Chemotherapy Side Effect

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

Researchers are evaluating resectability rates and survival outcomes in patients with borderline resectable and locally advanced pancreatic cancer who receive primary chemotherapy. This nationwide Norwegian single-arm prospective study follows national guidelines for diagnosis, oncological treatment, surgery, and follow-up. The goal is to achieve a 50% resection rate in borderline resectable pancreatic cancer and 15% in locally advanced cases, aiming for adequate overall survival and controlled morbidity and mortality after surgery. Participants will receive primary chemotherapy according to national guidelines, preferably using mFOLFIRINOX or gemcitabine-nab-paclitaxel regimens. Surgical exploration and resection may follow chemotherapy, with surgery scheduled within four weeks after the last neoadjuvant infusion. Surgical procedures include pancreatoduodenectomy, distal pancreatectomy with splenectomy, or total pancreatectomy with splenectomy, possibly involving venous or arterial resection and reconstruction. Diagnostic procedures include endoscopic ultrasound fine-needle biopsy for diagnosis and molecular pathology and optional PETCT scans at baseline and after two months of chemotherapy. Participants will be assessed regularly with quality of life questionnaires at baseline, 3, 6, and 12 months from diagnosis, then yearly thereafter. Researchers will monitor resection rates, overall survival, mortality and morbidity after surgery, adverse events, and molecular pathology markers. The study collects data from November 2023 through December 2027, with a focus on surgical outcomes and patient well-being following treatment.

Researchers are evaluating the safety and effectiveness of a new limb cryocompression device called the Paxman Limb Cryocompression System PLCS in preventing chemotherapy-induced peripheral neuropathy in cancer patients. This study involves 200 cancer patients receiving weekly paclitaxel chemotherapy, aiming to develop a therapy that reduces nerve damage caused by chemotherapy. The trial is sponsored by the National University Hospital, Singapore, and includes participants aged 21 to 80 years. Participants will undergo limb cryocompression treatment during each chemotherapy cycle using cooling wraps that cover the limbs from the digits to the elbow or knee. The therapy involves 30 minutes of cooling before chemotherapy infusion, continued cooling during chemotherapy, and 30 minutes after infusion, totaling up to 4 hours per cycle. This cryocompression treatment is repeated for up to 12 cycles, with the possibility of extension after consultation with the principal investigator. Throughout the study, participants will be monitored for treatment-emergent adverse events using established criteria over a 4-month period and assessed for changes in neuropathy symptoms using a quality-of-life questionnaire over 16 months. Usability of the PLCS device will also be evaluated. Monitoring will include repeated safety and symptom assessments during and after cryocompression treatment, with the total study duration extending up to 16 months.

Researchers are evaluating the effectiveness and safety of using Trilaciclib to prevent chemotherapy-related myelosuppression in patients with Ewings sarcoma who have not previously received systemic anti-tumor treatment. This is a phase 2, prospective, randomized, controlled clinical trial focusing on patients aged 14 to 40 years with confirmed Ewings sarcoma. The study compares the use of Trilaciclib combined with standard VDCIE chemotherapy versus chemotherapy alone. Participants will be randomly assigned to one of two groups the experimental group receiving Trilaciclib along with alternating VDCIE chemotherapy every 3 weeks for up to 17 cycles, or the control group receiving only the alternating VDCIE chemotherapy on the same schedule. The chemotherapy regimen includes vincristine, doxorubicin or actinomycin D after a certain cumulative dose, cyclophosphamide, ifosfamide, and etoposide. Trilaciclib is given as an intravenous infusion following chemotherapy administration in the experimental group. Supportive care is allowed in both groups as needed. During the treatment, participants will be monitored for myelosuppression effects such as neutropenia and thrombocytopenia through laboratory tests. The primary outcome measures how long severe neutropenia lasts in the first treatment cycle, with additional outcomes tracking recovery times, incidence of febrile neutropenia, anemia, and serious infections across multiple cycles. The study will also assess event-free survival up to 24 months. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The total study duration includes up to 17 cycles of treatment and follow-up assessments.

Researchers are evaluating the effects of Nuvastatic 300 capsule on reducing fatigue related to cancer treatment in adults with metastatic colon cancer who are undergoing first-line chemotherapy. The main goals are to determine if Nuvastatic 300 capsule can significantly reduce cancer-related fatigue compared to a placebo and to assess its safety and tolerability in this patient group. This is a phase III randomized, double-blind, placebo-controlled study sponsored by Natureceuticals Sdn Bhd. Participants will receive either Nuvastatic 300 capsules or placebo capsules, taken three times daily for six cycles lasting about 20 days each, totaling approximately 120 treatment days. All participants will continue their standard chemotherapy during the trial. Blood samples will be collected at screening and at the end of treatment to monitor health and treatment effects. During the study, participants will complete diaries and fatigue assessments according to the protocol. Researchers will measure reduction in cancer-related fatigue from screening to the end of treatment, as well as overall quality of life and functional improvements. The trial includes safety monitoring and will last about six months from screening through treatment completion.

