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← Cervical Cancer

NCT00577317 · STUDY IN CONTEXT

Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cance

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.

Eligible and evaluable participants. There were no evaluable participants due to low accrual.

→

secondary · NOT_POSTED

Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.

Source null

→

secondary · NOT_POSTED

Compliance with treatment was to be measured between both arms of the study. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.

Source null

→

secondary · NOT_POSTED

Pain in affected limb was to be measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.

Source null

→

secondary · NOT_POSTED

Incidence of deep-vein thrombosis was to be measured during the study. Unfortunately, due to low accrual study was closed. Analysis will not be performed.

Source null

→

secondary · NOT_POSTED

Incidence of cellulitis in both arms was planned to measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer
nct id
NCT00577317
qol key
qol-0001
source section id
NCT00577317-om-0001
source outcome index
1
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
measure definition
Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
time frame
From registration to study discontinuation. A maximum of 7 months.
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer
nct id
NCT00577317
trial label
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cance
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0000
    source section id
    NCT00577317-om-0000
    source outcome index
    0
    endpoint
    Lower-extremity Volumes for Both Unaffected and Affected Legs
    endpoint definition
    Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable participants. There were no evaluable participants due to low accrual.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0001
    source section id
    NCT00577317-om-0001
    source outcome index
    1
    endpoint
    Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
    endpoint definition
    Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0002
    source section id
    NCT00577317-om-0002
    source outcome index
    2
    endpoint
    Compliance With Treatment as Assessed by the Number of Days Per Week Using MLD or Flexitouch System and Duration/Day of MLD and Flexitouch System Treatment
    endpoint definition
    Compliance with treatment was to be measured between both arms of the study. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0003
    source section id
    NCT00577317-om-0003
    source outcome index
    3
    endpoint
    Pain in Affected Limb
    endpoint definition
    Pain in affected limb was to be measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0004
    source section id
    NCT00577317-om-0004
    source outcome index
    4
    endpoint
    Incidence of Deep-vein Thrombosis
    endpoint definition
    Incidence of deep-vein thrombosis was to be measured during the study. Unfortunately, due to low accrual study was closed. Analysis will not be performed.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0005
    source section id
    NCT00577317-om-0005
    source outcome index
    5
    endpoint
    Incidence of Cellulitis
    endpoint definition
    Incidence of cellulitis in both arms was planned to measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
    time origin
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm 1
    regimen
    Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Management of Therapy Complications: Receive standard home maintenance therapy and perform self-manual lymphatic drainage Quality-of-Life Assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00577317-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II
    regimen
    Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks Management of Therapy Complications: Receive Flexitouch home maintenance therapy Quality-of-Life Assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00577317-om-0000#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    harm key
    EG000
    source section id
    NCT00577317-ae
    event group key
    EG000
    event group label
    Arm 1
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    Source null
    event definition
    Two participants enrolled in this study. The study was closed early due to poor accrual.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    harm key
    EG001
    source section id
    NCT00577317-ae
    event group key
    EG001
    event group label
    Arm II
    serious affected
    0
    serious at risk
    2
    other affected
    0
    other at risk
    2
    frequency threshold
    0
    collection period
    Source null
    event definition
    Two participants enrolled in this study. The study was closed early due to poor accrual.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00577317
    qol key
    qol-0001
    source section id
    NCT00577317-om-0001
    source outcome index
    1
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
    measure definition
    Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants.
    time frame
    From registration to study discontinuation. A maximum of 7 months.
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice