Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Esophageal Neoplasms

Fatigue

Pancreatic Neoplasms

Sarcoma

Head and Neck Neoplasms

Brain Neoplasms

Uterine Neoplasms

Carcinoma, Bronchogenic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Esophageal Diseases

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Esophageal Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients phyiscal activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy.

The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.

Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.

Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.

Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C

Cihan Gani, MD, PD

Daniel Zips, MD, Prof.

Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy

Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)

This endpoint will be evaluated by the FACT-G (Functional Assessment of Cancer Therapy - General) total scores of the FACIT (Functional Assessment of Chronic Illness Therapy) questionnaire (physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well-being values 0-28, 28 better outcome

University Hospital Tuebingen

Senior Physician

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Antineoplastic Agents

Cisplatin

EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2

Hypofractionated EBRT

EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2

Standard EBRT

Kasra Kolahdouzan, M.D.

Ebrahim Esmati, M.D.

Afsaneh Maddah-Safaei, M.D.

Uterine cervix cancer can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment which can reduce costs and patient exposure. The aim of our study is to determine the non-inferiority of hypofractionated radiotherapy compared with conventional treatment.

In this study we aim to determine if clinical response and toxicity of radiotherapy hypofractionation is non-inferior to the conventional treatment. We will enroll 60 eligible patients with cervical cancer stage IB to IIIC and randomly allocate them into the intervention (hypofractionation) group or the control (standard) groups. The patients in the intervention group will receive external beam radiotherapy(EBRT) to a total dose of 40 Gy in 15 fractions within 3 weeks concurrently with weekly chemotherapy with cisplatin 40mg/m2 (total of 3 cycles). Whereas, the control group will receive EBRT to a total dose of 45 Gy in 25 fractions within 5 weeks concurrently with weekly chemotherapy with cisplatin 40mg/m2 (total of 5 cycles). All patients from both groups will undergo high dose rate brachytherapy one week after completion of EBRT to a total dose of 28 Gy per 4 weekly sessions. Patients will be evaluated regarding early and late toxicities as described by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the completion of brachytherapy, and at 3 months, 6 months, and 3 years from completion of treatment. Also, clinical response will be evaluated through dynamic contrast enhanced pelvic MRI 3 months, 1 year, and 3 years after completion of brachytherapy.

Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer

Comparison of Clinical Response and Toxicity of Hypo-fractionated Chemoradiation With Standard Treatment in Patients With Uterine Cervix Cancer

Early treatment-related toxicity within 3 months after completion of treatment as defined by CTCAE 5.0.

Early response to treatment at 3 months after treatment completion based on dynamic contrast-enhanced pelvic MRI findings

Late treatment-related toxicity within 1 and 3 years after completion of treatment as defined by CTCAE 5.0.

Time from randomization to progression(based on MRI and physical examination), death, or last follow up; whichever that occurs first

Time from randomization to death from cervical cancer or last follow-up; whichever that occurs first.

Time from randomization to death from any reason or last follow-up; whichever that occurs first.

Tehran University of Medical Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy	NCT04517019	Bronchial Carci... Esophageal Carc... Tumor of the Br... Head and Neck C... Pancreas Cancer Sarcoma Cervix Uteri Ca...	Fitness tracker...	18 Years -	University Hospital Tuebingen
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer	NCT04831437	Cervix Uteri Ca...	Hypofractionate... Standard EBRT	18 Years - 85 Years	Tehran University of Medical Sciences
Clinical Response and Toxicity of Hypo-fractionated Chemoradiotherapy in Cervix Cancer	NCT04831437	Cervix Uteri Ca...	Hypofractionate... Standard EBRT	18 Years - 85 Years	Tehran University of Medical Sciences

Spots Global Cancer Trial Database for cervix uteri cancer