loperamide

P2, N=315, Active, not recruiting, Spanish Breast Cancer Research Group | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2025 --> Oct 2024

Most MTC cases present with thyroid nodules in the initial steps and are confined to the thyroid gland or the adjacent LNs. These cases are mostly cured by thyroidectomy and LN dissection. This neuroendocrine cancer infrequently becomes aggressive and involves other parts of the body. However, involving BM or adrenal gland has been scarcely reported. Due to ineffective red and white blood cell production, BM metastasis can cause pancytopenia and, consequently, pallor, fatigue, dyspnea, and susceptibility to infections. High calcitonin levels can also cause diarrhea. The initial diagnosis is mostly with neck ultrasound (US) and fine needle aspiration (FNA). Total thyroidectomy is the main therapeutic option for these patients. Calcitonin and carcinoembryonic antigen (CEA) are sensitive indicators of recurrence or remaining tumors, which might be helpful for the initial diagnosis and postoperation follow-up. Although extremely rare, invasive metastasis of MTC might involve unusual body organs such as the BM or adrenal glands. In cases of unjustifiable pancytopenia or adrenal dysfunction in MTC-positive patients, these possibilities should be considered and ruled out by some specific evaluations, such as bone marrow biopsy and contrast-enhanced imaging.

From these results, loperamide and glipizide were identified as the best evaluated drugs. We suggest an in vitro analysis is needed to confirm our in silico prediction studies.

P2, N=60, Not yet recruiting, Convalife (Shanghai) Co., Ltd.

P4, N=150, Not yet recruiting, Weihai Municipal Hospital; Weihai Municipal Hospital

Acupuncture therapy has a positive effect on the rehabilitation of anal function after low-tension rectal cancer surgery; it can effectively help to improve the serum indices of patients, avoid the occurrence of anal incontinence, and reduce the incidence of complications. Popularizing and applying it will be valuable.

P4, N=150, Recruiting, Henry M. Jackson Foundation for the Advancement of Military Medicine | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Jun 2025

P1, N=80, Not yet recruiting, Ohio State University Comprehensive Cancer Center

P1, N=40, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025

Addition of trastuzumab (T) to N + fulvestrant (F) in HR+, HER2-negative, HER2-mutant mBC revealed increased efficacy compared to N+F [Jhaveri et al...Loperamide prophylaxis was mandatory during the first two cycles... Treatment with either N and/or N+T yielded promising clinical efficacy and has been included in recent NCCN guidelines for HER2-mutant, triple-negative mBC. Molecular mechanisms of intrinsic or acquired sensitivity/resistance per genomic analysis will be reported.

Similarly, all the crude extracts showed significant (p < 0.05) effects against pain centrally and peripherally compared to the standard drug morphine (2 mg/kg bw) and diclofenac sodium (50 mg/kg bw). Moreover, the methanol extract (400 mg/kg bw) manifested anti-diarrheal efficacy by inhibiting 72.0 % of the diarrheal episode in mice compared to the standard drug loperamide (inhibition = 80.0%)...Results from this study indicated that C. fistula might be a beneficial natural resource for treating diarrhea, hyperglycemia, and pain. However, additional research is required to conduct a comprehensive phytochemical screening and establish precise action mechanisms of the crude extract or the plant-derived compounds.

P1, N=198, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1

Furthermore, pyrotinib and neratinib were found to be higher in the risk of ≥ grade 3 diarrhea than lapatinib, however the risk could be reversed and prevented with loperamide. Pyrotinib is more valuable in clinics with better safety, effectiveness, economy, suitability, accessibility, and innovation in HER2-positive MBC. This study could provide references for the clinical application of HER2-TKIs in treating HER2-positive MBC.

P2, N=50, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting

The average number of weekly loose/watery stools were not different between the crofelemer BID and QID treatment groups (p = 0.84). This study showed that crofelemer prophylaxis reduced the incidence/severity of neratinib-associated diarrhea in female beagle dogs without the need for any loperamide administration.

