Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Nausea

Vomiting

Pain

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Signs and Symptoms, Digestive

Esophageal Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

docetaxel

steroid therapy

questionnaire administration

nausea and vomiting therapy

pain therapy

quality-of-life assessment

standard follow-up care

radiation therapy

Hugo Ford, MD

RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping to control symptoms caused by cancer. It is not yet known whether these treatments are more effective when given with or without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

PURPOSE: This randomized phase II trial is studying symptom control given together with docetaxel to see how well it works compared with symptom control given without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

OBJECTIVES:

Primary

* To compare overall survival of patients with relapsed adenocarcinoma of the esophagus or stomach after treatment with docetaxel and active symptom control vs active symptom control alone.

Secondary

* To determine the time to documented progression in patients treated with docetaxel.
* To assess response rates to docetaxel in patients treated with docetaxel.
* To determine toxicity of docetaxel in patients treated with docetaxel.
* To assess the quality of life of these patients.
* To evaluate the health economic impact.

OUTLINE: This is a multicenter study.

Patients are stratified according to stage (locally advanced vs metastatic), site of disease (esophagus vs esophagogastric junction vs stomach), duration of response to prior chemotherapy (no response vs response duration \< 3 months vs response duration 3-6 months), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive docetaxel IV over 1 hour on day 1 and active symptom control (e.g., analgesics \[including opioids\], antiemetics, steroids, palliative radiotherapy) daily.
* Arm II: Patients receive active symptom control as in arm I. Courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients in arm I undergo tissue biopsy collection at baseline and after 3 courses of treatment for biomarker analysis.

Quality of life is assessed by the QLQ-C30 and QLQ-STO22 questionnaires at baseline and at 3, 6, 9, 12, 18, and 24 weeks. Health resource use is assessed by the EQ-5D questionnaire at baseline and then periodically during and after treatment.

After completion of study treatment, patients are followed up every 6 weeks for 1 year and then every 3 months thereafter.

Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer

Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma

Cambridge University Hospitals NHS Foundation Trust

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.

Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.

Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

acupressure therapy

management of therapy complications

Suzanne L. Dibble, DNSc, RN, PhD

RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.

OBJECTIVES:

* Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone.
* Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms.

* Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes.
* Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site.
* Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.

Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Fatigue

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Lung Adenocarcinoma

fatigue assessment and management

Andrea Bezjak, MD, MSC, FRCPC

RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung cancer. It is not yet known which regimen of radiation therapy is most effective in relieving symptoms in patients with non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.

OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two regimens in these patients. III. Compare the quality of life and survival of patients treated with these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5 weeks, then every 2 months for 1 year.

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer

A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer

NCIC Clinical Trials Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer	NCT00978549	Adenocarcinoma ... Esophageal Canc... Gastric Cancer Nausea and Vomi... Pain	docetaxel steroid therapy questionnaire a... nausea and vomi... pain therapy quality-of-life... standard follow... radiation thera...	18 Years -	National Cancer Institute (NCI)
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer	NCT00046865	Breast Cancer Drug-induced Na...	acupressure the... management of t... nausea and vomi...	18 Years -	M.D. Anderson Cancer Center
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer	NCT00978549	Adenocarcinoma ... Esophageal Canc... Gastric Cancer Nausea and Vomi... Pain	docetaxel steroid therapy questionnaire a... nausea and vomi... pain therapy quality-of-life... standard follow... radiation thera...	18 Years -	National Cancer Institute (NCI)
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer	NCT00003685	Fatigue Lung Cancer Nausea and Vomi... Pain Pulmonary Compl... Quality of Life	fatigue assessm... nausea and vomi... pain therapy quality-of-life... radiation thera...	16 Years - 120 Years	Canadian Cancer Trials Group

Spots Global Cancer Trial Database for nausea and vomiting therapy