Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Hot Flashes

Menopause

The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations (4). They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies (5, 6). The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.

The sham comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash. A previously published report provides additional details and data indicating this program was a suitable attention control.

The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.

Paced respiration

Sham comparator: fast shallow breathing

Janet S Carpenter, PhD, RN

Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence.

Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms.

Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area.

Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries.

Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment.

Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.

Breathe for Hot Flashes Randomized Controlled Trial

Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference

De-identified data available upon request.

Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.

Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.

Number of breathing practice sessions per participant over the 16 week study period.

Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.

Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.

Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.

Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.

Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.

Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.

Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Indiana University

The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.

Paced Respiration

The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.

Fast, Shallow Breathing

Usual Care

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Breast Cancer Survivor

Menopausal Women with No Cancer History

Breast cancer survivors \> 4 weeks post-completion of surgery, radiation, and/or chemotherapy for nonmetastatic breast cancer with no additional cancer history OR menopausal women with no cancer history

Breast Cancer History

Hot Flash Frequency

Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages.

Hot Flash Severity

Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages.

Hot Flash Bother

Self-report using well-validated, standardized questionnaire. Subject rated interference items on scale from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.

Hot Flash Related Daily Interference

Perceived Control Over Hot Flashes

Mood Disturbance

Sleep Disturbance

Janet S Carpenter, PhD, RN, FAAN

Analysis based on all randomized participants.

Intervention Performance

Intervention Adherence

Overall Study

Infections

Blood and Lymph Conditions

Immune System Diseases

Wounds and Injuries

Rare Diseases

Syndrome

Recurrence

Leukemia

Fatigue

Communicable Diseases

Body Weight

Leukemia, Lymphoid

Neoplasm Metastasis

Anemia

Thrombocytopenia

Weight Loss

Hyperthermia

Lymphadenopathy

Leukemia, Lymphocytic, Chronic, B-Cell

Fever

Leukemia, Prolymphocytic

Lymphocytosis

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Body Weight Changes

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Blood Platelet Disorders

Cytopenia

Leukocytosis

Leukocyte Disorders

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Richter Syndrome

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.

Ex Vivo-activated Autologous Lymph Node Lymphocytes

Laboratory Biomarker Analysis

Chitra Hosing

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)

Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.

To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia

The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.

To study the incidence of infections for up to 1 year following activated T cell infusion

M.D. Anderson Cancer Center

Patients who qualify for lymphodepleting chemotherapy and who do not have 17p deletion are randomized to Arm A or Arm B. Those patients who do not qualify by those criteria are assigned to Arm C.

Receive lymphodepletion chemotherapy followed by activated T-cell infusion

Arm A

Receive lymphodepletion chemotherapy followed by activated T-cell infusion followed by low dose lenalidomide PO once ANC is\>1.5x109/L

Arm B

Patients who cannot receive lymphodepleting chemotherapy (as determined by the treating physician) or those with 17p deletion

Arm C

Age, Categorical

All patients were enrolled in Arm C at the physician's discretion and there is no analysis to compare between the lenalidomide Arm A vs the non-lenalidomide Arm B

Dr. Chitra Hosing / Stem Cell Transplantation

Sucessful Target T-cell Dose

Feasibility

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.

Data was not collected due to low accrual

Immune Reconstitution

Overall Response Rates

Incidence of Infections

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Splenomegaly

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Hypertrophy

Pathological Conditions, Anatomical

Hypoglycemic Agents

All Drugs and Chemicals

Anti-Infective Agents

Metformin

Ritonavir

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

SINGLE AGENT STAGE : Patients receive metformin hydrochloride PO BID on days 1-7 in the absence of disease progression or unacceptable toxicity.

COMBINATION REGIMEN STAGE: Patients receive metformin hydrochloride PO BID and ritonavir orally PO BID on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Metformin Hydrochloride

Pharmacological Study

Quality-of-Life

Questionnaire

Nitya Nathwani, MD

This pilot clinical trial studies the side effects and best dose of metformin hydrochloride and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that has returned after a period of improvement or has not responded to treatment. Metformin hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To assess the safety, tolerability and feasibility of administering metformin hydrochloride (metformin)/ritonavir combination therapy in patients with relapsed/refractory multiple myeloma or relapsed/refractory chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To characterize the clinical activity of this two-drug combination by assessing disease response, response duration, and (in relapsed/refractory multiple myeloma \[RRMM\]) clinical benefit response.

II. To assess the progression-free survival, overall survival and compliance of all patients who start the two-drug combination.

III. To evaluate potential changes in health-related quality of life, as assessed by the Functional Assessment of Cancer Therapy for Multiple Myeloma (FACT-MM) and Leukemia (FACT-Leu).

TERTIARY OBJECTIVES:

I. To describe the plasma pharmacokinetics of metformin and ritonavir when given in combination.

II. In relapsed/refractory chronic lymphocytic leukemia (RRCLL), to describe changes in pAKT, pAMPK, and MCL-1, in circulating lymphocytes in response to treatment.

OUTLINE: This is a dose escalation study.

SINGLE AGENT STAGE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-7 in the absence of disease progression or unacceptable toxicity.

COMBINATION REGIMEN STAGE: Patients receive metformin hydrochloride PO BID and ritonavir PO BID on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 28 days.

Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

A Pilot Feasibility Study of Metformin/Ritonavir Combination Treatment in Patients With Relapsed/Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

Observed toxicities will be summarized, for all patients based on highest achievable dose, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

Will be categorized using International Myeloma Working Group (IMWG). Will be calculated, for the initial and sub-analysis for all dose levels; Copper Pearson binomial 95% confidence intervals will be calculated for these estimates. Will be evaluated based on number/type of prior therapy(ies).

Will be categorized using IMWG. Clopper Pearson binomial 95% confidence intervals will be calculated. Will be evaluated based on number/type of prior therapy(ies).

The Functional Assessment of Cancer Therapy for Multiple Myeloma and Leukemia will be scored using published guidelines.

Will be estimated using the product limit method of Kaplan Meier.

First documented response is defined as stringent complete response, complete response, very good partial response, or partial response.

Will be categorized using IMWG. Will be estimated using the product limit method of Kaplan Meier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breathe for Hot Flashes Randomized Controlled Trial	NCT00819182	Hot Flashes	Paced respirati... Sham comparator...	18 Years -	Indiana University
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia	NCT02530515	Anemia Cancer Fatigue Chronic Lymphoc... Fever Infectious Diso... Lymphadenopathy Lymphocytosis Night Sweats Prolymphocytic ... Recurrent Chron... Richter Syndrom... Secondary Malig... Thrombocytopeni... Weight Loss	Ex Vivo-activat... Laboratory Biom...	-	M.D. Anderson Cancer Center
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	NCT02948283	Anemia Fatigue Fever Lymphadenopathy Lymphocytosis Night Sweats Recurrent Chron... Recurrent Plasm... Refractory Chro... Refractory Plas... Splenomegaly Thrombocytopeni... Weight Loss	Laboratory Biom... Metformin Hydro... Pharmacological... Ritonavir Quality-of-Life Questionnaire	18 Years -	City of Hope Medical Center

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