient Perspectives After Surgery-Related Complications Among Breast Cancer Patients from a LMIC.

Long-term quality of life in breast cancer patients has been studied and published regularly. However, the lived experiences of patients who develop complications after surgery are not well understood. Determining this experience of patients is challenging in most low- and middle-income countries where the majority of patients belong to poor strata of society and are uneducated. We aimed to explore the thoughts, feelings, and experiences of patients with surgery-related complications after breast cancer surgery. Purposive sampling was used to identify patients who developed any postoperative complication, and semi-structured interviews were conducted. Common patterns of patient experiences were identified and analyzed using descriptive thematic analysis. Twenty-eight patients out of 210 developing complications postoperatively were identified. The median age was 48 years (range 32-65 years). The majority (n = 26) were housewives, educated below the primary level (n = 11) and below the poverty line (n = 13). Complications included seroma (n = 17), flap necrosis and infection (n = 5), and hematoma (n = 1). Seven domains emerged from the interviews-knowledge of complications, psychological impact, burden, disruptiveness, social impact, relationship with the surgical team, and suggestions to improve the experience. The themes identified in the present study provide insights into the lived experiences and can inform the future development of patient-reported outcome measures and quality improvement programs, including more effective pre-operative counseling and consent. Supplementary Information: The online version contains supplementary material available at 10.1007/s13193-023-01721-z.

Open-Label Three Arm Trial Comparing Ormeloxifene, Gamma Linolenic Acid With Methylcobalamine + Vitamin C and Placebo in Mastalgia.

Objective: We evaluated the beneficial effect of Ormeloxifene (Centchroman) versus a combination of Gamma Linolenic acid (GLA), methylcobalamine and vitamin C on mastalgia in a three-arm, open-label, placebo-controlled trial. Materials and Methods: Patients aged above 18 years with mastalgia were recruited between January 2019 and July 2021. Patients were divided in three arms: Ormeloxifene arm, GLA arm and Placebo arm. Response was evaluated using visual analogue scale (VAS) and score below 3/10 was defined as complete relief. Results: A total of 113 consecutive women with mastalgia were randomized to the GLA group (Group 1, n = 39 women), Ormeloxifene (Group 2, n = 36) and Placebo (Group 3, n = 38). Complete response was observed in 94% patient in Group 1, 96% in Group 2 and 87% in Group 3 at the end of 12 weeks and it was not significant (p = 0.49). Adverse events were reported by eleven patients taking Ormeloxifene, compared to none in the other two groups. Conclusion: In this study Ormeloxifene and GLA were not superior to placebo for pain relief in mastalgia. Furthermore, there were concerning side effects associated with Ormeloxifene therapy. The role of Ormeloxifene in mastalgia needs further evaluation before recommending it as preferred therapy.

Validation sentinel lymph node biopsy study in cN0 axilla using low-cost dual dye technique: potential solution for resource poor settings.

BACKGROUND: Sentinel lymph node biopsy (SLNB) using radio-pharmaceutical and a blue dye is gold standard for axillary staging in clinically node-negative breast cancer. High costs and limited availability of radio-pharmaceutical and/or gamma probe are major deterrents in performing SLNB in developing countries. In this study, we evaluated feasibility of SLN identification (SLN-IR) of fluorescein-guided (FG) SLNB in combination with methylene blue dye (MBD). METHODS: This was a prospective cross-sectional non-randomized validation study in patients with clinically node-negative axilla. Patients underwent validation SLNB using fluorescein (and blue LED light) and MBD. Axillary dissection was performed irrespective of SLNB histology. SLIN-IR and False Negative Rate (FNR) were assessed for both groups. RESULTS: The SLNs were identified in 29 (96.6%) pre-chemotherapy patients and 23 (82%) post Neoadjuvant Chemotherapy (NACT) patients. The median number of sentinel lymph nodes identified was 3 (range of 1-5) in pre-chemotherapy patients and 1 (range of 1-3) in post NACT patients. The SLN-IR using MBD was 90%, FD was 86.7% and combined MBD FD was 96.7% in pre-chemotherapy patients. The SLN-IR using MBD was 82%, FD was 71% and combined MBD FD was 82% in in post NACT patients. The false negative rate (FNR) in pre-chemotherapy group was 8.0% (MBD), 8.3% (FD) and 7.4% (MBD + FD). The FNR in post NACT group was 8.7% (MBD), 10% (FD) and 8.7% (MBD + FD). CONCLUSION: This prospective validation study showed adequate SLN-IR and FNR using low-cost dual dyes in early breast cancer patients and can be used in low resource settings. However, SLNB in post NACT axilla though viable along with a satisfactory FNR, is associated with low identification rate and needs further evaluation.

Histopathological Comparison of Mosquito Net with Polypropylene Mesh for Hernia Repair: An Experimental Study in Rats.

Use of mosquito net, in place of polypropylene mesh, had been reported for tension-free hernia repair, as a better cost-effective option. This experimental histopathological study was performed in rats to find out the tissue response and the foreign body reaction and its comparison between commercial polypropylene mesh and the sterilized mosquito net. This experimental study was conducted in the Department of Surgery, Government NSCB, Medical College, Jabalpur (Madhya Pradesh), India. It was carried out in 40 albino rats. A 1.5 × 0.5-cm hernial defect was created by excising full-thickness abdominal wall muscle. All rats underwent on-lay mesh repair of hernial defect (polypropylene mesh, n = 20; mosquito net, n = 20). Half of rats in each group were sacrificed on day 14, and the other half, on day 90. Sections of containing mesh were examined histopathologically for inflammatory infiltrate, giant cells, and collagen deposition. Mosquito net group showed significantly greater number of giant cells and inflammatory cells at 14 and 90 days (p < 0.0001, p < 0.001, p < 0.05, and p < 0.001, respectively), as compared to polypropylene group. Grades of collagen fiber deposition were almost equal in both groups, both at 14 and 90 days (p > 0.05 and p > 0.05, respectively). Results of mosquito net are comparable to conventional polypropylene mesh. In a setup, where cost-effectiveness is of primary importance, use of mosquito net for tension-free hernia repair can be an acceptable alternative as proven histologically, to commercially available polypropylene mesh.