Researchers are studying whether an intensive approach to controlling high blood pressure is safe and more effective than standard treatment in lowering blood pressure and reducing the risk of heart damage during breast cancer treatment. This trial focuses on patients with breast cancer undergoing treatment with anthracycline-based chemotherapy and compares two systolic blood pressure SBP goals without testing specific medications. Participants are randomly assigned to one of two groups one aiming for intensive blood pressure control with an SBP goal below 120 mm Hg, and the other aiming for standard control with an SBP goal below 140 mm Hg. Antihypertensive medications, including various types such as ACE inhibitors, beta-blockers, diuretics, and others, will be adjusted every 4 weeks for the first 3 months and then every 3 months up to 12 months. All participants receive dietary and lifestyle advice to help manage blood pressure. During the study, participants will have their blood pressure monitored at home and in clinic visits, along with echocardiograms at baseline, 6 months, and 12 months to assess heart function. Some participants may undergo cardiopulmonary exercise tests. Quality of life questionnaires and blood samples for biomarker analysis will also be collected. The main outcome measured is the change in systolic blood pressure from the start of the study to 12 months. The study lasts for one year, with regular follow-ups to evaluate treatment effects and safety.

Researchers are studying the effects of local treatment on health and daily life in people with early-stage breast cancer in China. The focus is on those with stage I to III invasive breast cancer receiving surgery and other therapies before or after surgery. The study aims to understand both short- and long-term physical, emotional, and social effects of treatment, including tiredness, sleep problems, emotional distress, pain, and changes in heart or lung function, to improve recovery and quality of life. Participants will receive local therapy with curative intent, which may include surgery, chemotherapy, radiotherapy, endocrine therapy, or targeted therapy given before or after surgery. This observational study involves no experimental treatment. At the start, participants undergo clinical assessments, including heart and lung tests, lab work, and collection of blood and tissue samples. They also complete questionnaires about symptoms and well-being at multiple time points over five years. During the study, participants will complete surveys about their physical symptoms, emotional health, and quality of life at baseline, one week, one month, three months, six months, one year, and then annually up to five years. Researchers will monitor treatment-related toxicities and quality of life changes through these patient-reported outcomes. The study uses electronic data collection with quality checks to ensure accurate and consistent information for analysis and future research.

Researchers are investigating the impact of photobiomodulation PBM, also known as low level laser therapy, on the occurrence and severity of oral mucositis in patients who have undergone surgery for oral cancer and are receiving radiotherapy with or without chemotherapy. This study aims to understand if PBM can reduce oral mucositis, a painful condition affecting the mouth lining during cancer treatment. Participants will receive PBM treatment five times a week during their radiotherapy sessions. After completing radiotherapy, those who still have oral mucositis may continue PBM treatment until the condition resolves, with treatment frequency adjusted by the study team. PBM is applied within and around the oral cavity using a laser device. During the study, participants will be monitored for the development and severity of oral mucositis over about one year. Researchers will also assess pain levels, quality of life, use of pain medication, ability to eat normally, mouth opening restriction trismus, and hospitalization rates. The study includes regular evaluations to track these outcomes and monitor safety throughout the participation period.

Researchers are evaluating the safety and potential effectiveness of a topical treatment called ATR04-484 for patients experiencing moderate to severe skin rash caused by EGFR inhibitor therapy. This Phase 12, multicenter, randomized, and blinded trial compares ATR04-484 to a placebo vehicle in adults with EGFRi-related dermal toxicity primarily affecting the face, and possibly the neck, chest, and back. The study aims to assess the safety, bioavailability, pharmacodynamics, and preliminary treatment effects of ATR04-484. The trial involves two patient cohorts. The first cohort receives a single 4 g application of ATR04-484 or vehicle to the affected areas followed by a 7-day observation period, potentially continuing with daily applications for 28 days. The second cohort receives daily 4 g applications for 28 days. Both cohorts are followed for 28 days after completing treatment. Clinical assessments will evaluate skin toxicity severity, itching, pain, and quality of life using standardized scales. Participants will apply the study treatment daily as directed and attend clinic visits for evaluations and sample collections. Researchers will monitor safety and tolerability as the primary outcome over 57 days, along with secondary measures including skin rash severity, pruritus, and quality of life. Bioavailability of the topical agent will also be assessed. The study duration includes treatment and follow-up periods to thoroughly monitor effects and safety.

Researchers are evaluating a virtually delivered diet intervention called LASO-3 to improve chemotherapy-induced peripheral neuropathy CIPN in cancer survivors after treatment. CIPN causes nerve damage resulting in numbness, tingling, or pain in the hands or feet and currently has limited treatment options. The study focuses on dietary changes that may reduce inflammation, which contributes to CIPN symptoms, aiming to support cancer survivors recovery and quality of life. The LASO-3 intervention involves virtual nutrition education sessions led by a Registered Dietitian. The diet targets lowering added sugar to less than 10% of daily calories, increasing fiber intake to at least 20 grams daily, and boosting moderate to high omega-3 seafood consumption or plant-based omega-3 sources. Participants in the LASO-3 group receive weekly 30-minute counseling sessions for 4 weeks followed by biweekly 15-minute sessions for 8 weeks. The study also includes a comparison group receiving general health education sessions virtually over 12 weeks. Blood samples are collected from all participants throughout the trial. Participants complete patient-reported outcome questionnaires at baseline and 12 weeks to assess feasibility and adherence. Researchers measure recruitment success, session attendance, and self-reported diet adherence over 24 weeks. Satisfaction with the intervention is also evaluated at 12 weeks. The study aims to gather information on the practicality of delivering this diet program virtually and its potential to manage CIPN symptoms. The trial is expected to continue until March 2028.