P=N/A, N=52, Recruiting, Seoul National University Hospital

P2, N=315, Recruiting, Spanish Breast Cancer Research Group | Trial primary completion date: Dec 2023 --> Mar 2025

P1b, N=198, Active, not recruiting, Eli Lilly and Company | Trial completion date: Sep 2023 --> Dec 2024

Neratinib with high anticancer activity is indicated for the prolonged adjuvant treatment of HER2-positive early BC, or in combination with other drugs including trastuzumab, capecitabine, and paclitaxel for the treatment of advanced HER2-positive BC especially cancers with central nervous system (CNS) metastasis to reduce the risk of BC recurrence. The most common AE was diarrhea, and the incidence, severity and duration of neratinib-related grade 3 diarrhea can be reduced with loperamide. Of note, neratinib has the potential to effectively control and prevent brain metastasis in patients with advanced BC, providing a therapeutic strategy for HER2-positive BC.

This is the first study to investigate crofelemer for neratinib-induced diarrhea and demonstrates crofelemer activity in this setting. Further investigation of crofelemer for diarrhea secondary to cancer treatment is needed.

P2, N=234, Active, not recruiting, Eli Lilly and Company | Trial completion date: Sep 2023 --> Dec 2024

Probiotic Bifidobacterium or the combination of probiotic Bifidobacterium with TM did not decrease the incidence of grade 2 or greater diarrhea compared with historical control, although the grade 3 or greater diarrhea was reduced.

Most recently he received treatment with FOLFIRI and Cetuximab, with a FUDR hepatic arterial infusion pump...Broad spectrum antibiotics, scheduled diphenoxylate and loperamide were initiated with no improvement...Bowel movements improved with intravenous steroids which were transitioned to oral prednisone outpatient...Our case emphasizes standardized pre-therapeutic UGT1A1 testing due to the increased morbidity and mortality associated with IRI toxicity in these patients. It also highlights the need for closer monitoring for adverse drug events to reduce the overall healthcare burden and complications.

Symptomatic treatment alone or with loperamide, a low-fiber diet, and spasmolytics are recommended for low-grade diarrhea. In more severe cases, corticosteroid treatment is mandatory. In refractory cases, off-label use of biological therapies (infliximab or vedolizumab) was proposed.

In conclusion, ASBT downregulation is a possible mechanism responsible for the constipation-relieving effect of apples, and procyanidins may play a role in downregulating ASBT, which leads to the beneficial effects of apples against constipation. Although it is generally agreed that the common dietary compositions play a role in constipation relief, the novel specific mechanism of apples found in this study would facilitate understanding food functions.

The aim of this study was to prospectively evaluate the effectiveness of combined pelvic floor muscle exercises (PFMEs) and loperamide treatment on rectal function and mental health for low anterior resection syndrome (LARS) patients after sphincter-saving operation (SSO) for rectal cancer...Additionally, both anxiety scores (4.16 ± 1.38 vs. 5.33 ± 1.69, p < 0.001) and depression scores (4.09 ± 1.56 vs. 5.15 ± 1.89, p < 0.001) were significantly lower in Group A than in Group B at week 4. Pelvic floor muscle exercises are an effective treatment that can alleviate symptoms and improve rectal function and mental health in patients with low anterior resection syndrome.

In the C+F arm, medications for the management of AEs were used in 151/257 pts (59%) with diarrhea (mostly loperamide; n=135), 109/135 pts (81%) with rash (mostly antihistamines; n=75/topical corticosteroids; n=64), and 28/60 pts (47%) with hyperglycemia (mostly metformin; n=18). Diarrhea, rash, and hyperglycemia, the most commonly reported AEs associated with AKT pathway inhibition, occur early in treatment with C+F, are generally low grade and manageable, and are associated with low rates of dose modifications/discontinuations. Clinical trial information: NCT04305496. >aGroup terms (preferred terms): diarrhea (diarrhea, frequent bowel movements, gastrointestinal hypermotility); rash (rash, rash macular, maculopapular rash, rash papular, rash pruritic) and hyperglycemia (blood glucose increased, hyperglycemia).

