Neoplasms

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Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Emetics

Ondansetron

Granisetron

Dexamethasone

Cisplatin

Dexamethasone acetate

Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.

Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Real Acupressure Band

Placebo Acupressure Band

Thomas Williams McLean, MD

Lee Dupuis, PhD

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea.

PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.

OBJECTIVES:

Primary

* To compare the control of chemotherapy-induced nausea (CIN) in the acute phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Secondary

* To compare the control of CIN in the delayed phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.
* To compare the control of chemotherapy-induced vomiting and retching (CIV) in the acute and delayed phases provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

OUTLINE: This is a multicenter study. Patients are stratified according chemotherapy regimen and anti-emetic Regimen 5-HT3 agonists (ondansetron or granisetron.) Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.
* Arm II: Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Patients, parents, or guardians are instructed to complete an impatient and an outpatient diaries on nausea severity and the time of each emetic episode. Patients, parents, or guardians also complete a questionnaire about acupressure at the end of the study.

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

CIN = Chemotherapy-Induced Nausea. The acute phase began with administration of the first chemotherapy dose of a chemotherapy block and continued until 24 hours after administration of the last chemotherapy dose of the block. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Nausea severity during the acute phase of chemotherapy is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the acute phase were included. The duration of the acute phase varied with chemotherapy regimen, according to study design.

CIN = Chemotherapy-Induced Nausea. The delayed phase began at the end of the acute phase and continued until the first chemotherapy dose of the next chemotherapy block. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. Nausea severity is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the delayed phase were included.

CIV = Chemotherapy-Induced Vomiting. Total Duration of Study includes both acute and delayed phases. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. A breakthrough antiemetic agent is defined as a medication that is administered or taken in order to relieve or treat (rather than prevent) nausea or vomiting. An antiemetic agent that is prescribed and/or administered on an "as needed" basis is considered to be a breakthrough antiemetic. Complete CIV Control during the acute and delayed phases is defined as no emetic episodes and no breakthrough anti-emetic agents administered during the phase of interest. Partial CIV Control is defined as 1 or 2 emetic episodes in any 24 ho

National Cancer Institute (NCI)

University of South Florida

Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.

Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.

Real Acupressure Band: Acupressure wristband

Arm I- Real Acupressure Bands

Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Placebo Acupressure Band: Sham wristband

Arm II- Placebo Acupressure Bands

Total

Age, Continuous

Sex: Female, Male

Diagnosis

93 participants were allocated to acupressure bands and 83 received the intervention. 94 participants were allocated to the placebo bands and 82 received the intervention.

Thomas W. McLean, MD

Day 1

Day 2

Day 3

Days 4-7

The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day.

Efficacy of Treatment on CIN During Acute Phase of Chemotherapy

Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy

Acute Phase

Delayed Phase

The overall number of participants analyzed is 83 participants in Arm I and 82 participants in Arm II. In the acute phase, 165 patients provided at least 1 PeNAT (Pediatric Nausea Assessment Tool) score. In the delayed phase, 144 patients contributed at least 1 PeNAT score.

Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Brain Neoplasms

Body Weight

Osteosarcoma

Neuroblastoma

Sarcoma

Liposarcoma

Lymphoma

Weight Loss

Body Weight Changes

Wilms Tumor

Sarcoma, Ewing

Carcinosarcoma

Mixed Tumor, Mullerian

Testicular Neoplasms

Sarcoma, Endometrial Stromal

Chondrosarcoma

Fibrosarcoma

Neuroectodermal Tumors, Primitive, Peripheral

Wasting Syndrome

Cachexia

Hemangiosarcoma

Kidney Neoplasms

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Neurofibrosarcoma

Lymphoma, Large-Cell, Anaplastic

Leukemia, Myelomonocytic, Acute

Hepatoblastoma

Gliosarcoma

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Sarcoma, Clear Cell

Leukemia, Promyelocytic, Acute

Leukemia, Monocytic, Acute

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Mast-Cell Sarcoma

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Soft Tissue Sarcoma

Lymphosarcoma

Acute Graft Versus Host Disease

Wilms' Tumor

Ewing Sarcoma

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Endometrial Stromal Sarcoma

Brain Tumor, Childhood

Anaplastic Astrocytoma

Ovarian Germ Cell Tumor

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Epithelioid Sarcoma

Testicular Germ Cell Tumor

Anaplastic Large Cell Lymphoma

Uterine Sarcoma

Nonseminomatous Germ Cell Tumor

Anaplastic Oligodendroglioma

Alveolar Soft Part Sarcoma

Diffuse Astrocytoma

Malignant Germ Cell Tumor

Pilocytic Astrocytoma

Uterine Carcinosarcoma

Anti-Allergic Agents

Cyproheptadine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Serotonin

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

Patients receive an oral placebo twice daily for 8 weeks.

cyproheptadine hydrochloride

placebo

Jeffrey P. Krischer, PhD

RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.

OBJECTIVES:

Primary

* To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.

Secondary

* To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
* Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.

OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.

* Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
* Arm II: Patients receive an oral placebo twice daily for 8 weeks.

Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.

Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Arm I Cyproheptadine Hydrochloride

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Arm II Placebo

United States

Region of Enrollment

Angelina Fink, Research Base Administrator

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline

Severity of Weight Loss

Pattern of Weight in the Study Population

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy	NCT01346267	Central Nervous... Chemotherapy-in... Unspecified Chi...	Real Acupressur... Placebo Acupres...	4 Years - 18 Years	University of South Florida
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer	NCT01132547	Cancer	cyproheptadine ... placebo	2 Years - 21 Years	University of South Florida

Spots Global Cancer Trial Database for childhood supratentorial primitive neuroectodermal tumor