Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

single-fraction SRS

high-dose hypofractionated SRS

Quality of Life Measures

Ilya Laufer

The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.

Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.

Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)

Johns Hopkins University

Massachusetts General Hospital

Stanford University

Memorial Sloan Kettering Cancer Center

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

high-dose hypofractionated SRS

Quality of Life Measures

High-dose Hypofractionated SRS (27 Gy in 3 Fractions)

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

single-fraction SRS

Quality of Life Measures

Single-fraction SRS (24 Gy)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ilya Laufer, MD

Local Tumor Control Using MRI or CT

Treatment-related Toxicity Using CTCAE v4.0

Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI

Overall Study

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

All Drugs and Chemicals

Antihypertensive Agents

Channel Blockers

Bone Density Conservation Agents

Vasodilator Agents

Calcium

Diuretics

Calcium Channel Blockers

Angiotensin Receptor Antagonists

Calcium, Dietary

Adrenergic beta-Antagonists

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

SBP control will consist of treatment with antihypertensive medications titrated every 4 weeks for the first 3 months, and then every 3 months in months 4-12. SBP control will be achieved by titration of antihypertensive medications based upon a standardized algorithm and will be implemented during a 12-month study period. At the time of randomization, no antihypertensive treatments may be initiated or modified if SBP is ≥160 mm Hg. The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

Patients randomized to intensive SBP control will be treated to achieve an SBP goal \<120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal \<140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.The clinical context may be considered at each visit to inform decision-making regarding treatment initiation or modification, at the discretion of the treating provider.

One or more of the following medications may be used in both randomization groups to achieve SBP goals:

* Angiotensin converting enzyme inhibitors (ACEI)
* Angiotensin receptor blockers (ARBs)
* Beta-blockers (BB)
* Thiazide-type diuretics
* Calcium channel blockers
* Aldosterone antagonists
* Alpha1-receptor blockers.
* Direct vasodilators
* Loop diuretics

antihypertensive medications

Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).

Blood pressure measurement

Echocardiogram

Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.

Symptom-limited cardiopulmonary exercise test

FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.

Research blood samples will be collected at baseline, 3 months, and 6 months

Biomarkers

Anthony Yu, MD

Jennifer Liu, MD

The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer.

The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.

This open-label, two-arm RCT will compare the effects of intensive versus standard SBP control in patients with BC and HTN receiving anthracycline-based treatment (with or without HER2-targeted therapy).

A Study of Blood Pressure Control During Cancer Treatment

Intensive Blood Pressure Control During Cardiotoxic Breast Cancer Treatment (PROTECT), A Randomized Controlled Trial

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Antineoplastic Agents

Lenalidomide

Daratumumab

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Those randomized to lenalidomide maintenance will receive a maintenance dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.

ARM A1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their lenalidomide maintenance schedule per study calendar.

ARM A2: The patients who do not go on the nutrition sub study will continue on their lenalidomide maintenance schedule per study calendar.

Those randomized to receive daratumumab maintenance will receive 1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.

ARM B1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their daratumumab maintenance schedule per study calendar.

ARM B2: The patients who do not go on the nutrition sub study will continue on their daratumumab maintenance schedule per study calendar.

dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle.

1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36

EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)

Questionnaires

The intervention, consisting of fully prepared whole foods plant based (WFPBD) meals and behavioral coaching provided by the company Plantable. Patients receive self-selected WFPBD meals (lunch/dinner) for 12 weeks, along with guidance for snacks and breakfast. Behavioral counseling will be provided by health coaches and a research dietitian. The first 15 participants on each arm interested in this intervention will be enrolled on C13D1 or C25D1.

Dietary Intervention

Urvi Shah, MBBS

Sham Mailankody, MBBS

The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. The researchers will compare giving the usual maintenance therapy (lenalidomide) with giving daratumumab as maintenance therapy, and they will look at which drug gives participants a better health-related quality of life during treatment. The researchers will measure participants' quality of life using various questionnaires. This study will help researchers find out whether this different approach of giving daratumumab as maintenance therapy is better, the same as, or worse than the usual approach.

This is a two-arm randomized pilot study.

A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide

Daratumumab Versus Lenalidomide Maintenance Therapy for Multiple Myeloma: A Randomized Pilot Study Comparing Patient-Reported Health Related Quality of Life Measures With a Plant Based Nutrition Intervention Sub Study (NUTRIVENTION-4)

The primary comparison across the two treatment arms will use a mixed effects linear regression model.

Evaluation using traditional IMWG uniform response criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases	NCT02320825	Spinal Metastas...	single-fraction... high-dose hypof... Quality of Life...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Blood Pressure Control During Cancer Treatment	NCT06023576	Breast Cancer Cardiotoxicity	antihypertensiv... Blood pressure ... Echocardiogram Symptom-limited... Quality of Life... Biomarkers	18 Years -	Memorial Sloan Kettering Cancer Center
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases	NCT02320825	Spinal Metastas...	single-fraction... high-dose hypof... Quality of Life...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide	NCT04497961	Multiple Myelom...	Lenalidomide Daratumumab Questionnaires Dietary Interve...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for quality of life measures