Nonetheless, this toxicity leads to abemaciclib discontinuation in a small proportion of patients (approximately 2%) thanks to the use of effective loperamide-based supportive therapy. In our real-world analysis, we observed a higher incidence of diarrhea related to abemaciclib compared to data from clinical trials, and a higher rate of permanent treatment discontinuation due to gastrointestinal toxicity. Better implementation of guideline-based supportive care could help to manage this toxicity.

Goals : Neratinib (NER) is approved in Europe for the extended adjuvant treatment of HER2+/hormone receptor (HR)+ early breast cancer (EBC) patients (pts) within 1 year of trastuzumab (T)-based therapy completion...Arm A: NER (240 mg/day[d] × 1 year, 13 cycles [C]) + loperamide (LOP) (12 mg/d × 14 d→ 8 mg/d till end of C2→ as needed [PRN]), Arm B: NER dose escalation (120 mg/d × 7 d →160 mg/d till d 14→ 240 mg/d for a total of 13C) + LOP PRN, and Arm C: NER (like Arm A) + LOP (12 mg/d × 14 d→ 8 mg/d till end of C1→ PRN) + colesevelam (3750 mg/d × 28 d). Patients will be stratified by menopausal status and prior anti-HER2 therapy (T versus T + pertuzumab)... DIANER will take place in 110 sites in 5 European countries. As of 15/12/2022 is open in Spain with 14 patients recruited. Conclusion(s): NA

P2, N=50, Recruiting, MedSIR | Not yet recruiting --> Recruiting

These complete results from CONTROL show improved neratinib tolerability with proactive management at the start of therapy. Two-week neratinib DE with loperamide as needed was particularly effective.

P2, N=11, Completed, University of California, San Francisco | Active, not recruiting --> Completed

P2, N=315, Recruiting, Spanish Breast Cancer Research Group | Not yet recruiting --> Recruiting

Awareness of possible complications of systemic anti-cancer immunotherapy is crucial for patients safety. It is mandatory to consider immune-related adverse events, complicating infections, bile acids malabsorption and small intestinal bacterial overgrowth syndrome. Prompt proper dia gnostics and immediate vigorous therapy infl uence the outcome of patients signifi cantly. A strictly individualized approach is indispensable.

The curative effect and safety of modified BSS were statistically significant.

Cobimetinib is approved for use with vemurafenib in the U.S. and Europe for advanced melanomas harboring BRAF mutations...One pt required hydroxyurea (HU) for cytoreduction prior to starting cobimetinib...The most common treatment related AE was diarrhea (83%), all cases of which were Grade 1 or 2 and easily managed with the addition of loperamide... Oral cobimetinib showed single agent activity (ORR 50%) and safety in a small number of CMML patients. Accrual for NCT04409639 is ongoing and multisite opening is in progress. Correlative studies, including measurement of circulating inflammatory cytokine levels and mutant allele burden are ongoing and will be presented.

P2, N=50, Not yet recruiting, MedSIR | Initiation date: Oct 2022 --> Jan 2023

She was started on a proton-pump inhibitor (PPI), colestipol, and loperamide without improvement. The gastric pH, gastric level, secretin stimulation, and Dotatate PET/CT are used to evaluate and localize the tumor. Figure: Figure 1A, 1B: Computed Tomography (CT) abdomen showed multiple, small duodenal ulcers and 4 millimeter (mm) enhancing polyp at the gastric antrum (red arrows)

She was given loperamide and colestipol for mild persistent diarrhea. The neoplastic cells are positive for CD20, CD10 and bcl-2 C- t(14;18)(q32;q21) (IGH/BCL2) translocation is detected by FISH. One green, one orange and two yellow fusion signals (x1000)

P2, N=50, Not yet recruiting, MedSIR

The genetic analysis suggests that she may have a germline mutation at unscreened region of these genes or in unidentified FAP gene. The patient will be carefully followed up for residual rectal carcinoma and for the development of other cancers.

P2, N=315, Not yet recruiting, Spanish Breast Cancer Research Group | Initiation date: Jul 2022 --> Oct 2022