Chemotherapy Side Effect

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 PET/CT 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 a new device called the Paxman Limb Cryocompression System (PLCS) to study its safety and effectiveness in preventing chemotherapy-induced peripheral neuropathy in cancer patients. This condition can cause nerve damage and discomfort during cancer treatment. The study will enroll 80 cancer patients receiving weekly paclitaxel chemotherapy, with some also receiving other chemotherapy drugs like Platinum or Herceptin. During the study, participants will undergo limb cryocompression using cooling wraps connected to the PLCS device. The cooling will be applied from the fingers or toes up to the elbow or knee during each chemotherapy cycle. Each cryocompression session will last up to four hours, including 30 minutes before and 30 minutes after chemotherapy infusion. Patients may continue treatment for up to 12 cycles or longer with their doctor's approval. Participants will be closely monitored for any treatment-related side effects using a standard scale over four months. Researchers will also assess symptom changes related to neuropathy over 16 months using a quality of life questionnaire. Patients will complete a usability survey about the PLCS device during the study. The total participation time varies with chemotherapy cycles, and safety will be carefully tracked throughout the study period.

Researchers are evaluating the effectiveness and safety of using Trilaciclib to prevent chemotherapy-related myelosuppression in patients with Ewing's 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 Ewing's sarcoma. The study compares the use of Trilaciclib combined with standard VDC+IE chemotherapy versus chemotherapy alone. Participants will be randomly assigned to one of two groups: the experimental group receiving Trilaciclib along with alternating VDC+IE chemotherapy every 3 weeks for up to 17 cycles, or the control group receiving only the alternating VDC+IE 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 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 1/2, 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.

This clinical trial investigates whether a virtually delivered diet intervention called LASO-3 can help improve chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors after treatment. CIPN is nerve damage caused by chemotherapy that leads to numbness, tingling, or pain in the hands or feet, and currently, there are few treatments available. The LASO-3 diet focuses on reducing added sugar intake, increasing fiber, and boosting omega-3 fatty acids to reduce inflammation, which may contribute to CIPN. Participants are randomly assigned to one of two groups. One group receives virtual LASO-3 nutrition counseling sessions led by a Registered Dietitian over 12 weeks, starting with weekly 30-minute sessions for 4 weeks, followed by biweekly 15-minute sessions for 8 weeks. The other group attends eight virtual general health education sessions lasting 15 to 30 minutes over 12 weeks, and may receive intervention materials and up to four dietary counseling sessions after the study. Blood samples are collected from all participants throughout the trial. Participants complete patient-reported outcome measures at the start and after 12 weeks. Researchers track recruitment, session attendance, and self-reported adherence to the diet goals, as well as acceptability and satisfaction with the intervention. The trial lasts up to 24 weeks and involves regular virtual sessions, blood collections, and surveys to assess the impact of the diet on CIPN symptoms in post-treatment cancer survivors.

The trial investigates hearing loss prevention in adult male patients with testicular cancer who are scheduled to receive cisplatin-based chemotherapy. It aims to evaluate the safety, effectiveness, and tolerability of ACOU085, a drug administered directly into the middle ear to reduce the risk of sensorineural hearing loss caused by cisplatin treatment. This phase IIa, randomized, double-blind, placebo-controlled study is conducted at multiple centers and includes men aged 18 to 45 years. Participants will receive three transtympanic injections of ACOU085 into one ear and a placebo injection into the other ear before each of the three planned chemotherapy cycles, each lasting three weeks. This split-body design allows comparison of the active drug with placebo within the same patient. The injections target the round window niche of the middle ear and are scheduled to match the chemotherapy cycles. Throughout the study, participants will undergo hearing assessments including pure tone audiometry (PTA) air measurements at 9 weeks and additional tests such as distortion product otoacoustic emissions, PTA bone conduction, and speech understanding tests up to 150 days. Safety parameters like heart rate, blood pressure, ECG, and laboratory tests will be monitored. The trial runs from December 2023 to September 2025, with ongoing evaluation of hearing function and safety outcomes.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and challenging side effect for breast cancer patients receiving taxane-based chemotherapy. It can cause long-lasting nerve symptoms that affect quality of life and may lead to changes or stopping of cancer treatment. Currently, there are no widely recommended preventive treatments, though compression therapy and acupuncture have shown promise. This trial aims to evaluate the preventive effects of compression therapy, acupuncture, and their combination to provide better evidence for tailored prevention strategies. Participants are randomly assigned to one of four groups: compression therapy alone, acupuncture alone, combined compression and acupuncture, or sham acupuncture as a placebo. Compression involves wearing latex gloves and compression stockings during chemotherapy sessions. Acupuncture is delivered electrically for 3 to 5 days after each chemotherapy cycle at specific acupoints. The combined group receives both compression during chemotherapy and acupuncture afterward. The sham group receives superficial needling at non-acupoint sites without stimulation. During the study, participants are monitored closely with regular assessments of nerve symptoms, motor and sensory function, quality of life, and nail toxicity at multiple time points during and after chemotherapy. Researchers also track any side effects related to the interventions over an 8-month period. The main measure is the occurrence of moderate or worse CIPN symptoms 12 weeks after starting chemotherapy. This study is designed to last from chemotherapy initiation through 24 weeks post-treatment to fully evaluate the interventions' effects and safety.