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Status:

COMPLETED

Support for People Undergoing Chemotherapy

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborating Sponsors:

American Cancer Society, Inc.

Conditions:

Quality of Life

Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Chemotherapy adversely affects quality of life in cancer patients. Both stress management training and exercise training have been shown to improve quality of life. These two types of training have no...

Eligibility Criteria

Inclusion

  • participants must:
  • Be diagnosed with cancer
  • Be scheduled to receive cytotoxic chemotherapy for at least 14 weeks
  • Be ≥18 years of age or older
  • Have an ECOG performance status of 0, 1, or 2
  • Be capable of speaking and reading English
  • Be able to provide informed consent

Exclusion

  • ECOG of 3 or greater
  • Presence of contraindications to participating in moderate intensity exercise including:
  • . metastases to weight-bearing sites (spine, pelvis, lower extremities)
  • . active infections
  • . cardiomyopathy or congestive heart failure
  • . severe pulmonary or ventilatory disease (FEV 1.0\<50%)
  • . large pleural effusions or pericardial effusions
  • . anemia (Hgb \<8g/dL)
  • . neutropenia (absolute neutrophil count \< 0.05 x 10(9th)/L)
  • . severe osteoporosis (\> 2.5 SD below age and gender norms)
  • . thrombocytopenia (platelets \< 20 x 10(9th)/L)
  • . hyponatremia (Na+ \< 130 mmol/L)
  • . hypokalemia (K+ ≤ 3.0 mmol/L)
  • . hypercalcemia (Ca++ \> 6.5 mmol/L)
  • . abnormal ECG
  • . sensorimotor deficits sufficient to impede unassisted walking
  • Receipt of intravenous chemotherapy administration in the past 2 months
  • Prescription for chronotropic, sympathomimetic, or inotropic/vasoactive medications
  • Presence of other contraindications as determined by the attending oncologist and research staff

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

471 Patients enrolled

Trial Details

Trial ID

NCT00740038

Start Date

August 1 2006

End Date

August 1 2012

Last Update

February 23 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612